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Prevention of Postoperative Respiratory Complications

ConditionsGeneral AnesthesiaVentilator-Induced Lung InjuriesPostoperative Respiratory Complications
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 years of age

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

Disqualifiers

- Patients under 18 years of age.

Contraindications to esophageal tube placement

Contraindications to ARMs

Patient opposed to protocol participation

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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

  • 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

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

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)

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

Secondary outcomes

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)

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

M3DISIM

Collaborator

INSERM UMR-942, Paris, France

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: