Pulmonary AtelectasisNCT05670483
Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery
A study testing Use Of APRV mode of Ventilation in people with Pulmonary Atelectasis and Morbid Obesity, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this Randomized Clinical trial is to to investigate if the use of Air Pressure Release Ventilation in morbidly obese patients undergoing open heart surgery will improve post operative pulmonary outcomes 60 Patients will be randomized into two groups according to the mode of ventilation used into: Group A… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Atelectasis, Morbid Obesity, Pulmonary Complication
- What is being tested?
- Use Of APRV mode of Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2022to 1 Jun 2023
- 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
- Age ≥18 y.
- Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
- Class III Obesity (Morbid obesity): BMI ≥ 40.0 kg/m².
Who cannot join
- Patients with obstructive lung disease (asthma or chronic obstructive pulmonary disease).
- Pneumothorax or Surgical emphysema.
- Mechanical ventilation prior to the operation.
- Patient Refusal.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cardiothoracic Academy, Ain Shams University Hospitals
Cairo, 11566
University President, MD, +2026847819, gd.research@asu.edu.eg
Mohamed A. Alhadidy, MD
About this study
Official title: Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery to Improve Post Operative Pulmonary Outcomes
The goal of this Randomized Clinical trial is to to investigate if the use of Air Pressure Release Ventilation in morbidly obese patients undergoing open heart surgery will improve post operative pulmonary outcomes 60 Patients will be randomized into two groups according to the mode of ventilation used into: Group A: airway pressure release ventilation (APRV) group (30 Patients) Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode
Read the detailed description
Obesity is an ongoing worldwide problem, and as such, weight-related issues arise especially in the intensive care unit (ICU). Morbid obesity adversely affects physiology; restricted thoracic movement and increased intra-abdominal pressure leads to reduced lung volumes and compliance resulting frequently in atelectasis, ventilation-perfusion mismatch.
Cardiac surgical patients are at particular risk for PPCs. The use of cardiopulmonary bypass (CPB) is responsible for a systemic inflammatory response and oxidative stress, leading to pulmonary ischemia-reperfusion injury. Mechanical ventilation frequently is disrupted during CPB, thus inducing atelectasis. Some proposed mechanisms are leukocyte activation, fluid accumulation in the lung and atelectasis.
Atelectasis is a highly prevalent pulmonary complication in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and an important cause of postoperative hypoxemia. Pulmonary collapse occurs early after the induction of anesthesia and persists for several days postoperatively. Studies based on thoracic computed tomography (CT) have shown that pulmonary collapse is mainly distributed to the dependent regions close to the diaphragm and may encompass up to 35% of the overall lung parenchyma which predispose to pneumonia.
This impairment of lung function, particularly oxygenation of the blood, is a common and potentially serious complication after cardiac surgery. It has been shown to persist for as long as one week after the operation.
In obese patients, the functional residual capacity (FRC) and lung compliance are reduced, and thus the elastic work of breathing (WOB) is elevated. By applying continuous positive airway pressure (CPAP), the FRC is restored, and inspiration starts from a more favorable pressure-volume relationship, facilitating spontaneous ventilation, and improves oxygenation.
APRV was originally described as a mode to treat acute lung injury in patients and attempt to maintain the level of airway pressure without reducing cardiac function, delivering mechanical breaths without excessive airway pressure and allowing unrestricted spontaneous ventilation. 6 APRV is essentially a high-level continuous positive airway pressure (CPAP) mode that is terminated for a very brief period of time. It is this short release period that allows carbon dioxide to be cleared. The lengthy time during which the high-level CPAP is present results in substantial recruitment of alveoli of markedly different regional time constants, at rather low gas flow rates and lower airway pressures. The establishment of intrinsic PEEP by the short release time enhances oxygenation. Carbon dioxide clearance is aided by recruitment of the patient's lung at close to total lung capacity; elastic recoil creates large volume gas flow during the release period.
