Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

NCT ID: NCT07186933

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Lung Protective Ventilation

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

Group Type: OTHER

Lung Protective Ventilation

Intervention Type: 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

Minimum Driving Pressure

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

Group Type: ACTIVE_COMPARATOR

PEEP titration for Minimum Driving Pressure

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Lung Protective 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

Intervention Type: PROCEDURE

Other Intervention Names

Maximum compliance mechanical ventilation; Cmax Mechanical Ventilation

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• <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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University General Hospital of Patras

OTHER

Sponsor Role: lead

Responsible Party

Antonios Kostouros

Prinsipal Investigator, Antonios Kostouros

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diamanto Aretha, A. Professor

Role: STUDY_DIRECTOR

University of Patras

Antonios Kostouros, Resident

Role: PRINCIPAL_INVESTIGATOR

University of Patras

Central Contacts

Antonios D Kostouros, Resident

Role: CONTACT

kostouros.a@yahoo.com

+306975920528

Other Identifiers

22624 / 4.8.2025

Identifier Type: -

Identifier Source: org_study_id