Respiratory InsufficiencyNCT06698913
Feasibility and Efficacy of Automated Lateral Decubitus Therapy in Hypoxemic Respiratory Failure
A study testing Rotational Therapy in people with Respiratory Insufficiency and ARDS, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The mortality of patients with acute respiratory distress syndrome (ARDS) remains high despite recent advances in lung-protective strategies and even after the overall improvement in intensive care (management of sepsis, hemodynamics, organ failure, and control of nosocomial infections). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Insufficiency, ARDS, Post Cardiac Surgery Patients
- What is being tested?
- Rotational Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Dec 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sample 1-
- Patients under mechanical ventilation
- Immediate postoperative period of open-heart valve surgery and myocardial revascularization
- PaO2/FiO2 ratio ≤ 250 mmHg (calculated from values obtained in arterial blood gas analysis)
- Values collected with:
- FiO2 ≥ 0.6 PEEP ≥ 8 cmH2O
Show all 15Show fewer
- Sample 2 -
- Patients under controlled/assisted mechanical ventilation, not yet eligible for weaning
- PaO2/FiO2 ratio < 250 mmHg (calculated using arterial blood gas values)
- Values collected with:
- FiO2 = 0.6 PEEP > 5 cmH2O
- Acute condition onset less than 2 weeks ago
- Mechanical ventilation duration of less than 1 week
- Asymmetric ventilation distribution (65%/35%) on the functional map from Electrical Impedance Tomography (EIT) in the supine position
- Both Samples:
Who cannot join
- Need for norepinephrine ≥ 1 mcg/kg/min or mean arterial pressure ≤ 65 mmHg;
- Cardiac arrhythmias or bleeding leading to hemodynamic instability;
- Need for surgical revision and/or mechanical circulatory assistance;
- Contraindication to hypercapnia, such as intracranial hypertension or acute coronary syndrome;
- Neurological diseases or symptoms, such as a history of seizures;
- Dependence on a cardiac pacemaker;
Show all 12Show fewer
- Air leakage through chest drains, undrained pneumothorax, or subcutaneous emphysema;
- Previous lung disease or surgery, or use of home oxygen therapy;
- Comorbidities with a life expectancy \< 6 months;
- Pulmonary artery systolic pressure \> 45 mmHg;
- Myocardial revascularization using the mammary artery;
- Medical refusal for the patient\'s participation in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-900
About this study
The mortality of patients with acute respiratory distress syndrome (ARDS) remains high despite recent advances in lung-protective strategies and even after the overall improvement in intensive care (management of sepsis, hemodynamics, organ failure, and control of nosocomial infections). The use of mechanical ventilation (MV) plays a fundamental therapeutic role in this scenario. It allows for respiratory muscle rest, maintenance of oxygen transport to tissues, elimination of CO2 production, and finally, lung rest and protection in patients with excessive ventilatory demand.
On the other hand, recent studies have also shown that MV can cause iatrogenic injury and inflammation in the lung parenchyma, imposing a significant mechanical energy load and dissipation in the lung parenchyma (mechanotransduction). This effect is more pronounced in patients with low lung compliance or in those receiving inadvertently high tidal volumes, resulting in high distending pressure. Thus, despite being life-saving in the short term, MV may perpetuate or exacerbate pre-existing lung injury.
Read more
Various strategies have been proposed to aid in the ventilatory management of patients with ARDS. Among them, the use of higher PEEP values and the prone position have proven beneficial, especially when resulting in the stabilization of diseased alveoli or even promoting the recruitment of new alveolar units, associated with improved gas exchange. Both maneuvers, however, involve considerable risks: PEEP often causes impairments to venous return, and the prone position presents technical/logistical limitations for its widespread use, or even severe adverse effects during its implementation (ocular injury, accidental extubation, arrhythmias, catheter disconnection, etc.).
