Respiratory FailureNCT06409897
Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients
A study testing Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevation in people with Respiratory Failure and Pulmonary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The effects of different degrees of head-of-bed elevation on respiratory mechanics are poorly explored in the literature, and no study has investigated such effects using electrical impedance tomography, esophageal and gastric balloons to identify the ideal angle for optimizing respiratory mechanics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Pulmonary Disease
- What is being tested?
- Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Oct 2023to 1 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under invasive mechanical ventilation, intubated due to respiratory failure
Who cannot join
- Hemodynamics instability, contraindication for monitoring with esophageal and gastric catheters, and Electrical impedance tomography, no authorization of medical team of the intensive care unit, and contraindication for lung recruitment maneuver
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 05403-900
Marcelo BP Amato, MD, PhD, 3061-7361, marcelo.amato@hc.fm.usp.br
Ana C Cardoso dos Santos, PT, +5511968022077, cardosocsfisio@gmail.com
About this study
The effects of different degrees of head-of-bed elevation on respiratory mechanics are poorly explored in the literature, and no study has investigated such effects using electrical impedance tomography, esophageal and gastric balloons to identify the ideal angle for optimizing respiratory mechanics. The hypothesis is that there is a optimal degree for the respiratory mechanics.
Read the detailed description
Respiratory mechanics and regional ventilation will be monitored using electrical impedance tomography (Enlight 2100, Timpel Medical®, Brazil) . Esophageal and gastric pressures will be obtained through esophageal and gastric balloon catheters (Nutrivent®) (validation concerning to modified Baydur maneuver - slope delta esophageal pressure/delta airway pressure (0,8-1,2). We are using the hardware Pneumodrive (Biônica, Recife, Brazil) to record and store the esophageal, gastric and airway pressures, these data will be analyzed using LabVIEW 7.1 (Pneumobench).
Initially, patients will be positioned at 0 degrees of head-of-bed elevation, and after stabilization of the plethysmogram, data from electrical impedance tomography, hemodynamics, and arterial blood gas will be collected (arterial blood will be drawn by a nurse or physician). Sequentially and in the same manner, the bed will be adjusted to 10, 20, 30, and 40 degrees (the same data will be collected, except for the arterial blood sample, which will only be collected at the 40-degree elevation). Then, an alveolar recruitment maneuver will be performed, followed by a PEEP titration with 10-degree of head-of-bed elevation.
- Conditions
- Respiratory Failure, Pulmonary Disease
- Being tested
- Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevation
- Keywords
- Respiratory Failure, Pulmonary disease, Intensive care, Respiratory Mechanics
- Medical subject headings
- Respiratory Insufficiency, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevationOther
Patients will be sequentially positioned at 0, 10, 20, 30, and 40 degrees of head-of-bed elevation. An alveolar recruitment maneuver will be performed. For patients with body mass index ≤ 30 kg/m^2, the maneuver will be conducted in pressure control mode, pressure control = 15 cmH2O, respiratory rate = 20 breaths per minute, and the PEEP will be increased in steps of 5 up to 30 cmH2O. For patients with body mass index > 30, the PEEP will be increased up to 35. Then, a PEEP titration will be performed, tidal volume = 5 mL/Kg, respiratory rate = 25 breaths per minute, and the PEEP will be decreased from 24 down to 4 cmH2O in steps of 2 cmH2O with 30 seconds in each PEEP level. The PEEP titration software of Enlight 2100 will be used to determine the ideal PEEP, defined as the PEEP level with a collapse less than 5%. The alveolar recruitment maneuver will be performed again to reopen the lungs. Then, data will be collected, as with the 0 and 40-degree steps, with ideal PEEP.
| Study group | Role | What they receive |
|---|---|---|
| Sequential head-of-bed elevation | Other | Patients will be positioned at 0 degrees of head-of-bed elevation, and after stabilization of the plethysmogram, data from electrical impedance tomography, hemodynamics, and arterial blood gas will be collected (arterial blood will be drawn by a nurse or physician). Sequentially and in the same manner, the bed will be adjusted to 10, 20, 30, and 40 degrees (the same data will be collected, except for the arterial blood sample, which will only be collected at the 40-degree elevation). Then, an alveolar recruitment maneuver will be performed, followed by a PEEP titration with 10-degree of head-of-bed elevation, and the data will be collected just as in the 0° and 40° steps. Receives: Other: Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory system compliance
Respiratory system compliance (mL/cmH2O) will be measured using electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil).
