Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity General Hospital of Patras

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

>17 years old

Surgery with general anesthesia & invasive mechanical ventilation

Preoperative ARISCAT score estimation >25

Disqualifiers

<18 years old

Preoperative ARISCAT score estimation <26

Women during pregnancy or just given birth

Other type of anesthesia (Not general)

Trial design

Design model

Parallel

Treatments tested in this trial

  • PEEP titration for Minimum Driving Pressure

    Procedure/Surgery

    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

  • Lung Protective Ventilation

    Procedure/Surgery

    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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Lung Protective VentilationOther 1 intervention
Group B: Minimum Driving PressureActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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.
2

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.
3

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.
4

28 Day mortality

Incidence of death in 28 days in each group.

Time frame
From day of operation until up to 28 days.

Other outcomes

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