The hypothesis of this study is that automated lateral decubitus positioning (performed by a rotational bed with proper patient support), guided by monitoring through Electrical Impedance Tomography (EIT), could replace or minimize the need for prone positioning or the need for higher PEEPs in critical patients, resulting in effective alveolar recruitment and improvements in gas exchange, compliance, and lung aeration without affecting the hemodynamic condition.
Read the detailed description
The objective will be to estimate the efficacy and validate the feasibility of this alveolar recruitment protocol through the automated rotation of the patient, without the need for high airway pressures.Also the aim to demonstrate that this protocol is safe, with fewer repercussions on the hemodynamics of critically ill patients. To achieve this, a prospective, randomized study were conduct in two populations of critically ill patients: Sample-1) patients in the postoperative period of cardiac surgery, with a PF ratio of less than 250 (N=50 patients) admitted to the post-anesthesia care unit of Incor for extubation, and Sample-2) patients with ARDS or acute hypoxemic respiratory failure, with a PF ratio of less than 250, requiring mechanical ventilation (N=30 additional patients), and necessarily presenting an asymmetric (\>65%/35%) distribution of ventilation on the functional map of Electrical Impedance Tomography (EIT) while in the supine position. A stratified randomization (1:1) within each of these samples of 30 patients will be done by computer.
For Sample 1 - the control group will undergo an ARDSNet-type ventilatory strategy, with PEEP adjustment according to BMI, based on previous studies that evaluated PEEP titrated by EIT in relation to BMI; and for Sample 2 - the ARDSNet-type ventilatory strategy, with PEEP adjustment according to the \"low PEEP/FIO2\" oxygenation table. All patients will remain on mechanical ventilation for at least 4 hours and will be monitored with EIT throughout the study. In postoperative patients, the rotation of the treatment group will follow the sequence \"supine - lateral - supine - lateral - supine,\" with 10 minutes in each supine position and 20 minutes in each lateral position, and the first rotated side is defined as the lung with less ventilation being placed in a non-dependent position with a maximum PEEP of 24 cmH2O. In patients with asymmetric injury (acute hypoxemic respiratory failure), the lateralization sequence will be \"supine-lateral with the better lung dependent-supine,\" meaning that the rotation will be unilateral, with 20-minute lateral position times alternated with another 10 minutes in the supine position. Recruitment maneuvers routinely used by the institution may be used as a rescue for any patient and will be mandatory at the end of the 4-hour study period in all postoperative patients (Sample 1, both treatment arms). The maneuvers will be performed with controlled pressure ventilation, a maximum PEEP of 30 cmH2O, with maximum inspiratory pressures of 50 cmH2O, for a maximum time of 30 seconds. These maneuvers will not be applied to patients with asymmetric injury (Sample 2, acute hypoxemic respiratory failure).
The main variables for comparison between the arms of each population sample will be: a) lung collapse and hyperdistension, b) shunt and PF ratio, c) ventilatory ratio (as a \"surrogate\" for dead space), d) global lung mechanics, e) regional mechanics by EIT, and f) continuous measurements of cardiac output (Volume-View, Baxter), frequency, and mean arterial pressure. These variables will be collected during the baseline period and after the recruitment maneuver for Sample 1, and after 24 hours of intervention for Sample 2.
The main hypothesis is that rotational therapy can increase regional transpulmonary pressure (in the non-dependent region after rotation), resulting in effective alveolar recruitment, evidenced by an improvement in PF ratio, global compliance, and regional compliance after returning to the supine position in both patient populations. In the case of patients with asymmetric lung injury (Sample 2), a effect is expecting within the following 24 hours compared to the control therapy. In the case of patients with symmetric injury, these effects can also be compared with the effects obtained by the more aggressive and traditional recruitment maneuver to be performed at the end of the observation period. As a secondary hypothesis, it was to intend to demonstrate that the therapy will cause minimal hemodynamic impairment compared to the control arm, and also less hemodynamic impairment when compared to the traditional recruitment maneuver at the end of the study (for postoperative patients).
- Conditions
- Respiratory Insufficiency, ARDS, Post Cardiac Surgery Patients, Hypoxemic Respiratory Failure
- Being tested
- Rotational Therapy
- Keywords
- alveolar recruitment, post cardiac surgery, lateral position, Hypoxemic Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational TherapyProcedure or surgery
Sample1- Ventilator settings where adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment for both sides. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O. Sample2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Positioning | Experimental | Sample1- Ventilator settings where adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment for both sides. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O. Sample2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT. Receives: Procedure: Rotational Therapy |
| Control Group | No intervention | Sample 1- The ventilator settings adjusted with PEEP based on BMI and remained in the supine position for the entire time. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O.Sample 2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Collapse
Lung Collapse will be measured using the information provided by the EIT that uses the Costa method
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Lung compliance
Lung compliance (mL/cmH2O) will be measured using the information provided by the EIT that uses the movement equation
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Oxygenation
Oxigenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen ratio. Partial pressure arterial oxygen measured in the blood sample at the of each step and the fraction inspired oxygen set during the blood sample collection will be used.
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Shunt
Oxygenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen at 1 ratio and partial pressure arterial oxygen and partial pressure of oxygen in venous blood will be collected an calculated manual using the formula Q/Qt= (CcO2-Ca02)-(CcO1-CvO2) where CcO2 (Pulmonary end-capillary O2 content); CvO2 (Mixed venous O2 content); CaO2(Arterial O2 content).
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Driving Pressure
Driving Pressure (cmH2O) will be measured using the information provided by the EIT that uses the movement equation
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
End Expiratory Lung Volume
will be measured using the information provided by the Electrical Tomography Impedance
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Lung Hyperextension
Lung Hyperextension (%) will be measured using the information provided by the EIT that uses the Costa method
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Plateau Pressure
Plateau Pressure( cmH2O) will be measured using the information provided by the EIT that uses the movement equation
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Ventilatory Distribution
will be measured using the information provided by the Electrical Tomography Impedance
Measured: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Secondary outcomes (10)
Stroke Volume
The hemodynamics were assessed through Stroke Volume using the EV1000™ clinical monitoring platform.
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Diastolic Blood Pressure
The hemodynamics were assessed through Diastolic Blood Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil).
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and
Stroke Volume Index
The hemodynamics were assessed through Stroke Volume Index using the EV1000™ clinical monitoring platform.
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Cardiac Index
The hemodynamics were assessed through Cardiac Index using the EV1000™ clinical monitoring platform.
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Cardiac Output
The hemodynamics were assessed through Cardiac Output using the EV1000™ clinical monitoring platform.
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Systolic Volume Variation
The hemodynamics were assessed through Systolic Volume Variation using the EV1000™ clinical monitoring platform.
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Mean Arterial Pressure
The hemodynamics were assessed through Mean Artial Pressure using the EV1000™ clinical monitoring platform for continous record and the the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil) for especifics times of colleted data.
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Pulse Rate
The hemodynamics were assessed through Pulse Rate using the EV1000™ clinical monitoring platform.
Measured: the record throughout the duration of the protocol in the 20seconds of period of time
Systolic Blood Pressure
The hemodynamics were assessed through Diastolic Blood Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil).
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and
Heart Rate
The hemodynamics were assessed through Diastolic Blood Pressure using the multiparameter monitor DX-2020 (Dixtal, São Paulo, Brazil).
Measured: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start13 Dec 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In Sample 1, intervention group patients had ventilator settings adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment, monitored by plethysmogram. PEEP was increased up to 4 cmH2O as needed. Afterward, patients returned to supine, and the process was repeated on the other side. The control group had similar ventilator settings but stayed supine. Both groups had an alveolar recruitment maneuver with increased pressures. In Sample 2, all patients underwent a 2-minute recruitment maneuver, followed by a 5-minute PEEP titration. The EIT-PEEP was identified and selected as the first PEEP above the crossing point of collapse and hyperdistension curves. Patients were then randomized, and PEEP was increased progressively based on randomization. The intervention group avoided traditional recruitment maneuvers, increasing PEEP gradually. This was followed by 4 hours of observation and a 24-hour follow-up
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo BP, MD PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698913
- Sponsor's protocol ID
- 44692221.5.0000.0068
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
PubMed 30260897Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
PubMed 19186406Hewitt N, Bucknall T, Faraone NM. Lateral positioning for critically ill adult patients. Cochrane Database Syst Rev. 2016 May 12;2016(5):CD007205. doi: 10.1002/14651858.CD007205.pub2.
