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Clinical Trials/NCT02939963
NCT02939963
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country20 target enrollmentAugust 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Insufficiency
Sponsor
Hospices Civils de Lyon
Enrollment
20
Locations
1
Primary Endpoint
the power of work of breathing
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2017
End Date
October 5, 2018
Last Updated
7 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • occlusion pressure at 100 ms(30 minutes)
  • tidal volume(30 minutes)
  • Respiratory rate(30 minutes)
  • intrinsic PEP(30 minutes)
  • work of breathing per liter(30 minutes)
  • Distribution of pulmonary ventilation(30 minutes)

Study Sites (1)

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