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Starting soon Observational

Prevention of Postoperative Respiratory Complications

NCT06899295 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-05
Last updated
2026-02-18

Condition(s) studied

General AnesthesiaVentilator-Induced Lung InjuriesPostoperative Respiratory Complications

Investigational drug(s) / intervention(s)

Continuous measurement of esophageal pressure Peso (cmH2O)Measurement of impedance variation with each respiratory cycle (EIT), Z in ohmMeasurement of regional respiratory compliance (EIT), Ohm/cmH2OMeasurement of lung volumes (EELV or CRF) mL, (ml/kg)Continuous measurement of multiparametric monitoring data in place (hemodynamics, depth of sedation, respiratory data, temperature).Quantification of delivered doses of hypnotics, morphine and paralyticsDemographic criteria: age, sex, height, weight, BMI, theoretical ideal weight, ASA. - Procedure-related criteria: type of surgery, technique (laparoscopic, endoscopic, laparoscopic), position, duratio

Continuous measurement of esophageal pressure Peso (cmH2O): This parameter will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia.

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

Measurement of regional respiratory compliance (EIT), Ohm/cmH2O: This parameter will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia

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

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

Quantification of delivered doses of hypnotics, morphine and paralytics: These parameters will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients ≥ 18 years of age 2. undergoing : * scheduled surgery at Hospital Lariboisière. * scheduled to last more than 2 hours under general anesthesia for abdominal surgery under laparoscopy or surgery in the prone position, or for obese patients with a BMI \>35. * And for whom the ventilator used includes advanced monitoring * for whom placement of a gastric tube is indicated either because of the duration of the procedure or because it is necessary for the surgery. 3. Patient informed and expressing non-opposition to participation in this study Exclusion Criteria: * \- Patients under 18 years of age. * Contraindications to esophageal tube placement * Contraindications to ARMs * Patient opposed to protocol participation * Pregnant, parturient or breast-feeding women * Patient under legal protection

Primary outcome measure(s)

  • Compare the PEEP setting values obtained from a standardized ARM with the theoretical values obtained from advanced monitoring for the same patient. — These parameters will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia (one day)
    PEEP levels (cmH2O)

Trial sites (1)

FacilityCityRegionStatus
AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care Paris, France, 75010 Paris Île-de-France Region
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06899295 on ClinicalTrials.gov ↗ ← All trials in France