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Ventilation Strategies During Spontaneous Breathing Trial (WEANING)

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ClinicalTrials.gov Identifier: NCT02939963
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Insufficiency Procedure: ATC then pressure support 7 cm H2O PEP 4 cm H2O Procedure: Pressure support 7 cm H2O PEP 4 cm H2O then ATC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients
Actual Study Start Date : August 23, 2017
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ATC then pressure support 7 cm H2O PEP 4 cm H2O
spontaneous breathing through endotracheal tube with no ventilator support except for ATC
Procedure: 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

Experimental: 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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939963


Locations
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France
Hôpital de la Croix Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Claude Guerin, Pr Hôpital de la Croix-Rousse

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02939963     History of Changes
Other Study ID Numbers: 69HCL16_0411
2016-A01172-49 ( Other Identifier: ANSM Number )
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
weaning
mechanical ventilation
work of breathing
automatic tube compensation
pressure support ventilation

Additional relevant MeSH terms:
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Respiratory Aspiration
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases