AzTrials
AzTrials

General AnesthesiaRAMAGENCT06899295

Prevention of Postoperative Respiratory Complications

An observational study of General Anesthesia and Ventilator-Induced Lung Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Continuous measurement of esophageal pressure Peso (cmH2O), Measurement of impedance variation with each respiratory cycle (EIT), Z in ohm and Measurement of regional respiratory compliance (EIT), Ohm/cmH2O
How many people
34 participants
Where
1 siteFrance
Study dates
May 2026to May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • - 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

France1 site
  • AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care Paris, France, 75010

    Paris, Île-de-France Region, 75010

    Joaquim MATEO, MD, +33 (0)1 49 95 83 74, joaquim.mateo@aphp.fr

    Fabrice VF VALLEE, MD PhD, +33 (0)1 49 95 80 71, fabrice.vallee@gmail.com

Other trials in France

About this study

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

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.

Read more

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.

Read the detailed description

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 a Positive End Expiratory Pressure (PEEP) sufficient to keep the lungs open afterwards. These maneuvers can be performed in a variety of ways but generally involve gradually increasing the level of airway pressure, followed by a stepwise decrease to an end-expiratory pressure (PEEP) level decided by the practitioner based on monitoring data and considering the clinical outcome and hemodynamic tolerance of the maneuver.

Atelectasis essentially occurs when the pressure in the alveolus at the end of expiration is lower than the pressure that allows the alveolus to remain open (critical opening pressure). The principle is to transiently increase transpulmonary pressure (TTP) (the difference between airway pressure (Paw) and pleural pressure) above the critical opening pressure.

Maintaining alveolar end-expiratory pressure (PEEP) after the maneuver is essential to avoid de-recruitment. The concept of the alveolar recruitment maneuver is very popular in our specialty. The benefits and importance of this alveolar recruitment strategy were initially identified in intensive care patients. Particular attention is now being paid to lung-free patients in the operating theatre, especially those with obesity, during long prone surgeries and during laparoscopic abdominal surgery. Currently, the benefits of ARM are also being seen, with a reduced risk of serious pulmonary and extra-pulmonary complications in the first 7 days postoperatively for this type of patient.

Currently, these maneuvers are performed directly on ventilators that incorporate an automated, programmable procedure. The technique consists in gradually increasing inspiratory pressure to 40 cmH2O and PEEP to 20 cmH2O, the incremental phase. As soon as the maximum pressure level is reached, a progressive decrement phase follows. Three parameters need to be set: maximum inspiratory pressure, maximum PEEP and maneuver duration. The level of PEEP at which the alveoli theoretically remain open is determined by monitoring the patient's compliance and tidal volume. This pulmonary hyperinflation not only has a major impact on hemodynamics but also presents a risk of barotrauma. ARM is currently performed without transpulmonary pressure measurement and with this procedure.

For this reason, new-generation ventilators are equipped with an esophageal pressure proxy for pleural pressure, enabling precise calculation of transpulmonary pressure. Only direct measurement of the parameters characterizing the state of the entire respiratory system enables individual, patient-specific adjustment of the critical opening pressure of the alveoli.

Advanced monitoring is now available and integrated into the latest-generation ventilators, and includes the following combination of measurements obtained from the monitors:

  1. Ventilator-integrated
  • Transpulmonary pressure (TPP) is defined as the difference between airway pressure and pleural pressure and provides essential information for individual patient needs on chest wall mechanics, lung mechanics and effects on the respiratory and circulatory systems. Estimation of trans-pulmonary pressure (TPP), pulmonary stress and critical opening pressure is obtained via esophageal manometry (proxy for pleural pressure), the use of which is recommended by several learned societies and is the subject of numerous studies.
  • The study of lung volumes (end-expiratory lung volume, EELV, and a substitute for functional respiratory capacity (FRC) via the study of exhaled CO2 kinetics (volumetric capnography and dynamic capnometry).
  1. Electro-Impedance Tomography (EIT) Electro-Impedance Tomography (EIT) provides a totally non-invasive, cross-sectional visualization of part of the pulmonary aeration, both dynamically and regionally. Current technology also enables us to assess pulmonary perfusion (and thus ventilation/perfusion ratios).

Advantages of this augmented and integrative respiratory monitoring approach during mechanical ventilation under general anesthesia:

  1. Limiting pulmonary stress, excessive and individualizing the setting of tidal volume (TV) and positive end-expiratory pressure (PEEP) to optimize the acceptable recruitment/distension balance.
  2. Obtain information on the gas exchanger and the impact of PEEP-VT optimization on gas exchange.

These maneuvers, with their risk of alveolar overdistension, are potentially dangerous for patients with airway pathologies or difficult ventilator adaptation conditions.

Consequently, the practice of applying a fixed standardized maneuver to a particular patient is risky, and more rigorous control of the optimal end-expiratory pressure level PEEP (critical opening pressure) from advanced monitoring data would be desirable. Customization of this alveolar recruitment maneuver is particularly suited to the population we will be studying (obese, prone, laparoscopic surgery).

The application of MRA during anesthesia normalizes pulmonary function intraoperatively. There is physiological evidence that patients of all ages, whatever the type of surgery, benefit from such active intervention. The risks must be minimized.

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). To combine data on ventilation/perfusion ratios measured by EIT with optimization of the aeric ventilatory side. Describe and analyze the recorded data a posteriori and establish a relationship between the PEEP values set by conventional ARM and those determined from advanced monitoring combining EIT and TPP. These analyses will enable us to assess the complementarity and added value of these values in practice, and the respective usefulness of the different indices.

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

Being 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).
Keywords
Ventilator optimization, Ventilator induced lung injury
Medical subject headings
Ventilator-Induced Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 ohmDiagnostic test

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

  • Measurement of regional respiratory compliance (EIT), Ohm/cmH2ODiagnostic 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 paralyticsDiagnostic test

    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, duratioDiagnostic test

    These parameters will be recorded during the perioperative hospitalization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (2)
  1. To establish the relationship between the characteristics and combination of monitoring data and the occurrence of postoperative respiratory complications during the 5 postoperative days.

    Arozullah score (Risk of postoperative pulmonary complications Arozullah)

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

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

    Weight and height will be combined to report BMI in kg/m^2.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2025
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06899295
Sponsor's protocol ID
APHP241304
Other IDs
2024-A01853-44
Acronym
RAMAGE
Status last verified
Feb 2026
First submitted
24 Feb 2025
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of General Anesthesia and Ventilator-Induced Lung Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joaquim MATEO, MD (+33 (0)149958374, joaquim.mateo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in