Recent advances in the understanding of the respiratory physiologic alterations in the obese patient suggest that ''open lung'' ventilation approaches such as APRV recruit lung alveolar volumes without exacerbating lung injury and maintain acceptable gas exchange. Given the spontaneous nature of the mode, it is hypothesized that there should be no need for continuous infusions of neuromuscular blocking agents in patients placed on this mode of ventilation.
This may result in a shorter duration of intensive care unit (ICU) stay. Furthermore, because patients may be ventilated at lower airway pressures than are required with cyclic ventilation, there may be a reduced need for pressor support of hemodynamics to ensure oxygen delivery which is favorable in cardiac surgical patients.
So, the investigators hypothesize that APRV may be a preferred mode of ventilation in morbidly obese patients after cardiac surgery.
- Being tested
- Use Of APRV mode of Ventilation, Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode
- Keywords
- APRV, Morbid Obesity, Cardiac surgery, Pulmonary Complications
- Medical subject headings
- Pulmonary Atelectasis, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use Of APRV mode of VentilationDevice
Post operatively, Patients will be ventilated with APRV mode using GE Carescape R860 ventilator Initial Settings15
- P high at the P plateau (or desired P mean + 3cm H2O). keep P high below 30-35 cm H2O
- T high at 4-6 seconds
- P low at 0
- T low at 0.5 to 0.8 seconds.
- ATC (automatic tube compensation) on.
- FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of APRV will start as following, P-High will be lowered 2 or 3 cm of H2O pressure at a time, and T Low will be lengthened in 0.5-2.0 s increments, depending on patient tolerance. When the P-high reaches 10 cmH2O and the Thigh reaches 12-15 seconds, change the mode to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation.
Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control modeDevice
Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode using GE Carescape R860 ventilator Initial Settings: 16
- Tidal Volume 6-8 ml/kg predicted body weight
- Respiratory rate (RR) 14 /min
- Positive end expiratory pressure (PEEP)= 5 cmH2o
- Pressure Support (PS) = 10 cmH2o
- Inspiratory time 1.4 Sec
- FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of mechanical ventilation will be done by switching the ventilation to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation.
| Study group | Role | What they receive |
|---|---|---|
| APRV group | Active comparator | Group A: APRV group (30 Patients) Post operatively, Patients will be ventilated with APRV mode using GE Carescape R860 ventilator Initial Settings15
1. P high at the P plateau (or desired P mean + 3cm H2O). keep P high below 30-35 cm H2O
2. T high at 4-6 seconds
3. P low at 0
4. T low at 0.5 to 0.8 seconds.
5. ATC (automatic tube compensation) on.
6. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of APRV will start as following, P-High will be lowered 2 or 3 cm of H2O pressure at a time, and T Low will be lengthened in 0.5-2.0 s increments, depending on patient tolerance. When the P-high reaches 10 cmH2O and the Thigh reaches 12-15 seconds, change the mode to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation. Receives: Device: Use Of APRV mode of Ventilation |
| Standard group | Active comparator | Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode using GE Carescape R860 ventilator Initial Settings: 16
1. Tidal Volume 6-8 ml/kg predicted body weight
2. Respiratory rate (RR) 14 /min
3. Positive end expiratory pressure (PEEP)= 5 cmH2o
4. Pressure Support (PS) = 10 cmH2o
5. Inspiratory time 1.4 Sec
6. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Receives: Device: Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
PO2/FIO2 (P/F) ratio
Will be recorded at admission, 6 hours,12 hours, 24 hours and 48 hours
Measured: up to 3 days
Time of mechanical ventilation
Hours of Mechanical ventilation
Measured: up to 3 days
Secondary outcomes (7)
Need for Non-Invasive ventilation (NIV)
Need of high flow nasal cannula (HFNC) or Non-Invasive continuous positive airway pressure (NICPAP)
Measured: up to 3 days
Occurrence Respiratory complications
Occurrence of Pneumonia identified by clinical signs, chest Xray and lung ultrasound
Measured: up to 1 week
Effect on Blood pressure
Mean arterial systemic blood pressure (MAP) recorded at admission, 6 hours, 12 hours and 24 hours
Measured: up to 1 day
Need for Vasopressors and Inotropes
Vasopressors and Inotropes needs guided by Vasoactive-Inotrope score (VIS) measured at admission, 6 hours, 12 hours and 24 hours
Measured: up to 1 day
length of ICU stay
Duration of patient stays in ICU in days
Measured: up to 3 days
length of Hospital stay
Duration of hospital stay after surgery in days.