Measured: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Lung compliance
Lung compliance (mL/cmH2O) will be measured offline using the esophageal pressure tracings. By knowing the respiratory system and chest wall compliance, the lung compliance will be calculated. (1/respiratory system compliance = 1/chest wall compliance + 1/lung compliance)
Measured: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Chest wall compliance
Chest wall compliance (mL/cmH2O) will be measured offline using the esophageal pressure tracings.
Chest wall compliance = tidal volume / delta esophageal pressure
Measured: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Secondary outcomes (4)
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: At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Pressure between patient skin surface and the mattress
ForeSite PT (XSENSOR Technology Corporation, Patient Monitoring System) will be used to measure the pressure between patient's skin surface and the mattress. A monitor connected to this sensor provides continuous pressure monitoring, and the data will exported for subsequent offline analysis of the sacral and occipital regions.
Measured: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Hemodynamics satefy of keeping low degrees of head of the elevation
Arterial blood pressure provided by the multiparameter monitor. Data will be noted in each degree.
Measured: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Gastric pressure
Gastric pressure will be measured offline using the gastric pressure tracings.
Measured: At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start15 Oct 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 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 FailureStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the participants will be exposed to the same situations (head-of-bed elevations), in the same order. An alveolar recruitment maneuver followed by a PEEP titration with 10-degree head-of-bed elevation will be performed.
- Masking
- None (open label)
- Enrolment
- 40 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 Amato, MD, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409897
- Sponsor's protocol ID
- 68464523.9.0000.0068
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
PubMed 9449727Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Villar J, Kacmarek RM, Perez-Mendez L, Aguirre-Jaime A. A high positive end-expiratory pressure, low tidal volume ventilatory strategy improves outcome in persistent acute respiratory distress syndrome: a randomized, controlled trial. Crit Care Med. 2006 May;34(5):1311-8. doi: 10.1097/01.CCM.0000215598.84885.01.
PubMed 16557151Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.
PubMed 20197533Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
PubMed 25693014Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
PubMed 19186406Galiatsou E, Kostanti E, Svarna E, Kitsakos A, Koulouras V, Efremidis SC, Nakos G. Prone position augments recruitment and prevents alveolar overinflation in acute lung injury. Am J Respir Crit Care Med. 2006 Jul 15;174(2):187-97. doi: 10.1164/rccm.200506-899OC. Epub 2006 Apr 27.
PubMed 16645177Mutoh T, Guest RJ, Lamm WJ, Albert RK. Prone position alters the effect of volume overload on regional pleural pressures and improves hypoxemia in pigs in vivo. Am Rev Respir Dis. 1992 Aug;146(2):300-6. doi: 10.1164/ajrccm/146.2.300.
PubMed 1489116Roldan R, Rodriguez S, Barriga F, Tucci M, Victor M, Alcala G, Villamonte R, Suarez-Sipmann F, Amato M, Brochard L, Tusman G. Sequential lateral positioning as a new lung recruitment maneuver: an exploratory study in early mechanically ventilated Covid-19 ARDS patients. Ann Intensive Care. 2022 Feb 12;12(1):13. doi: 10.1186/s13613-022-00988-9.
PubMed 35150355Richard JC, Maggiore SM, Mancebo J, Lemaire F, Jonson B, Brochard L. Effects of vertical positioning on gas exchange and lung volumes in acute respiratory distress syndrome. Intensive Care Med. 2006 Oct;32(10):1623-6. doi: 10.1007/s00134-006-0299-y. Epub 2006 Aug 1.
PubMed 16896856Dellamonica J, Lerolle N, Sargentini C, Hubert S, Beduneau G, Di Marco F, Mercat A, Diehl JL, Richard JC, Bernardin G, Brochard L. Effect of different seated positions on lung volume and oxygenation in acute respiratory distress syndrome. Intensive Care Med. 2013 Jun;39(6):1121-7. doi: 10.1007/s00134-013-2827-x. Epub 2013 Jan 24.
PubMed 23344832Marrazzo F, Spina S, Forlini C, Guarnieri M, Giudici R, Bassi G, Bastia L, Bottiroli M, Fumagalli R, Langer T. Effects of Trunk Inclination on Respiratory Mechanics in Patients with COVID-19-associated Acute Respiratory Distress Syndrome: Let's Always Report the Angle! Am J Respir Crit Care Med. 2022 Mar 1;205(5):582-584. doi: 10.1164/rccm.202110-2360LE. No abstract available.
