Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

NCT07186933 | Recruiting

• 1 other identifier: 22624 / 4.8.2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Is MV with lower ΔP better than conventional PMV in preventing PPCs in patients with higher risk for PPCs?
• Does MV with lower ΔP decrease hospital stay, Intensive Care Unit (ICU) need and mortality?
• Does MV with lower ΔP suit better than PMV to lung characteristics and needs intraoperatively? 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.

Conditions

Postoperative Pulmonary Atelectasis; Postoperative Pulmonary Complications; Postoperative Respiratory Failure; Postoperative Bronchospasm; Postoperative Pleural Effusion; Postoperative Pneumothorax; Postoperative Pneumonia; Postoperative Aspiration Pneumonitis; Mechanical Power; Driving Pressure

Keywords

Driving Pressure; Mechanical Power; Atelectasis; Pulmonary Complications; Postoperative Pulmonary Complications; Postoperative Respiratory Failure; Elastic Power

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (8)

• Hospital Stay

  From day of operation until the end of patient stay inside hospital, because of return to home or due to death.

• ICU need.

  From day of operation until the end of patient stay inside hospital, because of return to home or due to death.

• ICU stay

  From day of operation until the end of patient stay inside hospital, because of return to home or due to death.

• 28 Day mortality

  From day of operation until up to 28 days.

• Mechanical Power (MP)

  From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation

Study Arms (2)

Lung Protective Ventilation

OTHER

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

Minimum Driving Pressure

ACTIVE COMPARATOR

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

Interventions

PEEP titration for Minimum Driving Pressure PROCEDURE

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

Minimum Driving Pressure

Lung Protective Ventilation PROCEDURE

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

Lung Protective Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>17 years old
• Surgery with general anesthesia \& invasive mechanical ventilation
• Preoperative ARISCAT score estimation \>25

You may not qualify if:

• \<18 years old
• Preoperative ARISCAT score estimation \<26
• Women during pregnancy or just given birth
• Other type of anesthesia (Not general)
• Contraindication of administration of neuromuscular blockade agents.
• Contraindication of cease of spontaneous ventilation.
• Mechanical ventilation without endotracheal intubation.
• Severe heart failure / Severe cardiac arrhythmia.
• Severe emphysematous lung disease.
• Patient denial of participation in the trial.

Sponsors & Collaborators

• University General Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, 26504, Greece

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Diamanto Aretha, A. Professor

  University of Patras

  STUDY DIRECTOR

• Antonios Kostouros, Resident

  University of Patras

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonios D Kostouros, Resident

CONTACT

+306975920528; kostouros.a@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinsipal Investigator, Antonios Kostouros

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 22, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.

Locations

GR (1)