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Ventilation Strategies During Spontaneous Breathing Trial

NCT02939963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-18

No results posted yet for this study

Summary

Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.

Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.

Conditions

  • Acute Respiratory Insufficiency

Interventions

PROCEDURE

ATC then pressure support 7 cm H2O PEP 4 cm H2O

spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O during 30 minutes then 30 minutes of basal pressure support then 30 minutes with pressure support 7 cm H2O PEP 4 cm H2O

PROCEDURE

Pressure support 7 cm H2O PEP 4 cm H2O then ATC

30 minutes with pressure support 7 cm H2O PEP 4 cm H2O then 30 minutes of basal pressure support then 30 minutes with spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Claude Guerin, Pr · Hôpital de la Croix-Rousse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2018-10-05
Completion
2018-10-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02939963 on ClinicalTrials.gov