PubMed 27169365Tongyoo S, Vilaichone W, Ratanarat R, Permpikul C. The effect of lateral position on oxygenation in ARDS patients: a pilot study. J Med Assoc Thai. 2006 Nov;89 Suppl 5:S55-61.
PubMed 17718246Remolina C, Khan AU, Santiago TV, Edelman NH. Positional hypoxemia in unilateral lung disease. N Engl J Med. 1981 Feb 26;304(9):523-5. doi: 10.1056/NEJM198102263040906. No abstract available.
PubMed 6779161Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
PubMed 27400909Fessler HE, Talmor DS. Should prone positioning be routinely used for lung protection during mechanical ventilation? Respir Care. 2010 Jan;55(1):88-99.
PubMed 20040127Puybasset L, Cluzel P, Chao N, Slutsky AS, Coriat P, Rouby JJ. A computed tomography scan assessment of regional lung volume in acute lung injury. The CT Scan ARDS Study Group. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1644-55. doi: 10.1164/ajrccm.158.5.9802003.
PubMed 9817720Pelosi P, D'Andrea L, Vitale G, Pesenti A, Gattinoni L. Vertical gradient of regional lung inflation in adult respiratory distress syndrome. Am J Respir Crit Care Med. 1994 Jan;149(1):8-13. doi: 10.1164/ajrccm.149.1.8111603.
PubMed 8111603Malbouisson LM, Busch CJ, Puybasset L, Lu Q, Cluzel P, Rouby JJ. Role of the heart in the loss of aeration characterizing lower lobes in acute respiratory distress syndrome. CT Scan ARDS Study Group. Am J Respir Crit Care Med. 2000 Jun;161(6):2005-12. doi: 10.1164/ajrccm.161.6.9907067.
PubMed 10852781Lai-Fook SJ, Rodarte JR. Pleural pressure distribution and its relationship to lung volume and interstitial pressure. J Appl Physiol (1985). 1991 Mar;70(3):967-78. doi: 10.1152/jappl.1991.70.3.967.
PubMed 2033012Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.
PubMed 28973363Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, Davies AR, Hand LE, Zhou Q, Thabane L, Austin P, Lapinsky S, Baxter A, Russell J, Skrobik Y, Ronco JJ, Stewart TE; Lung Open Ventilation Study Investigators. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637-45. doi: 10.1001/jama.299.6.637.
PubMed 18270352Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.
PubMed 17038660Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.
PubMed 24283226
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Automated Lateral Decubitus Therapy in Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT06698913
- Acronym / sponsor ID
- 44692221.5.0000.0068
- Conditions
- Respiratory Insufficiency, ARDS, Post Cardiac Surgery Patients, Hypoxemic Respiratory Failure
- Keywords
- alveolar recruitment, post cardiac surgery, lateral position, Hypoxemic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mortality of patients with acute respiratory distress syndrome (ARDS) remains high despite recent advances in lung-protective strategies and even after the overall improvement in intensive care (management of sepsis, hemodynamics, organ failure, and control of nosocomial infections). The use of mechanical ventilation (MV) plays a fundamental therapeutic role in this scenario. It allows for respiratory muscle rest, maintenance of oxygen transport to tissues, elimination of CO2 production, and finally, lung rest and protection in patients with excessive ventilatory demand.
On the other hand, recent studies have also shown that MV can cause iatrogenic injury and inflammation in the lung parenchyma, imposing a significant mechanical energy load and dissipation in the lung parenchyma (mechanotransduction). This effect is more pronounced in patients with low lung compliance or in those receiving inadvertently high tidal volumes, resulting in high distending pressure. Thus, despite being life-saving in the short term, MV may perpetuate or exacerbate pre-existing lung injury.
