Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.
NCT ID: NCT04036175
Last Updated: 2019-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2018-03-06
2020-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1
Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition)
High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen
Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2\>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2\>= 92%
Group 2
Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition)
High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen
Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2\>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2\>= 92%
Interventions
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High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen
Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2\>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2\>= 92%
Eligibility Criteria
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Inclusion Criteria
* planned extubation decided by the physician in charge of the patient after success of weaning trial
* patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease
* Hypoxemia defined by PaO2/FiO2 \< 300 mmHg under mechanical ventilation before extubation
Exclusion Criteria
* Contraindication to NIV
* Contraindication to nasogastric tube
* Do-not-reintubated order at time of extubation
* People under legal protection
* Opposition to participate
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Principal Investigators
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Arnaud W. THILLE, PUPH
Role: PRINCIPAL_INVESTIGATOR
Medecine intensive reanimation CHU Poitiers
Locations
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CHU Poitiers
Poitiers, , France
Intensive reanimation
Poitiers, , France
Countries
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Central Contacts
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Facility Contacts
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Arnaud W THILLE, Pr
Role: primary
Arnaud THILLE
Role: primary
Jean-Pierre FRAT
Role: backup
References
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Arrive F, Le Pape S, Bruhn A, Pepin Lehalleur A, Beuvon C, Tuffet S, Etien E, Rambault L, Frat JP, Coudroy R, Thille AW. Physiological comparison of noninvasive ventilation and high-flow nasal oxygen on inspiratory efforts and tidal volumes after extubation: a randomized crossover trial. Crit Care. 2025 May 8;29(1):185. doi: 10.1186/s13054-025-05366-y.
Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.
Other Identifiers
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2017-A02838-45
Identifier Type: -
Identifier Source: org_study_id