Postoperative Pulmonary ComplicationsNCT07885124
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
A study testing Driving Pressure-Guided Individualized PEEP and Standard PEEP in people with Postoperative Pulmonary Complications and Mechanical Ventilation, run by Hopital Charles Nicolle at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications, Mechanical Ventilation
- What is being tested?
- Driving Pressure-Guided Individualized PEEP and Standard PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTunisia
- Study dates
- 22 May 2026to 22 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Scheduled for supra-mesocolic upper abdominal digestive surgery.
- American Society of Anesthesiologists (ASA) physical status I, II, or stable III.
- Moderate or high risk of postoperative pulmonary complications, defined by an Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score of 26 or higher.
- Provision of written informed consent.
Who cannot join
- Refusal to participate or inability to provide written informed consent.
- Pregnancy.
- ASA physical status greater than III.
- History of acute respiratory distress syndrome.
- Pulmonary hypertension.
- Bronchopleural fistula.
Show all 11Show fewer
- Chronic obstructive pulmonary disease with severe emphysema.
- Pre-existing cardiac arrhythmia.
- Decompensated heart failure.
- Known condition associated with increased intracranial pressure.
- Intra-abdominal hypertension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Charles Nicole Hospital
Tunis, 2068
Hallouma Ben Fredj, MD, 25207433, hallouma.benfredj@fmt.utm.tn
About this study
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.
Read the detailed description
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.
- Being tested
- Driving Pressure-Guided Individualized PEEP, Standard PEEP
- Keywords
- Driving Pressure, Individualized PEEP, Positive End-Expiratory Pressure, PEEP Titration, Lung Recruitment Maneuver, Lung-Protective Ventilation, Upper Abdominal Surgery, ARISCAT Score, Perioperative Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving Pressure-Guided Individualized PEEPProcedure or surgery
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.
Standard PEEPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Driving Pressure-Guided Individualized PEEP | Experimental | 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. Receives: Procedure: Driving Pressure-Guided Individualized PEEP |
| Standard PEEP | Active comparator | Participants receive lung-protective mechanical ventilation with a fixed PEEP of 5 cmH2O throughout the intraoperative ventilation period. Receives: Procedure: Standard PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pulmonary complications
Incidence of postoperative pulmonary complications occurring within the first 7 postoperative days, according to the study-defined criteria.
Measured: From the end of surgery through postoperative day 7 (up to 7 days)
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the end of surgery until hospital discharge, assessed up to 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start22 May 2026
- Primary completion22 Jun 2027 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary ComplicationsStudies 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
- Model description
- Two-arm, parallel-group, randomized controlled trial. Participants are assigned in a 1:1 ratio to either driving pressure-guided individualized PEEP or standard PEEP. Each participant remains in the assigned group throughout the intraoperative intervention, with no crossover between groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Charles Nicolle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jebri alia, Hopital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885124
- Sponsor's protocol ID
- CharlesNicolle Hospital
- Status last verified
- May 2026
- First submitted
- 3 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
PubMed 24894577
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
- ClinicalTrials.gov ID
- NCT07885124
- Acronym / sponsor ID
- CharlesNicolle Hospital
- Keywords
- Driving Pressure, Individualized PEEP, Positive End-Expiratory Pressure, PEEP Titration, Lung Recruitment Maneuver, Lung-Protective Ventilation, Upper Abdominal Surgery, ARISCAT Score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hopital Charles NicolleUniversity, hospital or other
- Study start
- 22 May 2026 (actual)
- Primary completion
- 22 Jun 2027 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 21 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, randomized controlled trial. Participants are assigned in a 1:1 ratio to either driving pressure-guided individualized PEEP or standard PEEP. Each participant remains in the assigned group throughout the intraoperative intervention, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Driving Pressure-Guided Individualized PEEP | Experimental | Procedure: Driving Pressure-Guided Individualized PEEPParticipants 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. |
| Standard PEEP | Active comparator | Procedure: Standard PEEPParticipants receive lung-protective mechanical ventilation with a fixed PEEP of 5 cmH2O throughout the intraoperative ventilation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Scheduled for supra-mesocolic upper abdominal digestive surgery.
- American Society of Anesthesiologists (ASA) physical status I, II, or stable III.
- Moderate or high risk of postoperative pulmonary complications, defined by an Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score of 26 or higher.
- Provision of written informed consent.
Key exclusion criteria (11 listed)
- Refusal to participate or inability to provide written informed consent.
- Pregnancy.
- ASA physical status greater than III.
- History of acute respiratory distress syndrome.
- Pulmonary hypertension.
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 |
|---|---|---|
| Driving Pressure-Guided Individualized PEEPParticipants 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. | Procedure or surgery | Driving Pressure-Guided Individualized PEEP |
| Standard PEEPParticipants 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. | Procedure or surgery | Standard PEEP |
Primary outcome
postoperative pulmonary complications
Time frame: From the end of surgery through postoperative day 7 (up to 7 days)
Incidence of postoperative pulmonary complications occurring within the first 7 postoperative days, according to the study-defined criteria.
14 secondary outcomes
Length of hospital stay
Time frame: From the day of surgery through hospital discharge, assessed up to 30 days after surgery.
Postoperative Intensive Care Unit Admission
Time frame: From the end of surgery through hospital discharge, assessed up to 30 days after surgery.
Intensive Care Unit Length of Stay
Time frame: At intensive care unit discharge, assessed up to 30 days after surgery.
Intraoperative Tidal Volume
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
Time frame: 10 minutes after tracheal intubation; 1, 2, and 3 hours after intubation; and at the end of surgery.
Intraoperative Peak Airway Pressure
Time frame: 10 minutes after tracheal intubation; 1, 2, and 3 hours after intubation; and at the end of surgery.
Intraoperative Plateau Pressure
Time frame: From initiation of mechanical ventilation after tracheal intubation through the end of surgery
Intraoperative Static Respiratory System Compliance
Time frame: From initiation of mechanical ventilation after tracheal intubation through the end of surgery
Intraoperative Dynamic Respiratory System Compliance
Time frame: From initiation of mechanical ventilation after tracheal intubation through the end of surgery
Intraoperative Systolic Arterial Pressure
Time frame: From anesthetic induction through the end of surgery
Intraoperative Diastolic Arterial Pressure
Time frame: From anesthetic induction through the end of surgery
Intraoperative Mean Arterial Pressure
Time frame: From anesthetic induction through the end of surgery
Intraoperative Heart Rate
Time frame: From anesthetic induction through the end of surgery
Postoperative Intensive Care Unit Admission
Time frame: From the end of surgery until hospital discharge, assessed up to 30 days postoperatively.
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 21 Oct 2026.
- Background: PubMed 24894577PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving Pressure-Guided Individualized PEEP and Standard PEEP in people with Postoperative Pulmonary Complications and Mechanical Ventilation, run by Hopital Charles Nicolle at 1 site in Tunisia.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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 Tunisia. 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?
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 Hallouma Ben Fredj, MD (25207433, hallouma.benfredj@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pulmonary complications (time frame: From the end of surgery through postoperative day 7 (up to 7 days)). 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 NCT07885124, which also lists 1 linked publication.
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 21 Oct 2026.