Various strategies have been proposed to aid in the ventilatory management of patients with ARDS. Among them, the use of higher PEEP values and the prone position have proven beneficial, especially when resulting in the stabilization of diseased alveoli or even promoting the recruitment of new alveolar units, associated with improved gas exchange. Both maneuvers, however, involve considerable risks: PEEP often causes impairments to venous return, and the prone position presents technical/logistical limitations for its widespread use, or even severe adverse effects during its implementation (ocular injury, accidental extubation, arrhythmias, catheter disconnection, etc.).
The hypothesis of this study is that automated lateral decubitus positioning (performed by a rotational bed with proper patient support), guided by monitoring through Electrical Impedance Tomography (EIT), could replace or minimize the need for prone positioning or the need for higher PEEPs in critical patients, resulting in effective alveolar recruitment and improvements in gas exchange, compliance, and lung aeration without affecting the hemodynamic condition.
Detailed description
The objective will be to estimate the efficacy and validate the feasibility of this alveolar recruitment protocol through the automated rotation of the patient, without the need for high airway pressures.Also the aim to demonstrate that this protocol is safe, with fewer repercussions on the hemodynamics of critically ill patients. To achieve this, a prospective, randomized study were conduct in two populations of critically ill patients: Sample-1) patients in the postoperative period of cardiac surgery, with a PF ratio of less than 250 (N=50 patients) admitted to the post-anesthesia care unit of Incor for extubation, and Sample-2) patients with ARDS or acute hypoxemic respiratory failure, with a PF ratio of less than 250, requiring mechanical ventilation (N=30 additional patients), and necessarily presenting an asymmetric (\>65%/35%) distribution of ventilation on the functional map of Electrical Impedance Tomography (EIT) while in the supine position. A stratified randomization (1:1) within each of these samples of 30 patients will be done by computer.
For Sample 1 - the control group will undergo an ARDSNet-type ventilatory strategy, with PEEP adjustment according to BMI, based on previous studies that evaluated PEEP titrated by EIT in relation to BMI; and for Sample 2 - the ARDSNet-type ventilatory strategy, with PEEP adjustment according to the \"low PEEP/FIO2\" oxygenation table. All patients will remain on mechanical ventilation for at least 4 hours and will be monitored with EIT throughout the study. In postoperative patients, the rotation of the treatment group will follow the sequence \"supine - lateral - supine - lateral - supine,\" with 10 minutes in each supine position and 20 minutes in each lateral position, and the first rotated side is defined as the lung with less ventilation being placed in a non-dependent position with a maximum PEEP of 24 cmH2O. In patients with asymmetric injury (acute hypoxemic respiratory failure), the lateralization sequence will be \"supine-lateral with the better lung dependent-supine,\" meaning that the rotation will be unilateral, with 20-minute lateral position times alternated with another 10 minutes in the supine position. Recruitment maneuvers routinely used by the institution may be used as a rescue for any patient and will be mandatory at the end of the 4-hour study period in all postoperative patients (Sample 1, both treatment arms). The maneuvers will be performed with controlled pressure ventilation, a maximum PEEP of 30 cmH2O, with maximum inspiratory pressures of 50 cmH2O, for a maximum time of 30 seconds. These maneuvers will not be applied to patients with asymmetric injury (Sample 2, acute hypoxemic respiratory failure).
The main variables for comparison between the arms of each population sample will be: a) lung collapse and hyperdistension, b) shunt and PF ratio, c) ventilatory ratio (as a \"surrogate\" for dead space), d) global lung mechanics, e) regional mechanics by EIT, and f) continuous measurements of cardiac output (Volume-View, Baxter), frequency, and mean arterial pressure. These variables will be collected during the baseline period and after the recruitment maneuver for Sample 1, and after 24 hours of intervention for Sample 2.
