Prevention of Postoperative Respiratory Complications

NCT06899295 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2026-02-18

No results posted yet for this study

Summary

Given the huge number of patients mechanically ventilated during general anaesthesia, optimizing alveolar recruitment by limiting pulmonary and systemic aggression is a key objective for further progress in perioperative patient management.

During general anaesthesia, ventilation disorders with atelectasis, derecruitment of posteroinferior zones and reduced functional residual capacity (FRC) occur in relation to the operative position, the effect of neuromuscular block and general anaesthesia. These conditions of poor pulmonary aeration favor postoperative respiratory complications and are responsible for excess mortality in the perioperative period.

Alveolar recruitment maneuvers (ARMs) are ventilatory strategies used during general anesthesia that aim to restore lung aeration with Positive End Expiratory Pressure (PEEP) sufficient to keep the lungs open afterwards. This pulmonary hyperinflation not only has a major impact on hemodynamics but also presents a risk of barotrauma. ARM is currently performed without precise measurement of the pressures prevailing in the lung.

Advanced monitoring is now available and integrated into the latest-generation ventilators and includes the combination of Transpulmonary pressure (TPP) and Electro-Impedance Tomography " (EIT) measurements.

The aim of this observational study is to measure and record advanced respiratory monitoring data in a minimally invasive way, during alveolar recruitment tests routinely performed for the target population (obese, prone, laparoscopic surgery). Describe and a posteriori analyze the recorded data and establish a relationship between the PEEP values set by conventional ARM and those determined by advanced monitoring combining EIT and PTP for the same patient.

Conditions

  • General Anesthesia
  • Ventilator-Induced Lung Injuries
  • Postoperative Respiratory Complications

Interventions

DIAGNOSTIC_TEST

Continuous measurement of esophageal pressure Peso (cmH2O)

This parameter will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia.

DIAGNOSTIC_TEST

Measurement of impedance variation with each respiratory cycle (EIT), Z in ohm

This parameter will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia

DIAGNOSTIC_TEST

Measurement of regional respiratory compliance (EIT), Ohm/cmH2O

This parameter will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia

DIAGNOSTIC_TEST

Measurement of lung volumes (EELV or CRF) mL, (ml/kg)

These parameters will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia

DIAGNOSTIC_TEST

Continuous measurement of multiparametric monitoring data in place (hemodynamics, depth of sedation, respiratory data, temperature).

These parameters will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia

DIAGNOSTIC_TEST

Quantification of delivered doses of hypnotics, morphine and paralytics

These parameters will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia

DIAGNOSTIC_TEST

Demographic criteria: age, sex, height, weight, BMI, theoretical ideal weight, ASA. - Procedure-related criteria: type of surgery, technique (laparoscopic, endoscopic, laparoscopic), position, duratio

These parameters will be recorded during the perioperative hospitalization

Sponsors & Collaborators

  • M3DISIM

    collaborator OTHER
  • INSERM UMR-942, Paris, France

    collaborator OTHER
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06899295 on ClinicalTrials.gov