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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02939963
Date of registration: 19/10/2016
Prospective Registration: Yes
Primary sponsor: Hospices Civils de Lyon
Public title: Ventilation Strategies During Spontaneous Breathing Trial WEANING
Scientific title: Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients
Date of first enrolment: August 23, 2017
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02939963
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Claude Guerin, Pr
Address: 
Telephone:
Email:
Affiliation:  Hôpital de la Croix-Rousse
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Acute Respiratory Insufficiency
Intervention(s)
Procedure: Pressure support 7 cm H2O PEP 4 cm H2O then ATC
Procedure: ATC then pressure support 7 cm H2O PEP 4 cm H2O
Primary Outcome(s)
the power of work of breathing [Time Frame: 30 minutes after onset the ventilator strategy]
Secondary Outcome(s)
occlusion pressure at 100 ms [Time Frame: 30 minutes]
work of breathing per liter [Time Frame: 30 minutes]
Distribution of pulmonary ventilation [Time Frame: 30 minutes]
intrinsic PEP [Time Frame: 30 minutes]
Respiratory rate [Time Frame: 30 minutes]
tidal volume [Time Frame: 30 minutes]
Secondary ID(s)
69HCL16_0411
2016-A01172-49
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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