NCT06899295: RAMAGE

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

Not yet recruiting Last updated 17 February 2026

What this trial tests

trial testing Continuous measurement of esophageal pressure Peso (cmH2O) in General Anesthesia in 34 participants. Not yet recruiting.

Timeline

1 May 2026

Primary endpoint
1 May 2028

1 May 2028

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	34
Start date	1 May 2026
Primary completion	1 May 2028
Estimated completion	1 May 2028
Sites	1 location across France

Drugs / interventions tested

• Continuous measurement of esophageal pressure Peso (cmH2O)
• Measurement of impedance variation with each respiratory cycle (EIT), Z in ohm
• Measurement of regional respiratory compliance (EIT), Ohm/cmH2O
• Measurement 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 paralytics
• Demographic criteria: age, sex, height, weight, BMI, theoretical ideal weight, ASA. - Procedure-related criteria: type of surgery, technique (laparoscopic, endoscopic, laparoscopic), position, duratio

Conditions studied

• General Anesthesia — all drugs for General Anesthesia →
• Ventilator-Induced Lung Injuries — all drugs for Ventilator-Induced Lung Injuries →
• Postoperative Respiratory Complications — all drugs for Postoperative Respiratory Complications →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with General Anesthesia or Ventilator-Induced Lung Injuries. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.