Morbid Obesity in Cardiac Surgery PatientsAPRV-OBESE-CSNCT07409324
Prophylactic Use of APRV Before Extubation in Morbidly Obese Patients After Cardiac Surgery.
A study testing Airway Pressure Release Ventilation (APRV) and Conventional Lung-Protective Mechanical Ventilation in people with Morbid Obesity in Cardiac Surgery Patients and Postoperative Respiratory Dysfunction, run by Ain Shams University.
Trial summary
Morbidly obese patients undergoing open heart surgery are at increased risk of breathing problems after removal of the breathing tube due to reduced lung function and chest wall restriction following surgery. These complications may result in poor oxygenation, respiratory failure, and prolonged ICU stay. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity in Cardiac Surgery Patients, Postoperative Respiratory Dysfunction, Mechanical Ventilation Strategies
- What is being tested?
- Airway Pressure Release Ventilation (APRV) and Conventional Lung-Protective Mechanical Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-65 year of both sex.
- Morbidly obese patients (body mass index ≥ 40 kg/m² or ≥ 35 kg/m² with obesity-related comorbidities)
- Scheduled for elective cardiac surgery (CABG, valve, or combined) requiring cardiopulmonary bypass
- Planned postoperative admission to the cardiac surgical intensive care unit
- Patients eligible for mechanical ventilation with planned early extubation within 6-12 hours postoperatively
- Ability to provide written informed consent
Who cannot join
- Severe pulmonary disease (e.g., COPD GOLD III/IV, home oxygen therapy, and pulmonary fibrosis).
- Patients with history of previous spontaneous pneumothorax or postoperative pneumothorax.
- Intracranial hypertension or contraindication to APRV. Hemodynamically unstable on admission (MAP less than 65 mmHg) Vasopressor/inotropic score (VIS) more than 10 Requirement for postoperative extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP).
- Inability to obtain informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prophylactic Use of Airway Pressure Release Ventilation (APRV) Prior to Extubation in Morbidly Obese Patients Undergoing Elective Cardiac Surgery: Impact on Pulmonary Function, Oxygenation, and ICU Outcomes.
Morbidly obese patients undergoing open heart surgery are at increased risk of breathing problems after removal of the breathing tube due to reduced lung function and chest wall restriction following surgery. These complications may result in poor oxygenation, respiratory failure, and prolonged ICU stay.
Airway Pressure Release Ventilation (APRV) is a mechanical ventilation mode that improves lung recruitment and oxygenation. This study aims to evaluate whether the prophylactic use of APRV after ICU admission, compared with conventional lung-protective mechanical ventilation, improves oxygenation, lung function, and ICU outcomes in morbidly obese patients undergoing elective cardiac surgery.
Patients will be randomly assigned to receive either APRV or conventional ventilation during postoperative mechanical ventilation, followed by standard weaning and extubation. Outcomes include oxygenation index, lung ultrasound findings, need for reintubation, and ICU clinical outcomes.
Read the detailed description
Morbid obesity is increasingly prevalent among patients undergoing elective cardiac surgery and is associated with significant postoperative respiratory morbidity. Reduced functional residual capacity, impaired chest wall compliance, atelectasis, and diaphragmatic dysfunction are further exacerbated by median sternotomy, cardiopulmonary bypass, and postoperative pain. These factors increase the risk of hypoxemia, difficult weaning from mechanical ventilation, extubation failure, and prolonged intensive care unit (ICU) stay in this high-risk population.
Conventional postoperative mechanical ventilation strategies in obese cardiac surgery patients typically rely on lung-protective volume-controlled ventilation with moderate to high positive end-expiratory pressure (PEEP). However, despite these strategies, postoperative atelectasis and impaired oxygenation remain common, particularly in morbidly obese patients.
Airway Pressure Release Ventilation (APRV) is a pressure-controlled mode of ventilation characterized by prolonged periods of high continuous airway pressure with brief release phases, allowing spontaneous breathing throughout the ventilatory cycle. APRV has been shown to improve alveolar recruitment, ventilation-perfusion matching, and oxygenation while limiting alveolar collapse and reducing atelectrauma. Its physiological advantages suggest a potential role in preventing postoperative pulmonary complications when applied early in the ICU course.
This randomized controlled study aims to evaluate the prophylactic application of APRV initiated upon ICU admission, compared with conventional lung-protective mechanical ventilation, in morbidly obese patients undergoing elective cardiac surgery. Mechanical ventilation will be applied according to group allocation until patients meet predefined criteria for extubation. Prior to extubation, both groups will be transitioned to standardized spontaneous breathing trials using continuous positive airway pressure (CPAP) or pressure support ventilation.
The primary outcome of the study is oxygenation index measured at predefined time points, including on ICU admission, immediately prior to extubation, and after extubation. Secondary outcomes include lung ultrasound score, incidence of reintubation, duration of mechanical ventilation, ICU length of stay, postoperative pulmonary complications, and hemodynamic stability.
By focusing on early postoperative ventilation strategy rather than rescue therapy, this study seeks to determine whether prophylactic APRV can improve respiratory physiology and clinical outcomes in morbidly obese patients following elective cardiac surgery.
- Conditions
- Morbid Obesity in Cardiac Surgery Patients, Postoperative Respiratory Dysfunction, Mechanical Ventilation Strategies
- Being tested
- Airway Pressure Release Ventilation (APRV), Conventional Lung-Protective Mechanical Ventilation
- Keywords
- Airway Pressure Release Ventilation, Morbid Obesity, Cardiac Surgery, Postoperative Ventilation, Lung Ultrasound, Oxygenation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Pressure Release Ventilation (APRV)Device
Also called APRV
Patients will be ventilated using the Airway Pressure Release Ventilation (APRV) mode immediately upon ICU admission. This mode will be maintained throughout the postoperative period until the patient meets the clinical criteria for extubation. with the following standardized steps:
Initial APRV Settings
- P High: 20-25 cm H₂O
- P Low: 0 cm H₂O
- T High: 4.0-6.0 seconds
- T Low: 0.5-0.8 seconds
- FiO₂: Adjusted to maintain SpO₂ >92% Note: P High may be titrated according to patient tolerance, Mean airway pressure (MAP), and plateau pressures. T Low is set to terminate expiratory flow at 50-75% to preserve lung recruitment.
Weaning/Transition from APRV to Extubation Once oxygenation and ventilation criteria are met:
- T High will be gradually increased (to ≥8 sec) and P High decreased (to 10-15 cm H₂O)
- Then transition to CPAP/PS for 15-30 minutes Final decision for extubation will be based on successful spontaneous breathing trial (SBT) (RSBI < 105) and clinical readiness
Conventional Lung-Protective Mechanical VentilationDevice
Also called SIMV Volume-Controlled Ventilation
Patients will be ventilated using the SIMV Volume-Controlled mode with lung-protective strategies:
- Tidal volume: 6-8 mL/kg of Ideal Body Weight (IBW)
- PEEP: Set at 8-12 cm H₂O, individualized based on oxygenation status
- Respiratory rate: Adjusted to maintain normocapnia, typically starting from 12-18 breaths per minute
- FiO₂: Titrated to maintain SpO₂ > 92%
- Also transition to CPAP/PS for 15-30 minutes as a transition before extubation will be applied.
| Study group | Role | What they receive |
|---|---|---|
| APRV Ventilation Strategy Group | Experimental | Intervention Name: Airway Pressure Release Ventilation (APRV) Patients will receive airway pressure release ventilation immediately upon admission to the intensive care unit following elective cardiac surgery. APRV will be applied as the primary ventilatory mode until the patient fulfills predefined extubation readiness criteria. Prior to extubation, patients will be transitioned to continuous positive airway pressure (CPAP) with pressure support or a T-piece trial for 15-30 minutes according to ICU protocol. Receives: Device: Airway Pressure Release Ventilation (APRV) |
| Conventional Lung-Protective Ventilation Group | Active comparator | Patients will receive conventional lung-protective mechanical ventilation using synchronized intermittent mandatory ventilation (SIMV) in volume-controlled mode with a tidal volume of 6-8 mL/kg of ideal body weight and high positive end-expiratory pressure upon admission to the intensive care unit. Ventilation will be continued until extubation readiness criteria are met, followed by a CPAP with pressure support or T-piece trial for 15-30 minutes prior to extubation. Receives: Device: Conventional Lung-Protective Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation Index (OI)
The oxygenation index will be used as a quantitative measure of pulmonary oxygenation efficiency. It will be calculated using the formula:
OI = (Mean Airway Pressure × FiO₂ × 100) / PaO₂. Changes in oxygenation index will be assessed to compare the effect of prophylactic APRV versus conventional lung-protective ventilation on pulmonary function in morbidly obese patients after elective cardiac surgery.
