NCT02939963: WEANING

Ventilation Strategies During Spontaneous Breathing Trial

Completed NA Last updated 18 September 2025

What this trial tests

NA trial testing ATC then pressure support 7 cm H2O PEP 4 cm H2O in Acute Respiratory Insufficiency in 20 participants. Completed in 5 October 2018.

Timeline

23 August 2017

Primary endpoint
5 October 2018

5 October 2018

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	23 August 2017
Primary completion	5 October 2018
Estimated completion	5 October 2018
Sites	1 location across France

Drugs / interventions tested

• ATC then pressure support 7 cm H2O PEP 4 cm H2O
• Pressure support 7 cm H2O PEP 4 cm H2O then ATC

Conditions studied

• Acute Respiratory Insufficiency — all drugs for Acute Respiratory Insufficiency →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Acute Respiratory Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Low-pressure support vs automatic tube compensation during spontaneous breathing trial for weaning.
   Guérin C, Terzi N, Mezidi M, Baboi L, et al · · 2019 · cited 13× · PMID 31836913 · DOI 10.1186/s13613-019-0611-y
2. ESICM LIVES 2019 : Berlin, Germany. 28 September - 2 October 2019.
   · 2019 · cited 8× · PMID 31559498 · DOI 10.1186/s40635-019-0265-y