Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications
- Conditions
- Postoperative Pulmonary AtelectasisPostoperative Pulmonary ComplicationsPostoperative Respiratory FailurePostoperative BronchospasmPostoperative Pleural EffusionPostoperative PneumothoraxPostoperative PneumoniaPostoperative Aspiration PneumonitisMechanical PowerDriving Pressure
- Registration Number
- NCT07186933
- Lead Sponsor
- University General Hospital of Patras
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
- <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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative Pulmonary Complications 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 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
- Secondary Outcome Measures
Name Time Method Hospital Stay From day of operation until the end of patient stay inside hospital, because of return to home or due to death. Total hospital stay days from day of operation until hospital discharge.
ICU need. From day of operation until the end of patient stay inside hospital, because of return to home or due to death. Potential Need for ICU admission.
ICU stay From day of operation until the end of patient stay inside hospital, because of return to home or due to death. In case of ICU need, total days of ICU stay.
28 Day mortality From day of operation until up to 28 days. Incidence of death in 28 days in each group.
Mechanical Power (MP) From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation 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 × \[Ppeak - (Plat-PEEP)/2\]
Volume-normalized Mechanical Power (MPcrs) From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation MPcrs = MP/Respiratory System Compliance (Crs)
Elastic Power (EP) From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation To calculate EP, the following must be recorded: RR, VT, Pplat, and PEEP. The following equation will be used: EP = 0.098 × RR × VT × \[(Plat+PEEP)/2\]
Volume-normalized Elastic Power (EPcrs) From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation EPcrs = EP/Crs