Measured: o Immediately before APRV initiation o 1 hour before extubation o 1 hour post-extubation o 6 hours post extubation o 24 hours post extubation
Secondary outcomes (7)
Lung Ultrasound Score (LUS)
Lung aeration will be assessed using lung ultrasound scoring across standardized thoracic zones. Each zone will be graded based on the presence of A-lines, B-lines, or consolidation, with higher scores indicating worse aeration. The lung ultrasound score will be used to evaluate postoperative lung recruitment and aeration in both study groups.
Measured: o 1 hour before extubation o 6 hours post extubation
PaO₂/FiO₂ Ratio
The PaO₂/FiO₂ ratio will be measured as an indicator of oxygenation efficiency and gas exchange. Higher values indicate improved pulmonary oxygenation.
Measured: o Immediately before APRV initiation o 1 hour before extubation o 1 hour post-extubation o 6 hours post extubation o 24 hours post extubation
Reintubation Rate
Reintubation will be defined as the need for endotracheal intubation within 48 hours following planned extubation due to predefined clinical criteria including hypoxemia, hypercapnia, respiratory distress, altered mental status, or hemodynamic instability.
Measured: Within 48 hours after extubation
Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation from ICU admission until successful extubation.
Measured: From ICU admission until successful extubation, assessed up to 24 hours
Incidence of Post-Extubation Pulmonary Complications
Includes:
- Hypoxemia (SpO₂ <90% )
- Use of noninvasive ventilation (NIV) support
- Development of pulmonary edema or new radiographic infiltrates
- Need for rescue bronchodilators or diuretics
Measured: Within 48 hours post-extubation
Number of Participants Requiring Vasopressor or Inotropic Support During APRV
The number of participants who require initiation or escalation of vasopressor or inotropic support to maintain adequate hemodynamics (defined as mean arterial pressure ≥65 mmHg) during and after application of airway pressure release ventilation (APRV).
Measured: From APRV initiation until 24 hours post-extubation
Mean Arterial Pressure During and After APRV
Mean arterial pressure (MAP (mmHg)), measured invasively, will be recorded to assess hemodynamic stability during and after APRV application.
Measured: Immediately before APRV initiation 1 hour before extubation 1 hour post-extubation 3 hours post-extubation 6 hours post-extubation 24 hours post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid Obesity in Cardiac Surgery PatientsStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aya M Abbas, M.B.B.CH., M.Sc, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409324
- Sponsor's protocol ID
- FMASU MD288/2025
- Acronym
- APRV-OBESE-CS
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Airway Pressure Release Ventilation (APRV) Prior to Extubation in Morbidly Obese Patients Undergoing Elective Cardiac Surgery: Impact on Pulmonary Function, Oxygenation, and ICU Outcomes.
- ClinicalTrials.gov ID
- NCT07409324
- Acronym / sponsor ID
- APRV-OBESE-CS / FMASU MD288/2025
- Conditions
- Morbid Obesity in Cardiac Surgery Patients, Postoperative Respiratory Dysfunction, Mechanical Ventilation Strategies
- Keywords
- Airway Pressure Release Ventilation, Morbid Obesity, Cardiac Surgery, Postoperative Ventilation, Lung Ultrasound, Oxygenation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
Morbidly obese patients undergoing open heart surgery are at increased risk of breathing problems after removal of the breathing tube due to reduced lung function and chest wall restriction following surgery. These complications may result in poor oxygenation, respiratory failure, and prolonged ICU stay.
Airway Pressure Release Ventilation (APRV) is a mechanical ventilation mode that improves lung recruitment and oxygenation. This study aims to evaluate whether the prophylactic use of APRV after ICU admission, compared with conventional lung-protective mechanical ventilation, improves oxygenation, lung function, and ICU outcomes in morbidly obese patients undergoing elective cardiac surgery.
