Ventilation Strategies During Spontaneous Breathing Trial

Not Applicable

Completed

• Conditions: Acute Respiratory Insufficiency
• Interventions: Procedure: ATC then pressure support 7 cm H2O PEP 4 cm H2O; Procedure: Pressure support 7 cm H2O PEP 4 cm H2O then ATC

• Registration Number: NCT02939963
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Study Start: 2017-08-23
• Primary Completion: 2018-10-05
• Study Completion: 2018-10-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ATC then pressure support 7 cm H2O PEP 4 cm H2O	ATC then pressure support 7 cm H2O PEP 4 cm H2O	spontaneous breathing through endotracheal tube with no ventilator support except for ATC
pressure support 7 cm H2O PEP 4 cm H2O then ATC	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

Primary Outcome Measures

Name	Time	Method
the power of work of breathing	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 Outcome Measures

Name	Time	Method
occlusion pressure at 100 ms	30 minutes	measured from the airway pressure at the first 100 ms after airway occlusion
tidal volume	30 minutes	integration of airflow over time during expiration
Respiratory rate	30 minutes	the respiratory rate is measured from the airflow tracing
intrinsic PEP	30 minutes	deflection in esophageal pressure up to the first zero flow
work of breathing per liter	30 minutes	work of breathing normalized for 1 liter tidal volume
Distribution of pulmonary ventilation	30 minutes	distribution of pulmonary ventilation will be measured by the Pulmovista system

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France