Back to resultsComparison 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. (OVNI)
Primary Purpose
ICU, Extubation, Non-invasive Ventilation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen
Sponsored by
About this trial
This is an interventional treatment trial for ICU
Eligibility Criteria
Inclusion Criteria:
- Minimum age: 18 years
- 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:
- Duration of mechanical ventilation prior to extubation < 24h
- Contraindication to NIV
- Contraindication to nasogastric tube
- Do-not-reintubated order at time of extubation
- People under legal protection
- Opposition to participate
Sites / Locations
- CHU PoitiersRecruiting
- Intensive reanimationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1
Group 2
Arm Description
Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition)
Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition)
Outcomes
Primary Outcome Measures
Patient respiratory effort and tidal volume (Vt)
Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography
Secondary Outcome Measures
Respiratory parameters
respiratory rate (FR bt/min)
Respiratory parameters
saturation (SpO2 in %)
Respiratory parameters
transcutaneous CO2 pressure (PCO2 in mm Hg)
Respiratory parameters
transpulmonary pressure (cm H2O)
Hemodynamic parameters
Systolic arterial pressure (PAS in mmHg), Diastolic arterial pressure (PAD in mmHg)
Comfort evaluation
comfort evaluation with an visual evaluation scale graduate 0 cm (No discomfort) to 10 cm (maximal discomfort)
Full Information
NCT ID
NCT04036175
First Posted
June 17, 2019
Last Updated
July 29, 2019
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04036175
Brief Title
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.
Acronym
OVNI
Official Title
Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
March 6, 2020 (Anticipated)
Study Completion Date
March 6, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU, Extubation, Non-invasive Ventilation, High-Flow Nasal Oxygen Therapy, Respiratory Effort, Work of Breathing, Tidal Volume
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition)
Arm Title
Group 2
Arm Type
Other
Arm Description
Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition)
Intervention Type
Device
Intervention Name(s)
High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen
Intervention Description
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%
Primary Outcome Measure Information:
Title
Patient respiratory effort and tidal volume (Vt)
Description
Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography
Time Frame
1h20
Secondary Outcome Measure Information:
Title
Respiratory parameters
Description
respiratory rate (FR bt/min)
Time Frame
"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Title
Respiratory parameters
Description
saturation (SpO2 in %)
Time Frame
"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Title
Respiratory parameters
Description
transcutaneous CO2 pressure (PCO2 in mm Hg)
Time Frame
"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Title
Respiratory parameters
Description
transpulmonary pressure (cm H2O)
Time Frame
"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Title
Hemodynamic parameters
Description
Systolic arterial pressure (PAS in mmHg), Diastolic arterial pressure (PAD in mmHg)
Time Frame
"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Title
Comfort evaluation
Description
comfort evaluation with an visual evaluation scale graduate 0 cm (No discomfort) to 10 cm (maximal discomfort)
Time Frame
"Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minimum age: 18 years
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:
Duration of mechanical ventilation prior to extubation < 24h
Contraindication to NIV
Contraindication to nasogastric tube
Do-not-reintubated order at time of extubation
People under legal protection
Opposition to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud W. THILLE, PUPH
Phone
+33 5 49 44 38 54
Email
arnaud.thille@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Céline DELETAGE
Email
celine.deletage@chu-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud W. THILLE, PUPH
Organizational Affiliation
Medecine intensive reanimation CHU Poitiers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud W THILLE, Pr
Phone
05 49 44 38 54
Email
arnaud.thille@chu-poitiers.fr
Facility Name
Intensive reanimation
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud THILLE
Phone
+33 5 49 44 38 54
First Name & Middle Initial & Last Name & Degree
Jean-Pierre FRAT
Phone
+33 5 49 44 38 54
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33661521
Citation
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.
Results Reference
derived
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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.
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