An interventional study of Driving Pressure-Guided Individualized PEEP and Standard PEEP in Postoperative Pulmonary Complications and Mechanical Ventilation, sponsored by Hopital Charles Nicolle. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Hopital Charles Nicolle · Not applicable, Interventional, and Prevention
This randomized clinical trial compares two methods of setting positive end-expiratory pressure (PEEP) during general anesthesia in adults undergoing upper abdominal digestive surgery who are at moderate or high risk of postoperative pulmonary complications.
All participants will receive lung-protective mechanical ventilation. Participants will be randomly assigned to one of two groups. In the individualized PEEP group, PEEP will be adjusted to achieve the lowest driving pressure following a lung recruitment maneuver. In the standard PEEP group, PEEP will be fixed at 5 cmH2O.
The main question is whether driving pressure-guided individualized PEEP reduces the proportion of participants who develop one or more postoperative pulmonary complications during the first 7 days after surgery compared with standard PEEP.
Postoperative pulmonary complications are common after upper abdominal surgery and can increase postoperative morbidity and length of hospital stay. Although positive end-expiratory pressure may help prevent alveolar collapse during general anesthesia, a fixed PEEP level may be insufficient for some patients and excessive for others.
Driving pressure is calculated as plateau pressure minus PEEP and reflects the pressure required to deliver the tidal volume to the respiratory system. Individualizing PEEP according to the lowest driving pressure may improve respiratory-system compliance while limiting both alveolar collapse and overdistension.
In this prospective, randomized, controlled, parallel-group trial, eligible participants will be randomly allocated in a 1:1 ratio to either driving pressure-guided individualized PEEP or standard PEEP. In the individualized PEEP group, a lung recruitment maneuver will be followed by a decremental PEEP trial. The PEEP level associated with the lowest driving pressure will be selected, provided that adequate oxygenation and hemodynamic stability are maintained. In the standard PEEP group, PEEP will be maintained at 5 cmH2O. All other aspects of lung-protective ventilation and perioperative care will be standardized between the groups.
Participants and the independent postoperative outcome assessor will remain unaware of treatment allocation. Postoperative pulmonary complications will be assessed from the day of surgery through postoperative day 7.
Hopital Charles Nicolle is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a lung recruitment maneuver followed by a decremental PEEP trial. The PEEP level associated with the lowest driving pressure is selected, provided that adequate oxygenation and hemodynamic stability are maintained.
Procedure: Driving Pressure-Guided Individualized PEEP
Participants receive lung-protective mechanical ventilation with a fixed PEEP of 5 cmH2O throughout the intraoperative ventilation period.
Procedure: Standard PEEP
Participants assigned to this experimental arm receive a lung recruitment maneuver followed by a decremental PEEP trial. Driving pressure is calculated as plateau pressure minus PEEP at each tested level. The PEEP associated with the lowest driving pressure is selected and maintained during surgery, provided that adequate oxygenation and hemodynamic stability are preserved.
Participants receive lung-protective mechanical ventilation with PEEP fixed at 5 cmH2O throughout the intraoperative ventilation period. The other components of perioperative ventilation and care are standardized between the two groups.
postoperative pulmonary complications
Incidence of postoperative pulmonary complications occurring within the first 7 postoperative days, according to the study-defined criteria.
Time frame: From the end of surgery through postoperative day 7 (up to 7 days)
Length of hospital stay
Length of hospital stay will be calculated as the number of days from the date of surgery to the date of hospital discharge.
Time frame: From the day of surgery through hospital discharge, assessed up to 30 days after surgery.
Postoperative Intensive Care Unit Admission
Number and percentage of participants requiring admission to an intensive care unit after surgery.
Time frame: From the end of surgery through hospital discharge, assessed up to 30 days after surgery.
Intensive Care Unit Length of Stay
Among participants admitted to the intensive care unit, length of stay measured in calendar days from intensive care unit admission to intensive care unit discharge.
Time frame: At intensive care unit discharge, assessed up to 30 days after surgery.
Intraoperative Tidal Volume
Tidal volume delivered during mechanical ventilation, expressed in mL/kg of ideal body weight and recorded at predefined intraoperative time points.
Time frame: 10 minutes after tracheal intubation; 1, 2, and 3 hours after intubation; and at the end of surgery.
Median Intraoperative Positive End-Expiratory Pressure
Median positive end-expiratory pressure (PEEP) applied during intraoperative mechanical ventilation, expressed in cmH2O and calculated from values recorded at the predefined intraoperative assessment points.
Time frame: 10 minutes after tracheal intubation; 1, 2, and 3 hours after intubation; and at the end of surgery.
Intraoperative Peak Airway Pressure
Peak airway pressure measured during intraoperative mechanical ventilation, expressed in cmH2O.
Time frame: 10 minutes after tracheal intubation; 1, 2, and 3 hours after intubation; and at the end of surgery.
Intraoperative Plateau Pressure
Plateau pressure measured during an end-inspiratory occlusion lasting 2 to 3 seconds, expressed in cmH2O.
Time frame: From initiation of mechanical ventilation after tracheal intubation through the end of surgery
Intraoperative Static Respiratory System Compliance
Static respiratory system compliance calculated as tidal volume divided by the difference between plateau pressure and positive end-expiratory pressure, expressed in mL/cmH2O.
Time frame: From initiation of mechanical ventilation after tracheal intubation through the end of surgery
Intraoperative Dynamic Respiratory System Compliance
Dynamic respiratory system compliance calculated as tidal volume divided by the difference between peak airway pressure and positive end-expiratory pressure, expressed in mL/cmH2O.
Time frame: From initiation of mechanical ventilation after tracheal intubation through the end of surgery
Intraoperative Systolic Arterial Pressure
Systolic arterial pressure measured every 5 minutes during surgery and expressed in mmHg.
Time frame: From anesthetic induction through the end of surgery
Intraoperative Diastolic Arterial Pressure
Diastolic arterial pressure measured every 5 minutes during surgery and expressed in mmHg.
Time frame: From anesthetic induction through the end of surgery
Intraoperative Mean Arterial Pressure
Mean arterial pressure measured every 5 minutes during surgery and expressed in mmHg.
Time frame: From anesthetic induction through the end of surgery
Intraoperative Heart Rate
Heart rate measured continuously and recorded every 5 minutes during surgery, expressed in beats per minute.
Time frame: From anesthetic induction through the end of surgery
Postoperative Intensive Care Unit Admission
Number and percentage of participants requiring admission to an intensive care unit after surgery.
Time frame: From the end of surgery until hospital discharge, assessed up to 30 days postoperatively.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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