Measured: up to 10 days
Mortality
Post operative Death
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start3 Dec 2022
- Primary completion3 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alaaeldin Abdelmoneem Alhadidy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670483
- Sponsor's protocol ID
- FMASU R 243/2022
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Villavicencio MA, Sundt TM 3rd, Daly RC, Dearani JA, McGregor CG, Mullany CJ, Orszulak TA, Puga FJ, Schaff HV. Cardiac surgery in patients with body mass index of 50 or greater. Ann Thorac Surg. 2007 Apr;83(4):1403-11. doi: 10.1016/j.athoracsur.2006.10.076.
PubMed 17383347Ranucci M, Ballotta A, La Rovere MT, Castelvecchio S; Surgical and Clinical Outcome Research (SCORE) Group. Postoperative hypoxia and length of intensive care unit stay after cardiac surgery: the underweight paradox? PLoS One. 2014 Apr 7;9(4):e93992. doi: 10.1371/journal.pone.0093992. eCollection 2014.
PubMed 24709952Neves FH, Carmona MJ, Auler JO Jr, Rodrigues RR, Rouby JJ, Malbouisson LM. Cardiac compression of lung lower lobes after coronary artery bypass graft with cardiopulmonary bypass. PLoS One. 2013 Nov 11;8(11):e78643. doi: 10.1371/journal.pone.0078643. eCollection 2013.
PubMed 24244331Daoud EG. Airway pressure release ventilation. Ann Thorac Med. 2007 Oct;2(4):176-9. doi: 10.4103/1817-1737.36556.
PubMed 19727373Ge H, Lin L, Xu Y, Xu P, Duan K, Pan Q, Ying K. Airway Pressure Release Ventilation Mode Improves Circulatory and Respiratory Function in Patients After Cardiopulmonary Bypass, a Randomized Trial. Front Physiol. 2021 Jun 3;12:684927. doi: 10.3389/fphys.2021.684927. eCollection 2021.
PubMed 34149459Testerman GM, Breitman I, Hensley S. Airway pressure release ventilation in morbidly obese surgical patients with acute lung injury and acute respiratory distress syndrome. Am Surg. 2013 Mar;79(3):242-6.
PubMed 23461947Kaplan LJ, Bailey H, Formosa V. Airway pressure release ventilation increases cardiac performance in patients with acute lung injury/adult respiratory distress syndrome. Crit Care. 2001 Aug;5(4):221-6. doi: 10.1186/cc1027. Epub 2001 Jul 2.
PubMed 11511336Bonatti G, Robba C, Ball L, Silva PL, Rocco PRM, Pelosi P. Controversies when using mechanical ventilation in obese patients with and without acute distress respiratory syndrome. Expert Rev Respir Med. 2019 May;13(5):471-479. doi: 10.1080/17476348.2019.1599285. Epub 2019 Apr 5.
PubMed 30919705Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
PubMed 31054241Manjunath V, Reddy BG, Prasad SR. Is airway pressure release ventilation, a better primary mode of post-operative ventilation for adult patients undergoing open heart surgery? A prospective randomised study. Ann Card Anaesth. 2021 Jul-Sep;24(3):288-293. doi: 10.4103/aca.ACA_98_20.
PubMed 34269256Sawano Y, Miyazaki M, Shimada H, Kadoi Y. Optimal fentanyl dosage for attenuating systemic hemodynamic changes, hormone release and cardiac output changes during the induction of anesthesia in patients with and without hypertension: a prospective, randomized, double-blinded study. J Anesth. 2013 Aug;27(4):505-11. doi: 10.1007/s00540-012-1552-x. Epub 2013 Jan 12.
