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NCT Number: NCT07409324

Prophylactic Use of APRV Before Extubation in Morbidly Obese Patients After Cardiac Surgery.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Airway Pressure Release Ventilation (APRV)

Device

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

Other names: APRV

Conventional Lung-Protective Mechanical Ventilation

Device

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.

Other names: SIMV Volume-Controlled Ventilation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Lung Ultrasound Score (LUS)

    Time frame: o 1 hour before extubation o 6 hours post extubation

    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.

  2. 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

    The PaO₂/FiO₂ ratio will be measured as an indicator of oxygenation efficiency and gas exchange. Higher values indicate improved pulmonary oxygenation.

  3. Reintubation Rate

    Time frame: Within 48 hours after extubation

    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.

  4. Duration of Mechanical Ventilation

    Time frame: From ICU admission until successful extubation, assessed up to 24 hours

    Total duration of invasive mechanical ventilation from ICU admission until successful extubation.

  5. Incidence of Post-Extubation Pulmonary Complications

    Time frame: Within 48 hours post-extubation

    Includes:

    • Hypoxemia (SpO₂ <90% )
    • Use of noninvasive ventilation (NIV) support
    • Development of pulmonary edema or new radiographic infiltrates
    • Need for rescue bronchodilators or diuretics
  6. Number of Participants Requiring Vasopressor or Inotropic Support During APRV

    Time frame: From APRV initiation until 24 hours post-extubation

    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).

  7. 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

    Mean arterial pressure (MAP (mmHg)), measured invasively, will be recorded to assess hemodynamic stability during and after APRV application.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya M Abbas, M.B.B.CH., M.Sc

CONTACT

[email protected]

+201157115835 ext. +201157115835

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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.

Acronym: APRV-OBESE-CS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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