An interventional study of PEEP titration for Minimum Driving Pressure and Lung Protective Ventilation in Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Complications and Postoperative Respiratory Failure, sponsored by University General Hospital of Patras. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by University General Hospital of Patras · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to compare two different types of perioperative mechanical ventilation (MV), specifically Protective Mechanical Ventilation (PMV) and MV with the lowest possible Driving Pressure (ΔP), in relation to the appearance of postoperative pulmonary complications (PPCs) in adult patients who are operated and have higher risk of PPCs.
The main questions it aims to answer are:
Researchers will compare MV with the lowest possible Driving Pressure (ΔP) to Protective Mechanical Ventilation (PMV) to see if any of this is more protective than the other concerning PPCs.
All participants will receive perioperative MV.
Half of them will receive conventional Protective Mechanical Ventilation (PMV). This will include well known generally protective settings for mechanical ventilation of patients, concerning volumes, pressures, respiratory rate, inspiratory gases and ventilation maneuvers.
The rest of participants will be ventilated with the lowest possible Driving Pressure (ΔP). This will be similar to PMV in the chosen volumes, respiratory rate, inspiratory gases and ventilation maneuvers. However, the pressure inside lung at the end of expiration, eg Positive End Expiratory Pressure (PEEP), will be not be preset for every patient. Initially, the investigators will perform a maneuver that will quantify each individual's lung characteristics and mechanics. According to this, the investigators will find the exact PEEP that seems to suit each patients lungs most, and use this perioperatively, trying to provide lungs the best conditions every time.
After the completion of the operation, all the patients will be screened for PPCs, via arterial blood testing and chest X ray, and the results will be statistically analyzed trying to find if any of the forementioned strategies of mechanical ventilation surpasses the other concerning PPCs appearance. PPCs include atelectasis, respiratory failure, bronchospasm, pleural effusion, pneumonia, aspiration and pneumothorax.
Furthermore hospital stay, ICU need and mortality will be noted. Finally, measurements of perioperative lung pressures, volumes and derived variables will be noted and compared statistically as well.
377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 268 interventional studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →University General Hospital of Patras is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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CONVENTIONAL LUNG PROTECTIVE VENTILATION This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP 8 cm H20 Tidal Volume (VT) 8 ml/kg Ideal Body Weight (IBW) Respiratory Rate (RR) --\> Arterial Partial CO2 Pressure (PaCO2) = 35-45 mmHg Inspired Oxygen Fracture (FiO2) 0.4 - 0.5 --\> Peripheral Oxygen Saturation (SpO2) \> 93% Recruitment Maneuver (as described) every hour
Procedure: Lung Protective Ventilation
This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP; Initially 8 cm H2. Titrated at level with Minimum Driving Pressure after first recruitment - titration maneuver followed by new recruitment maneuver VT 8 ml/kg IBW RR --\> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --\> SpO2 \> 93% Recruitment Maneuver (as described) every hour
Procedure: PEEP titration for Minimum Driving Pressure
This group is mechanically ventilated with Invasive Mechanical Ventilation with Volume Control Ventilation mode with PEEP Initially 8 cm H2O. Afterwards, the lungs are recruited with the aforementioned maneuver. During subsequent derecruitment, PEEP is decreased by 2 cm H20 and compliance is noted in each stage. The goal is to find PEEP with maximum compliance (Cmax). A new recruitment maneuver follows and during derecruitment PEEP is set at the optimum value that was previously defined. VT 8 ml/kg IBW RR --\> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --\> SpO2 \> 93% Recruitment Maneuver (as described) every hour
Also known as: Maximum compliance mechanical ventilation, Cmax Mechanical Ventilation
This group is mechanically ventilated with Invasive Mechanical Ventilation with Volume Control Ventilation mode with PEEP 8 cm H2O. VT 8 ml/kg IBW RR --\> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --\> SpO2 \> 93% Recruitment Maneuvers (as described) every hour
Postoperative Pulmonary Complications
Number of the following Postoperative Pulmonary Complications 1. Postoperative Atelectasis (based on Chest X-Ray in Post-Anesthesia Care Unit - PACU) 2. Postoperative Respiratory Failure based on Arterial Blood Gases in PACU (type I and/or II) 3. Postoperative Bronchospasm 4. Postoperative Pleural Effusion 5. Postoperative Pneumonia 6. Postoperative Aspiration Pneumonitis 7. Postoperative Postoperative Pneumothorax
Time frame: Atelectasis -> Within 1 hour in PACURespiratory failure -> Immediately postoperatively & after 30 minutes in PACU.Bronchospasm, Pleural Effusion, Pneumonia, Aspiration Pneumonitis, Pneumothorax -> from immediately postoperative until end of study
Hospital Stay
Total hospital stay days from day of operation until hospital discharge.
Time frame: From day of operation until the end of patient stay inside hospital, because of return to home or due to death.
ICU need.
Potential Need for ICU admission.
Time frame: From day of operation until the end of patient stay inside hospital, because of return to home or due to death.
ICU stay
In case of ICU need, total days of ICU stay.
Time frame: From day of operation until the end of patient stay inside hospital, because of return to home or due to death.
28 Day mortality
Incidence of death in 28 days in each group.
Time frame: From day of operation until up to 28 days.
Mechanical Power (MP)
To calculate MP, the following must be recorded: RR, Peak Airway Pressure (Ppeak), Plateau Pressure (Pplat), and PEEP. The simplified equation will be used; MP = 0.098 × RR × \[Ppeak - (Plat-PEEP)/2\]
Time frame: From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation
Volume-normalized Mechanical Power (MPcrs)
MPcrs = MP/Respiratory System Compliance (Crs)
Time frame: From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation
Elastic Power (EP)
To calculate EP, the following must be recorded: RR, VT, Pplat, and PEEP. The following equation will be used: EP = 0.098 × RR × VT × \[(Plat+PEEP)/2\]
Time frame: From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation
Volume-normalized Elastic Power (EPcrs)
EPcrs = EP/Crs
Time frame: From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation
Plan to share: Yes — Excel file per patient containing all the collected data Preoperatively; Patient demographics, ARISCAT score Perioperatively; Mechanical ventilation settings and measurements. Type and duration of operation. Anesthetic methods. Aerial blood gases results. Data from haemodynamic monitoring. Quantity of crystalloids , vasoperessors and inotropes. Postoperatively; Arterial blood gases results in PACU, Potential presence of other postoperative pulmonary complications. Statistic analysis of the collected data
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Beginning at the end of data collection, possibly August 2027. Ending 3 years after publication of results.
Access criteria: Reviewers. Researchers of relevant subjects. Anesthesiologists with interest in optimum mechanical ventilation. A request via email will be initially needed. A data sharing agreement will be needed to be signed.
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University General Hospital of Patras