PubMed 23314694Members of the Working Party; Nightingale CE, Margarson MP, Shearer E, Redman JW, Lucas DN, Cousins JM, Fox WT, Kennedy NJ, Venn PJ, Skues M, Gabbott D, Misra U, Pandit JJ, Popat MT, Griffiths R; Association of Anaesthetists of Great Britain; Ireland Society for Obesity and Bariatric Anaesthesia. Peri-operative management of the obese surgical patient 2015: Association of Anaesthetists of Great Britain and Ireland Society for Obesity and Bariatric Anaesthesia. Anaesthesia. 2015 Jul;70(7):859-76. doi: 10.1111/anae.13101. Epub 2015 May 7.
PubMed 25950621Alwardt CM, Redford D, Larson DF. General anesthesia in cardiac surgery: a review of drugs and practices. J Extra Corpor Technol. 2005 Jun;37(2):227-35.
PubMed 16117465Modrykamien A, Chatburn RL, Ashton RW. Airway pressure release ventilation: an alternative mode of mechanical ventilation in acute respiratory distress syndrome. Cleve Clin J Med. 2011 Feb;78(2):101-10. doi: 10.3949/ccjm.78a.10032.
PubMed 21285342Fischer MO, Brotons F, Briant AR, Suehiro K, Gozdzik W, Sponholz C, Kirkeby-Garstad I, Joosten A, Nigro Neto C, Kunstyr J, Parienti JJ, Abou-Arab O, Ouattara A; VENICE study group. Postoperative Pulmonary Complications After Cardiac Surgery: The VENICE International Cohort Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2344-2351. doi: 10.1053/j.jvca.2021.12.024. Epub 2021 Dec 25.
PubMed 35094928
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery to Improve Post Operative Pulmonary Outcomes
- ClinicalTrials.gov ID
- NCT05670483
- Acronym / sponsor ID
- FMASU R 243/2022
- Keywords
- APRV, Morbid Obesity, Cardiac surgery, Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 3 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 4 Jan 2023 (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 goal of this Randomized Clinical trial is to to investigate if the use of Air Pressure Release Ventilation in morbidly obese patients undergoing open heart surgery will improve post operative pulmonary outcomes 60 Patients will be randomized into two groups according to the mode of ventilation used into: Group A: airway pressure release ventilation (APRV) group (30 Patients) Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode
Detailed description
Obesity is an ongoing worldwide problem, and as such, weight-related issues arise especially in the intensive care unit (ICU). Morbid obesity adversely affects physiology; restricted thoracic movement and increased intra-abdominal pressure leads to reduced lung volumes and compliance resulting frequently in atelectasis, ventilation-perfusion mismatch.
Cardiac surgical patients are at particular risk for PPCs. The use of cardiopulmonary bypass (CPB) is responsible for a systemic inflammatory response and oxidative stress, leading to pulmonary ischemia-reperfusion injury. Mechanical ventilation frequently is disrupted during CPB, thus inducing atelectasis. Some proposed mechanisms are leukocyte activation, fluid accumulation in the lung and atelectasis.
Atelectasis is a highly prevalent pulmonary complication in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and an important cause of postoperative hypoxemia. Pulmonary collapse occurs early after the induction of anesthesia and persists for several days postoperatively. Studies based on thoracic computed tomography (CT) have shown that pulmonary collapse is mainly distributed to the dependent regions close to the diaphragm and may encompass up to 35% of the overall lung parenchyma which predispose to pneumonia.
This impairment of lung function, particularly oxygenation of the blood, is a common and potentially serious complication after cardiac surgery. It has been shown to persist for as long as one week after the operation.
In obese patients, the functional residual capacity (FRC) and lung compliance are reduced, and thus the elastic work of breathing (WOB) is elevated. By applying continuous positive airway pressure (CPAP), the FRC is restored, and inspiration starts from a more favorable pressure-volume relationship, facilitating spontaneous ventilation, and improves oxygenation.
