Prevention of Postoperative Respiratory Complications

NCT06899295 | Not Yet Recruiting

• 2 other identifiers: APHP2413042024-A01853-44
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ventilator optimization; Ventilator induced lung injury

Outcome Measures

Primary Outcomes (1)

• Compare the PEEP setting values obtained from a standardized ARM with the theoretical values obtained from advanced monitoring for the same patient.

  PEEP levels (cmH2O)

  These parameters will be recorded during the alveolar recruitment maneuvers routinely performed during general anesthesia (one day)

Secondary Outcomes (2)

• To establish the relationship between the characteristics and combination of monitoring data and the occurrence of postoperative respiratory complications during the 5 postoperative days.

  Acquisition and recording of monitoring data and postoperative respiratory complications during the 5 postoperative days (5 days).

• Stratify physiological data according to the main phenotypes which determine respiratory mechanics (obesity, prone position, laparoscopic surgery).

  Acquisition and recording of monitoring data and postoperative respiratory complications during the 5 postoperative days.

Interventions

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

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) DIAGNOSTIC_TEST

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). DIAGNOSTIC_TEST

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

Quantification of delivered doses of hypnotics, morphine and paralytics DIAGNOSTIC_TEST

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

Continuous measurement of esophageal pressure Peso (cmH2O) DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

This parameter 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 DIAGNOSTIC_TEST

These parameters will be recorded during the perioperative hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing planned surgery under prolonged general anesthesia (\> 2 hour forecast) * in prone position Or * laparoscopic abdominal surgery Or * Obese patients BMI \> 35

You may qualify if:

• Patients ≥ 18 years of age
• 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.
• Patient informed and expressing non-opposition to participation in this study

You may not qualify if:

• \- 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

Sponsors & Collaborators

• M3DISIM: collaborator
• INSERM UMR-942, Paris, France: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Interventions

Hemodynamics; Temperature; Sex; Body Height; Body Mass Index; Laparoscopy; Endoscopy

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment, Controlled; Environment and Public Health; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development; Biometry; Epidemiologic Measurements; Public Health; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Joaquim MATEO, MD

CONTACT

+33 (0)149958374; joaquim.mateo@aphp.fr

Fabrice VALLEE, MD PhD

CONTACT

+33 (0)1 49 95 80 71; fabrice.vallee@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 27, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

FR (1)