EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery

ConditionsMechanical Power Postoperative Pulmonary Complications (PPCs)Oxygenation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorPest County Flór Ferenc Hospital

About this trial

The goal of this randomized controlled clinical trial is to compare the pulmonary protective effects of two different positive end-expiratory pressure (PEEP) titrating methods in patients with non-injured lungs undergoing laparoscopic gynecological surgery.

Despite dynamic pulmonary compliance (Cdyn) guided lung protective ventilation has several proven advantages, the investigators hypothesize that optimizing intraoperative mechanical ventilation using electrical impedance tomography (EIT) may further improve patient outcomes, enhance postoperative recovery, shorten in-hospital stay and reduce healthcare related costs.

The main questions aim to answer are:

* May EIT-guided PEEP titration reduce the mechanical power of ventilation and improve oxygenation more significantly than the Cdyn-guided method? * What effect might a decrease in mechanical power of ventilation have on postoperative pulmonary complications?

Participants will:

* Receive an EIT-guided or a Cdyn-guided PEEP titration procedure during laparoscopic gynecological surgery. * Be assessed for mechanical power of ventilation, oxygenation, atelectasis and postoperative pulmonary complications during and 2 days after surgery. * Be followed-up for mortality until the 28th postoperative day.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient scheduled for elective laparoscopic gynaecological surgery

Age > 18 years

Signed consent to participate in the trial

Disqualifiers

Age < 18 years

American Society of Anesthesiologists (ASA) physical status IV

History of severe restrictive or chronic obstructive pulmonary disease (COPD, Global Initiative for Chronic Obstructive Lung Disease grades III or IV)

Uncontrolled bronchial asthma

Trial design

Design model

Parallel

Treatments tested in this trial

EIT-guided PEEP titration
Procedure/Surgery
During the PEEP titration procedure, PEEP will be decreased from 18 cmH2O by 2 cmH2O every 20 ventilatory cycles, until a final PEEP of 6 cmH2O. On each level of PEEP EIT parameters and Cdyn values will be recorded in both groups. In the EIT-GROUP optimal PEEP is considered as the intersect between the lower percentage of overdistension and collapse, based on the diagnostic tool of the EIT device.
Cdyn-guided PEEP titration
Procedure/Surgery
During the PEEP titration procedure, PEEP will be decreased from 18 cmH2O by 2 cmH2O every 20 ventilatory cycles, until a final PEEP of 6 cmH2O. On each level of PEEP EIT parameters and Cdyn values will be recorded in both groups. In the Cdyn-GROUP optimal PEEP is considered as the PEEP value resulting the highest possible Cdyn measured by the ventilator.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: EIT-GROUPExperimental treatment 1 intervention

Group B: Cdyn-GROUPActive comparator 1 intervention

Trial outcomes

Primary outcomes

Mechanical Power (MP)

MP is calculated using a comprehensive formula for volume-controlled ventilator mode: MP = 0.098 x RR x TV (L) x \[ Ppeak - ½ x (Pplat - PEEP)\] (RR: respiratory rate TV: tidal volume Ppeak: airway peak pressure Pplat: plateau pressure PEEP: positive end-expiratory pressure)

Time frame

During surgery

Secondary outcomes

Oxygenation

Oxygenation indicated by the PaO2/FiO2 ratio

Time frame

From the beginning of surgery to 48 hours after surgery

Positive end-expiratory pressure (PEEP)

The level of individually optimal PEEP determined during a PEEP titration procedure

Time frame

During surgery

Dynamic pulmonary compliance (Cdyn)

Dynamic pulmonary compliance measured by the ventilator during mechanical ventilation

Time frame

During surgery

Driving pressure (dP)

Driving pressure - as an important safety limit of mechanical ventilation - is calculated using a formula: dP = Pplat - PEEP (Pplat: plateau pressure, PEEP: positive end-expiratory pressure)

Time frame

During surgery

Other outcomes

Length of hospital stay

Length of hospital stay in days after surgery

Time frame

From the date of surgery until discharge, up to 28 days

In-hospital mortality

Death occured during hospital stay after surgery

Time frame

From date of surgery until the date of death, up to 28 days

28-days mortality

Death occured during 28 days after surgery

Time frame

28 days after surgery

Adverse events related to the PEEP titrating procedure

Adverse Events (AEs) related to the PEEP titrating procedure are defined as: severe or prolonged hypotension (systolic blood pressure \< 90 mmHg); significant cardiac arrhythmias Serious adverse events (SAEs) related to the PEEP titrating procedure are defined as: severe barotrauma leading to pneumothorax; significant prolongation of hospitalization; persistent or significant disability or incapacity; severe deterioration (life-threatening state or even death)

Time frame

During surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pest County Flór Ferenc Hospital

Lead sponsor

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

Collaborator

Semmelweis University

Collaborator

Source ClinicalTrials.gov

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