APRV was originally described as a mode to treat acute lung injury in patients and attempt to maintain the level of airway pressure without reducing cardiac function, delivering mechanical breaths without excessive airway pressure and allowing unrestricted spontaneous ventilation. 6 APRV is essentially a high-level continuous positive airway pressure (CPAP) mode that is terminated for a very brief period of time. It is this short release period that allows carbon dioxide to be cleared. The lengthy time during which the high-level CPAP is present results in substantial recruitment of alveoli of markedly different regional time constants, at rather low gas flow rates and lower airway pressures. The establishment of intrinsic PEEP by the short release time enhances oxygenation. Carbon dioxide clearance is aided by recruitment of the patient's lung at close to total lung capacity; elastic recoil creates large volume gas flow during the release period.
Recent advances in the understanding of the respiratory physiologic alterations in the obese patient suggest that ''open lung'' ventilation approaches such as APRV recruit lung alveolar volumes without exacerbating lung injury and maintain acceptable gas exchange. Given the spontaneous nature of the mode, it is hypothesized that there should be no need for continuous infusions of neuromuscular blocking agents in patients placed on this mode of ventilation.
This may result in a shorter duration of intensive care unit (ICU) stay. Furthermore, because patients may be ventilated at lower airway pressures than are required with cyclic ventilation, there may be a reduced need for pressor support of hemodynamics to ensure oxygen delivery which is favorable in cardiac surgical patients.
So, the investigators hypothesize that APRV may be a preferred mode of ventilation in morbidly obese patients after cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APRV group | Active comparator | Device: Use Of APRV mode of VentilationGroup A: APRV group (30 Patients) Post operatively, Patients will be ventilated with APRV mode using GE Carescape R860 ventilator Initial Settings15 1. P high at the P plateau (or desired P mean + 3cm H2O). keep P high below 30-35 cm H2O 2. T high at 4-6 seconds 3. P low at 0 4. T low at 0.5 to 0.8 seconds. 5. ATC (automatic tube compensation) on. 6. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of APRV will start as following, P-High will be lowered 2 or 3 cm of H2O pressure at a time, and T Low will be lengthened in 0.5-2.0 s increments, depending on patient tolerance. When the P-high reaches 10 cmH2O and the Thigh reaches 12-15 seconds, change the mode to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation. |
| Standard group | Active comparator | Device: Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control modeGroup B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode using GE Carescape R860 ventilator Initial Settings: 16 1. Tidal Volume 6-8 ml/kg predicted body weight 2. Respiratory rate (RR) 14 /min 3. Positive end expiratory pressure (PEEP)= 5 cmH2o 4. Pressure Support (PS) = 10 cmH2o 5. Inspiratory time 1.4 Sec 6. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 y.
- Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
- Class III Obesity (Morbid obesity): BMI ≥ 40.0 kg/m².
Key exclusion criteria (4 listed)
- Patients with obstructive lung disease (asthma or chronic obstructive pulmonary disease).
- Pneumothorax or Surgical emphysema.
- Mechanical ventilation prior to the operation.
- Patient Refusal.
