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Ventilation Strategies During Spontaneous Breathing Trial (WEANING)

Primary Purpose

Acute Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ATC then pressure support 7 cm H2O PEP 4 cm H2O
Pressure support 7 cm H2O PEP 4 cm H2O then ATC
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Insufficiency focused on measuring weaning, mechanical ventilation, work of breathing, automatic tube compensation, pressure support ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital de la Croix Rousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ATC then pressure support 7 cm H2O PEP 4 cm H2O

pressure support 7 cm H2O PEP 4 cm H2O then ATC

Arm Description

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

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

Outcomes

Primary Outcome Measures

the power of work of breathing
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

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

Full Information

First Posted
October 19, 2016
Last Updated
November 26, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02939963
Brief Title
Ventilation Strategies During Spontaneous Breathing Trial
Acronym
WEANING
Official Title
Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Insufficiency
Keywords
weaning, mechanical ventilation, work of breathing, automatic tube compensation, pressure support ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATC then pressure support 7 cm H2O PEP 4 cm H2O
Arm Type
Experimental
Arm Description
spontaneous breathing through endotracheal tube with no ventilator support except for ATC
Arm Title
pressure support 7 cm H2O PEP 4 cm H2O then ATC
Arm Type
Experimental
Arm Description
ventilator is set to pressure support ventilation mode at set pressure 7 cm H2O above PEEP level of 4 cm H2O
Intervention Type
Procedure
Intervention Name(s)
ATC then pressure support 7 cm H2O PEP 4 cm H2O
Intervention Description
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
Intervention Name(s)
Pressure support 7 cm H2O PEP 4 cm H2O then ATC
Intervention Description
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 Outcome Measure Information:
Title
the power of work of breathing
Description
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
Time Frame
30 minutes after onset the ventilator strategy
Secondary Outcome Measure Information:
Title
Respiratory rate
Description
the respiratory rate is measured from the airflow tracing
Time Frame
30 minutes
Title
tidal volume
Description
integration of airflow over time during expiration
Time Frame
30 minutes
Title
intrinsic PEP
Description
deflection in esophageal pressure up to the first zero flow
Time Frame
30 minutes
Title
occlusion pressure at 100 ms
Description
measured from the airway pressure at the first 100 ms after airway occlusion
Time Frame
30 minutes
Title
work of breathing per liter
Description
work of breathing normalized for 1 liter tidal volume
Time Frame
30 minutes
Title
Distribution of pulmonary ventilation
Description
distribution of pulmonary ventilation will be measured by the Pulmovista system
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Guerin, Pr
Organizational Affiliation
Hôpital de la Croix-Rousse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

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Ventilation Strategies During Spontaneous Breathing Trial

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