PubMed 34982652Mahran GSK, Abd-Elshafy SK, Abd El Neem MM, Sayed JA. The effect of reference position versus right lateral position on the intra-abdominal pressure in mechanically ventilated patients. Journal of Nursing Education and Practice. 2018;8(6).
Vasquez DG, Berg-Copas GM, Wetta-Hall R. Influence of semi-recumbent position on intra-abdominal pressure as measured by bladder pressure. J Surg Res. 2007 May 15;139(2):280-5. doi: 10.1016/j.jss.2006.10.023. Epub 2006 Dec 8.
PubMed 17161433McBeth PB, Zygun DA, Widder S, Cheatham M, Zengerink I, Glowa J, Kirkpatrick AW. Effect of patient positioning on intra-abdominal pressure monitoring. Am J Surg. 2007 May;193(5):644-7; discussion 647. doi: 10.1016/j.amjsurg.2007.01.013.
PubMed 17434374
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06409897
- Acronym / sponsor ID
- 68464523.9.0000.0068
- Conditions
- Respiratory Failure, Pulmonary Disease
- Keywords
- Respiratory Failure, Pulmonary disease, Intensive care, Respiratory Mechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 10 May 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 effects of different degrees of head-of-bed elevation on respiratory mechanics are poorly explored in the literature, and no study has investigated such effects using electrical impedance tomography, esophageal and gastric balloons to identify the ideal angle for optimizing respiratory mechanics. The hypothesis is that there is a optimal degree for the respiratory mechanics.
Detailed description
Respiratory mechanics and regional ventilation will be monitored using electrical impedance tomography (Enlight 2100, Timpel Medical®, Brazil) . Esophageal and gastric pressures will be obtained through esophageal and gastric balloon catheters (Nutrivent®) (validation concerning to modified Baydur maneuver - slope delta esophageal pressure/delta airway pressure (0,8-1,2). We are using the hardware Pneumodrive (Biônica, Recife, Brazil) to record and store the esophageal, gastric and airway pressures, these data will be analyzed using LabVIEW 7.1 (Pneumobench).
Initially, patients will be positioned at 0 degrees of head-of-bed elevation, and after stabilization of the plethysmogram, data from electrical impedance tomography, hemodynamics, and arterial blood gas will be collected (arterial blood will be drawn by a nurse or physician). Sequentially and in the same manner, the bed will be adjusted to 10, 20, 30, and 40 degrees (the same data will be collected, except for the arterial blood sample, which will only be collected at the 40-degree elevation). Then, an alveolar recruitment maneuver will be performed, followed by a PEEP titration with 10-degree of head-of-bed elevation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the participants will be exposed to the same situations (head-of-bed elevations), in the same order. An alveolar recruitment maneuver followed by a PEEP titration with 10-degree head-of-bed elevation will be performed.
| Arm | Type | Receives |
|---|---|---|
| Sequential head-of-bed elevation | Other | Other: Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevationPatients will be positioned at 0 degrees of head-of-bed elevation, and after stabilization of the plethysmogram, data from electrical impedance tomography, hemodynamics, and arterial blood gas will be collected (arterial blood will be drawn by a nurse or physician). Sequentially and in the same manner, the bed will be adjusted to 10, 20, 30, and 40 degrees (the same data will be collected, except for the arterial blood sample, which will only be collected at the 40-degree elevation). Then, an alveolar recruitment maneuver will be performed, followed by a PEEP titration with 10-degree of head-of-bed elevation, and the data will be collected just as in the 0° and 40° steps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients under invasive mechanical ventilation, intubated due to respiratory failure
Key exclusion criteria (1 listed)
- Hemodynamics instability, contraindication for monitoring with esophageal and gastric catheters, and Electrical impedance tomography, no authorization of medical team of the intensive care unit, and contraindication for lung recruitment maneuver
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 |
|---|---|---|
| Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevationPatients will be sequentially positioned at 0, 10, 20, 30, and 40 degrees of head-of-bed elevation. An alveolar recruitment maneuver will be performed. For patients with body mass index ≤ 30 kg/m^2, the maneuver will be conducted in pressure control mode, pressure control = 15 cmH2O, respiratory rate = 20 breaths per minute, and the PEEP will be increased in steps of 5 up to 30 cmH2O. For patients with body mass index > 30, the PEEP will be increased up to 35. Then, a PEEP titration will be performed, tidal volume = 5 mL/Kg, respiratory rate = 25 breaths per minute, and the PEEP will be decreased from 24 down to 4 cmH2O in steps of 2 cmH2O with 30 seconds in each PEEP level. The PEEP titration software of Enlight 2100 will be used to determine the ideal PEEP, defined as the PEEP level with a collapse less than 5%. The alveolar recruitment maneuver will be performed again to reopen the lungs. Then, data will be collected, as with the 0 and 40-degree steps, with ideal PEEP. | Other | Sequential head-of-bed elevation |
Primary outcome
Respiratory system compliance
Time frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Respiratory system compliance (mL/cmH2O) will be measured using electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil).
