Ventilation Strategies During Spontaneous Breathing Trial

NCT ID: NCT02939963

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2018-10-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATC then pressure support 7 cm H2O PEP 4 cm H2O

spontaneous breathing through endotracheal tube with no ventilator support except for ATC

Group Type: EXPERIMENTAL

ATC then pressure support 7 cm H2O PEP 4 cm H2O

Intervention Type: PROCEDURE

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

pressure support 7 cm H2O PEP 4 cm H2O then ATC

ventilator is set to pressure support ventilation mode at set pressure 7 cm H2O above PEEP level of 4 cm H2O

Group Type: EXPERIMENTAL

Pressure support 7 cm H2O PEP 4 cm H2O then ATC

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age 18 years or more
• intubated and mechanically ventilated for at least 24 consecutive hours
• staying in the medical ICU at the Croix Rousse Hospital, Lyon, France
• pressure support ventilation 10-15 cm H2O, total respiratory rate 25-35 breaths/min, expired tidal volume 6-8 ml/kg predicted body weight
• meeting criteria for spontaneous breathing trial (able to answer simple questions, no ongoing intravenous sedation, norepinephrine ≤ 1 mg/H, dobutamine ≤ 20 mg/h, fraction of inspired oxygen (FIO2 ≤ 50%), PEP ≤ 5 cm H2O, respiratory rate ≤ 35 breaths/min, saturation in oxygen (SpO2) ≥88%)
• under Dräger Evita XL ou V500 ICU ventilator
• agreement to participate from the patient or next of kin

Exclusion Criteria

• Chronic respiratory failure under long term home oxygen therapy and/or non invasive ventilation before ICU admission
• Tracheotomy
• nasogastric tube contra-indicated
• thoracic tube in place
• no agreement to participate
• under justice protection
• deprived of freedom
• pregnant or breastfeeding
• not affiliated to social insurance
• involved into another study that may interfere with present study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claude Guerin, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital de la Croix-Rousse

Locations

Hôpital de la Croix Rousse

Lyon, , France

Countries

France

References

Guerin C, Terzi N, Mezidi M, Baboi L, Chebib N, Yonis H, Argaud L, Heunks L, Louis B. Low-pressure support vs automatic tube compensation during spontaneous breathing trial for weaning. Ann Intensive Care. 2019 Dec 13;9(1):137. doi: 10.1186/s13613-019-0611-y.

Reference Type: RESULT

PMID: 31836913 (View on PubMed)

Other Identifiers

2016-A01172-49

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL16_0411

Identifier Type: -

Identifier Source: org_study_id