Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02939963 |
Date of registration:
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19/10/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Ventilation Strategies During Spontaneous Breathing Trial
WEANING |
Scientific title:
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Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients |
Date of first enrolment:
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August 23, 2017 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02939963 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Claude Guerin, Pr |
Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital de la Croix-Rousse |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Respiratory Insufficiency
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Intervention(s)
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Procedure: Pressure support 7 cm H2O PEP 4 cm H2O then ATC
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Procedure: ATC then pressure support 7 cm H2O PEP 4 cm H2O
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Primary Outcome(s)
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the power of work of breathing
[Time Frame: 30 minutes after onset the ventilator strategy]
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Secondary Outcome(s)
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occlusion pressure at 100 ms
[Time Frame: 30 minutes]
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work of breathing per liter
[Time Frame: 30 minutes]
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Distribution of pulmonary ventilation
[Time Frame: 30 minutes]
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intrinsic PEP
[Time Frame: 30 minutes]
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Respiratory rate
[Time Frame: 30 minutes]
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tidal volume
[Time Frame: 30 minutes]
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Secondary ID(s)
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69HCL16_0411
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2016-A01172-49
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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