Lung compliance
Time frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Lung compliance (mL/cmH2O) will be measured offline using the esophageal pressure tracings. By knowing the respiratory system and chest wall compliance, the lung compliance will be calculated. (1/respiratory system compliance = 1/chest wall compliance + 1/lung compliance)
Chest wall compliance
Time frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Chest wall compliance (mL/cmH2O) will be measured offline using the esophageal pressure tracings. Chest wall compliance = tidal volume / delta esophageal pressure
4 secondary outcomes
Oxygenation
Time frame: At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Pressure between patient skin surface and the mattress
Time frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Hemodynamics satefy of keeping low degrees of head of the elevation
Time frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Gastric pressure
Time frame: At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 9449727Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 16557151Villar J, Kacmarek RM, Perez-Mendez L, Aguirre-Jaime A. A high positive end-expiratory pressure, low tidal volume ventilatory strategy improves outcome in persistent acute respiratory distress syndrome: a randomized, controlled trial. Crit Care Med. 2006 May;34(5):1311-8. doi: 10.1097/01.CCM.0000215598.84885.01.
- Background: PubMed 20197533Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.
- Background: PubMed 25693014Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
- 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 16645177Galiatsou E, Kostanti E, Svarna E, Kitsakos A, Koulouras V, Efremidis SC, Nakos G. Prone position augments recruitment and prevents alveolar overinflation in acute lung injury. Am J Respir Crit Care Med. 2006 Jul 15;174(2):187-97. doi: 10.1164/rccm.200506-899OC. Epub 2006 Apr 27.
- Background: PubMed 1489116Mutoh T, Guest RJ, Lamm WJ, Albert RK. Prone position alters the effect of volume overload on regional pleural pressures and improves hypoxemia in pigs in vivo. Am Rev Respir Dis. 1992 Aug;146(2):300-6. doi: 10.1164/ajrccm/146.2.300.
- Background: PubMed 35150355Roldan R, Rodriguez S, Barriga F, Tucci M, Victor M, Alcala G, Villamonte R, Suarez-Sipmann F, Amato M, Brochard L, Tusman G. Sequential lateral positioning as a new lung recruitment maneuver: an exploratory study in early mechanically ventilated Covid-19 ARDS patients. Ann Intensive Care. 2022 Feb 12;12(1):13. doi: 10.1186/s13613-022-00988-9.
- Background: PubMed 16896856Richard JC, Maggiore SM, Mancebo J, Lemaire F, Jonson B, Brochard L. Effects of vertical positioning on gas exchange and lung volumes in acute respiratory distress syndrome. Intensive Care Med. 2006 Oct;32(10):1623-6. doi: 10.1007/s00134-006-0299-y. Epub 2006 Aug 1.
- Background: PubMed 23344832Dellamonica J, Lerolle N, Sargentini C, Hubert S, Beduneau G, Di Marco F, Mercat A, Diehl JL, Richard JC, Bernardin G, Brochard L. Effect of different seated positions on lung volume and oxygenation in acute respiratory distress syndrome. Intensive Care Med. 2013 Jun;39(6):1121-7. doi: 10.1007/s00134-013-2827-x. Epub 2013 Jan 24.
- Background: PubMed 34982652Marrazzo F, Spina S, Forlini C, Guarnieri M, Giudici R, Bassi G, Bastia L, Bottiroli M, Fumagalli R, Langer T. Effects of Trunk Inclination on Respiratory Mechanics in Patients with COVID-19-associated Acute Respiratory Distress Syndrome: Let's Always Report the Angle! Am J Respir Crit Care Med. 2022 Mar 1;205(5):582-584. doi: 10.1164/rccm.202110-2360LE. No abstract available.
- 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 Amato, 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 Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevation in people with Respiratory Failure and Pulmonary Disease, 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 1 inclusion and 1 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 10 May 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?
Contact Marcelo BP Amato, MD, PhD (3061-7361, marcelo.amato@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory system compliance (time frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation). The study lists 3 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 NCT06409897, 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 10 May 2024.