The main hypothesis is that rotational therapy can increase regional transpulmonary pressure (in the non-dependent region after rotation), resulting in effective alveolar recruitment, evidenced by an improvement in PF ratio, global compliance, and regional compliance after returning to the supine position in both patient populations. In the case of patients with asymmetric lung injury (Sample 2), a effect is expecting within the following 24 hours compared to the control therapy. In the case of patients with symmetric injury, these effects can also be compared with the effects obtained by the more aggressive and traditional recruitment maneuver to be performed at the end of the observation period. As a secondary hypothesis, it was to intend to demonstrate that the therapy will cause minimal hemodynamic impairment compared to the control arm, and also less hemodynamic impairment when compared to the traditional recruitment maneuver at the end of the study (for postoperative patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In Sample 1, intervention group patients had ventilator settings adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment, monitored by plethysmogram. PEEP was increased up to 4 cmH2O as needed. Afterward, patients returned to supine, and the process was repeated on the other side. The control group had similar ventilator settings but stayed supine. Both groups had an alveolar recruitment maneuver with increased pressures. In Sample 2, all patients underwent a 2-minute recruitment maneuver, followed by a 5-minute PEEP titration. The EIT-PEEP was identified and selected as the first PEEP above the crossing point of collapse and hyperdistension curves. Patients were then randomized, and PEEP was increased progressively based on randomization. The intervention group avoided traditional recruitment maneuvers, increasing PEEP gradually. This was followed by 4 hours of observation and a 24-hour follow-up
| Arm | Type | Receives |
|---|---|---|
| Lateral Positioning | Experimental | Procedure: Rotational TherapySample1- Ventilator settings where adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment for both sides. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O. Sample2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT. |
| Control Group | No intervention | –Sample 1- The ventilator settings adjusted with PEEP based on BMI and remained in the supine position for the entire time. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O.Sample 2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sample 1-
- Patients under mechanical ventilation
- Immediate postoperative period of open-heart valve surgery and myocardial revascularization
- PaO2/FiO2 ratio ≤ 250 mmHg (calculated from values obtained in arterial blood gas analysis)
- Values collected with:
Key exclusion criteria (12 listed)
- Need for norepinephrine ≥ 1 mcg/kg/min or mean arterial pressure ≤ 65 mmHg;
- Cardiac arrhythmias or bleeding leading to hemodynamic instability;
- Need for surgical revision and/or mechanical circulatory assistance;
- Contraindication to hypercapnia, such as intracranial hypertension or acute coronary syndrome;
- Neurological diseases or symptoms, such as a history of seizures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotational TherapySample1- Ventilator settings where adjusted with PEEP based on BMI, followed by a 2 cmH2O increase and 20 minutes in a lateral position at 30 degrees for lung recruitment for both sides. And at the end were subjected to an alveolar recruitment maneuver with pressure increases up to a plateau pressure of 45 cmH2O. Sample2- A recruitment maneuver followed by PEEP titration is performed, selecting the PEEP that is above the crossing point between the collapse and hyperdistension curves provided by EIT. And the the PEEP-ARDSNet will be selected according to the low PEEP-FIO2 table from the ARDSNet protocol. Observations are made at 4 and 24 hours, with PEEP at 24 hours adjusted to the level identified by EIT. | Procedure or surgery | Lateral Positioning |
Primary outcome
Lung Collapse
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Lung Collapse will be measured using the information provided by the EIT that uses the Costa method
Lung compliance
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Lung compliance (mL/cmH2O) will be measured using the information provided by the EIT that uses the movement equation
Oxygenation
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Oxigenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen ratio. Partial pressure arterial oxygen measured in the blood sample at the of each step and the fraction inspired oxygen set during the blood sample collection will be used.
Shunt
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Oxygenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen at 1 ratio and partial pressure arterial oxygen and partial pressure of oxygen in venous blood will be collected an calculated manual using the formula Q/Qt= (CcO2-Ca02)-(CcO1-CvO2) where CcO2 (Pulmonary end-capillary O2 content); CvO2 (Mixed venous O2 content); CaO2(Arterial O2 content).
