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NCT Number: NCT02939963

Ventilation Strategies During Spontaneous Breathing Trial

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.

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Key information

Conditions

Acute Respiratory Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATC then pressure support 7 cm H2O PEP 4 cm H2O

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

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

Primary outcomes

  1. the power of work of breathing

    Time frame: 30 minutes after onset the ventilator strategy

    the work of breathing is measured from the area subtended by the esophageal pressure - lung volume relationship. The power of work of breathing is obtained by multiplying work of breathing by the respiratory frequency and expressed in Joules/min

Secondary outcomes

  1. Respiratory rate

    Time frame: 30 minutes

    the respiratory rate is measured from the airflow tracing

  2. tidal volume

    Time frame: 30 minutes

    integration of airflow over time during expiration

  3. intrinsic PEP

    Time frame: 30 minutes

    deflection in esophageal pressure up to the first zero flow

  4. occlusion pressure at 100 ms

    Time frame: 30 minutes

    measured from the airway pressure at the first 100 ms after airway occlusion

  5. work of breathing per liter

    Time frame: 30 minutes

    work of breathing normalized for 1 liter tidal volume

  6. Distribution of pulmonary ventilation

    Time frame: 30 minutes

    distribution of pulmonary ventilation will be measured by the Pulmovista system

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients

Acronym: WEANING

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2016
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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