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NOT YET RECRUITING
NCT06899295

Prevention of Postoperative Respiratory Complications

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Data From Advanced Respiratory Monitoring During Alveolar Recruitment Maneuvers (ARM). A Prospective Observational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

34

Start Date

2026-05

Completion Date

2028-05

Last Updated

2026-02-18

Healthy Volunteers

No

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

Locations (1)

AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care Paris, France, 75010

Paris, Île-de-France Region, France