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 |
|---|---|---|
| Use Of APRV mode of VentilationPost operatively, Patients will be ventilated with APRV mode using GE Carescape R860 ventilator Initial Settings15 1. P high at the P plateau (or desired P mean + 3cm H2O). keep P high below 30-35 cm H2O 2. T high at 4-6 seconds 3. P low at 0 4. T low at 0.5 to 0.8 seconds. 5. ATC (automatic tube compensation) on. 6. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of APRV will start as following, P-High will be lowered 2 or 3 cm of H2O pressure at a time, and T Low will be lengthened in 0.5-2.0 s increments, depending on patient tolerance. When the P-high reaches 10 cmH2O and the Thigh reaches 12-15 seconds, change the mode to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation. | Device | APRV group |
| Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control modePost-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode using GE Carescape R860 ventilator Initial Settings: 16 1. Tidal Volume 6-8 ml/kg predicted body weight 2. Respiratory rate (RR) 14 /min 3. Positive end expiratory pressure (PEEP)= 5 cmH2o 4. Pressure Support (PS) = 10 cmH2o 5. Inspiratory time 1.4 Sec 6. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of mechanical ventilation will be done by switching the ventilation to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation. | Device | Standard group |
Primary outcome
PO2/FIO2 (P/F) ratio
Time frame: up to 3 days
Will be recorded at admission, 6 hours,12 hours, 24 hours and 48 hours
Time of mechanical ventilation
Time frame: up to 3 days
Hours of Mechanical ventilation
7 secondary outcomes
Need for Non-Invasive ventilation (NIV)
Time frame: up to 3 days
Occurrence Respiratory complications
Time frame: up to 1 week
Effect on Blood pressure
Time frame: up to 1 day
Need for Vasopressors and Inotropes
Time frame: up to 1 day
length of ICU stay
Time frame: up to 3 days
length of Hospital stay
Time frame: up to 10 days
Mortality
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 17383347Villavicencio MA, Sundt TM 3rd, Daly RC, Dearani JA, McGregor CG, Mullany CJ, Orszulak TA, Puga FJ, Schaff HV. Cardiac surgery in patients with body mass index of 50 or greater. Ann Thorac Surg. 2007 Apr;83(4):1403-11. doi: 10.1016/j.athoracsur.2006.10.076.
- Background: PubMed 24709952Ranucci M, Ballotta A, La Rovere MT, Castelvecchio S; Surgical and Clinical Outcome Research (SCORE) Group. Postoperative hypoxia and length of intensive care unit stay after cardiac surgery: the underweight paradox? PLoS One. 2014 Apr 7;9(4):e93992. doi: 10.1371/journal.pone.0093992. eCollection 2014.
- Background: PubMed 24244331Neves FH, Carmona MJ, Auler JO Jr, Rodrigues RR, Rouby JJ, Malbouisson LM. Cardiac compression of lung lower lobes after coronary artery bypass graft with cardiopulmonary bypass. PLoS One. 2013 Nov 11;8(11):e78643. doi: 10.1371/journal.pone.0078643. eCollection 2013.
- Background: PubMed 19727373Daoud EG. Airway pressure release ventilation. Ann Thorac Med. 2007 Oct;2(4):176-9. doi: 10.4103/1817-1737.36556.
- Background: PubMed 34149459Ge H, Lin L, Xu Y, Xu P, Duan K, Pan Q, Ying K. Airway Pressure Release Ventilation Mode Improves Circulatory and Respiratory Function in Patients After Cardiopulmonary Bypass, a Randomized Trial. Front Physiol. 2021 Jun 3;12:684927. doi: 10.3389/fphys.2021.684927. eCollection 2021.
- Background: PubMed 23461947Testerman GM, Breitman I, Hensley S. Airway pressure release ventilation in morbidly obese surgical patients with acute lung injury and acute respiratory distress syndrome. Am Surg. 2013 Mar;79(3):242-6.
- Background: PubMed 11511336Kaplan LJ, Bailey H, Formosa V. Airway pressure release ventilation increases cardiac performance in patients with acute lung injury/adult respiratory distress syndrome. Crit Care. 2001 Aug;5(4):221-6. doi: 10.1186/cc1027. Epub 2001 Jul 2.
- Background: PubMed 30919705Bonatti G, Robba C, Ball L, Silva PL, Rocco PRM, Pelosi P. Controversies when using mechanical ventilation in obese patients with and without acute distress respiratory syndrome. Expert Rev Respir Med. 2019 May;13(5):471-479. doi: 10.1080/17476348.2019.1599285. Epub 2019 Apr 5.
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- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use Of APRV mode of Ventilation in people with Pulmonary Atelectasis and Morbid Obesity, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 4 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 4 Jan 2023. 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 Egypt. 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 Mohamed A. Alhadidy, MD (+201005092648, Mohamed_alaaeldin@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PO2/FIO2 (P/F) ratio (time frame: up to 3 days). The study lists 2 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 NCT05670483, which also lists 15 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 4 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.