Patients will be randomly assigned to receive either APRV or conventional ventilation during postoperative mechanical ventilation, followed by standard weaning and extubation. Outcomes include oxygenation index, lung ultrasound findings, need for reintubation, and ICU clinical outcomes.
Detailed description
Morbid obesity is increasingly prevalent among patients undergoing elective cardiac surgery and is associated with significant postoperative respiratory morbidity. Reduced functional residual capacity, impaired chest wall compliance, atelectasis, and diaphragmatic dysfunction are further exacerbated by median sternotomy, cardiopulmonary bypass, and postoperative pain. These factors increase the risk of hypoxemia, difficult weaning from mechanical ventilation, extubation failure, and prolonged intensive care unit (ICU) stay in this high-risk population.
Conventional postoperative mechanical ventilation strategies in obese cardiac surgery patients typically rely on lung-protective volume-controlled ventilation with moderate to high positive end-expiratory pressure (PEEP). However, despite these strategies, postoperative atelectasis and impaired oxygenation remain common, particularly in morbidly obese patients.
Airway Pressure Release Ventilation (APRV) is a pressure-controlled mode of ventilation characterized by prolonged periods of high continuous airway pressure with brief release phases, allowing spontaneous breathing throughout the ventilatory cycle. APRV has been shown to improve alveolar recruitment, ventilation-perfusion matching, and oxygenation while limiting alveolar collapse and reducing atelectrauma. Its physiological advantages suggest a potential role in preventing postoperative pulmonary complications when applied early in the ICU course.
This randomized controlled study aims to evaluate the prophylactic application of APRV initiated upon ICU admission, compared with conventional lung-protective mechanical ventilation, in morbidly obese patients undergoing elective cardiac surgery. Mechanical ventilation will be applied according to group allocation until patients meet predefined criteria for extubation. Prior to extubation, both groups will be transitioned to standardized spontaneous breathing trials using continuous positive airway pressure (CPAP) or pressure support ventilation.
The primary outcome of the study is oxygenation index measured at predefined time points, including on ICU admission, immediately prior to extubation, and after extubation. Secondary outcomes include lung ultrasound score, incidence of reintubation, duration of mechanical ventilation, ICU length of stay, postoperative pulmonary complications, and hemodynamic stability.
By focusing on early postoperative ventilation strategy rather than rescue therapy, this study seeks to determine whether prophylactic APRV can improve respiratory physiology and clinical outcomes in morbidly obese patients following elective cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APRV Ventilation Strategy Group | Experimental | Device: Airway Pressure Release Ventilation (APRV)Intervention Name: Airway Pressure Release Ventilation (APRV) Patients will receive airway pressure release ventilation immediately upon admission to the intensive care unit following elective cardiac surgery. APRV will be applied as the primary ventilatory mode until the patient fulfills predefined extubation readiness criteria. Prior to extubation, patients will be transitioned to continuous positive airway pressure (CPAP) with pressure support or a T-piece trial for 15-30 minutes according to ICU protocol. |
| Conventional Lung-Protective Ventilation Group | Active comparator | Device: Conventional Lung-Protective Mechanical VentilationPatients will receive conventional lung-protective mechanical ventilation using synchronized intermittent mandatory ventilation (SIMV) in volume-controlled mode with a tidal volume of 6-8 mL/kg of ideal body weight and high positive end-expiratory pressure upon admission to the intensive care unit. Ventilation will be continued until extubation readiness criteria are met, followed by a CPAP with pressure support or T-piece trial for 15-30 minutes prior to extubation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients aged 18-65 year of both sex.
- Morbidly obese patients (body mass index ≥ 40 kg/m² or ≥ 35 kg/m² with obesity-related comorbidities)
- Scheduled for elective cardiac surgery (CABG, valve, or combined) requiring cardiopulmonary bypass
- Planned postoperative admission to the cardiac surgical intensive care unit
- Patients eligible for mechanical ventilation with planned early extubation within 6-12 hours postoperatively
Key exclusion criteria (4 listed)
- Severe pulmonary disease (e.g., COPD GOLD III/IV, home oxygen therapy, and pulmonary fibrosis).
- Patients with history of previous spontaneous pneumothorax or postoperative pneumothorax.