Driving Pressure
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Driving Pressure (cmH2O) will be measured using the information provided by the EIT that uses the movement equation
End Expiratory Lung Volume
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
will be measured using the information provided by the Electrical Tomography Impedance
Lung Hyperextension
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Lung Hyperextension (%) will be measured using the information provided by the EIT that uses the Costa method
Plateau Pressure
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
Plateau Pressure( cmH2O) will be measured using the information provided by the EIT that uses the movement equation
Ventilatory Distribution
Time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.
will be measured using the information provided by the Electrical Tomography Impedance
10 secondary outcomes
Stroke Volume
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Diastolic Blood Pressure
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and
Stroke Volume Index
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Cardiac Index
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Cardiac Output
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Systolic Volume Variation
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Mean Arterial Pressure
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and the record throughout the duration of the protocol in the 20seconds of period of time
Pulse Rate
Time frame: the record throughout the duration of the protocol in the 20seconds of period of time
Systolic Blood Pressure
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization and
Heart Rate
Time frame: the specific time was in each supine position, three at total; during the recruitment maneuver; after 5 and 15 minutes after both lateralization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 30260897Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
- Background: PubMed 19186406Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
- Background: PubMed 27169365Hewitt N, Bucknall T, Faraone NM. Lateral positioning for critically ill adult patients. Cochrane Database Syst Rev. 2016 May 12;2016(5):CD007205. doi: 10.1002/14651858.CD007205.pub2.
- Background: PubMed 17718246Tongyoo S, Vilaichone W, Ratanarat R, Permpikul C. The effect of lateral position on oxygenation in ARDS patients: a pilot study. J Med Assoc Thai. 2006 Nov;89 Suppl 5:S55-61.
- Background: PubMed 6779161Remolina C, Khan AU, Santiago TV, Edelman NH. Positional hypoxemia in unilateral lung disease. N Engl J Med. 1981 Feb 26;304(9):523-5. doi: 10.1056/NEJM198102263040906. No abstract available.
- Background: PubMed 27400909Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
- Background: PubMed 20040127Fessler HE, Talmor DS. Should prone positioning be routinely used for lung protection during mechanical ventilation? Respir Care. 2010 Jan;55(1):88-99.
- Background: PubMed 9817720Puybasset L, Cluzel P, Chao N, Slutsky AS, Coriat P, Rouby JJ. A computed tomography scan assessment of regional lung volume in acute lung injury. The CT Scan ARDS Study Group. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1644-55. doi: 10.1164/ajrccm.158.5.9802003.
- Background: PubMed 8111603Pelosi P, D'Andrea L, Vitale G, Pesenti A, Gattinoni L. Vertical gradient of regional lung inflation in adult respiratory distress syndrome. Am J Respir Crit Care Med. 1994 Jan;149(1):8-13. doi: 10.1164/ajrccm.149.1.8111603.
- Background: PubMed 10852781Malbouisson LM, Busch CJ, Puybasset L, Lu Q, Cluzel P, Rouby JJ. Role of the heart in the loss of aeration characterizing lower lobes in acute respiratory distress syndrome. CT Scan ARDS Study Group. Am J Respir Crit Care Med. 2000 Jun;161(6):2005-12. doi: 10.1164/ajrccm.161.6.9907067.
- Background: PubMed 2033012Lai-Fook SJ, Rodarte JR. Pleural pressure distribution and its relationship to lung volume and interstitial pressure. J Appl Physiol (1985). 1991 Mar;70(3):967-78. doi: 10.1152/jappl.1991.70.3.967.
- Background: PubMed 28973363Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo BP, MD PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotational Therapy in people with Respiratory Insufficiency and ARDS, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Collapse (time frame: Right before first lateralization, 10 minutes after the first lateralization, 10 minutes after the second lateralization, 10 minutes after the alveolar recruitment maneuver using the increase of pressures.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698913, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.