- Intracranial hypertension or contraindication to APRV. Hemodynamically unstable on admission (MAP less than 65 mmHg) Vasopressor/inotropic score (VIS) more than 10 Requirement for postoperative extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP).
- Inability to obtain informed consent
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 |
|---|---|---|
| Airway Pressure Release Ventilation (APRV)Also: APRVPatients will be ventilated using the Airway Pressure Release Ventilation (APRV) mode immediately upon ICU admission. This mode will be maintained throughout the postoperative period until the patient meets the clinical criteria for extubation. with the following standardized steps: Initial APRV Settings * P High: 20-25 cm H₂O * P Low: 0 cm H₂O * T High: 4.0-6.0 seconds * T Low: 0.5-0.8 seconds * FiO₂: Adjusted to maintain SpO₂ >92% Note: P High may be titrated according to patient tolerance, Mean airway pressure (MAP), and plateau pressures. T Low is set to terminate expiratory flow at 50-75% to preserve lung recruitment. Weaning/Transition from APRV to Extubation Once oxygenation and ventilation criteria are met: * T High will be gradually increased (to ≥8 sec) and P High decreased (to 10-15 cm H₂O) * Then transition to CPAP/PS for 15-30 minutes Final decision for extubation will be based on successful spontaneous breathing trial (SBT) (RSBI < 105) and clinical readiness | Device | APRV Ventilation Strategy Group |
| Conventional Lung-Protective Mechanical VentilationAlso: SIMV Volume-Controlled VentilationPatients will be ventilated using the SIMV Volume-Controlled mode with lung-protective strategies: * Tidal volume: 6-8 mL/kg of Ideal Body Weight (IBW) * PEEP: Set at 8-12 cm H₂O, individualized based on oxygenation status * Respiratory rate: Adjusted to maintain normocapnia, typically starting from 12-18 breaths per minute * FiO₂: Titrated to maintain SpO₂ > 92% * Also transition to CPAP/PS for 15-30 minutes as a transition before extubation will be applied. | Device | Conventional Lung-Protective Ventilation Group |
Primary outcome
Oxygenation Index (OI)
Time frame: o Immediately before APRV initiation o 1 hour before extubation o 1 hour post-extubation o 6 hours post extubation o 24 hours post extubation
The oxygenation index will be used as a quantitative measure of pulmonary oxygenation efficiency. It will be calculated using the formula: OI = (Mean Airway Pressure × FiO₂ × 100) / PaO₂. Changes in oxygenation index will be assessed to compare the effect of prophylactic APRV versus conventional lung-protective ventilation on pulmonary function in morbidly obese patients after elective cardiac surgery.
7 secondary outcomes
Lung Ultrasound Score (LUS)
Time frame: o 1 hour before extubation o 6 hours post extubation
PaO₂/FiO₂ Ratio
Time frame: o Immediately before APRV initiation o 1 hour before extubation o 1 hour post-extubation o 6 hours post extubation o 24 hours post extubation
Reintubation Rate
Time frame: Within 48 hours after extubation
Duration of Mechanical Ventilation
Time frame: From ICU admission until successful extubation, assessed up to 24 hours
Incidence of Post-Extubation Pulmonary Complications
Time frame: Within 48 hours post-extubation
Number of Participants Requiring Vasopressor or Inotropic Support During APRV
Time frame: From APRV initiation until 24 hours post-extubation
Mean Arterial Pressure During and After APRV
Time frame: Immediately before APRV initiation 1 hour before extubation 1 hour post-extubation 3 hours post-extubation 6 hours post-extubation 24 hours post-extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
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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.
Aya M Abbas, M.B.B.CH., M.Sc principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Airway Pressure Release Ventilation (APRV) and Conventional Lung-Protective Mechanical Ventilation in people with Morbid Obesity in Cardiac Surgery Patients and Postoperative Respiratory Dysfunction, run by Ain Shams University.
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 6 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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya M Abbas, M.B.B.CH., M.Sc (+201157115835 ext. +201157115835, ayaaabbass75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation Index (OI) (time frame: o Immediately before APRV initiation o 1 hour before extubation o 1 hour post-extubation o 6 hours post extubation o 24 hours post extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.