Back to resultsPos -Extubation High Flow Nasal Cannula
Primary Purpose
Respiratory Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High flow nasal cannula
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Insufficiency
Eligibility Criteria
Inclusion Criteria:
- respiratory failure type I and Type II
Exclusion Criteria:
- Mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
High flow nasal cannula
Conventional oxygen
Arm Description
A device og high flow nasal cannula giving 60 litres / min
Nasal cannula giving oxygen up to 10 litres / minute
Outcomes
Primary Outcome Measures
Number of participants with post extubation respiratory failure
Number of participants with post extubation hypoxemia with or without hypercapnea
Secondary Outcome Measures
Rate of ICU stay and mortality
Duration of ICU stay and incidence of mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04441736
Brief Title
Pos -Extubation High Flow Nasal Cannula
Official Title
Post Extubation High Flow Nasal Cannula Versus Conventional Oxygen Therapy in Extubation Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
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
comparing high flow nasal cannula & conventional oxygen tharapy in post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU outcome &28 days mortality
Detailed Description
patients with respiratory failure either type I or type II planned for extubation will be divided into 2 groups post extubation :
Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute group II: will receive nasal cannula up to 10 litres / minute
Data of the patients will be collected for 28 days postextubation and analysed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High flow nasal cannula
Arm Type
Active Comparator
Arm Description
A device og high flow nasal cannula giving 60 litres / min
Arm Title
Conventional oxygen
Arm Type
Placebo Comparator
Arm Description
Nasal cannula giving oxygen up to 10 litres / minute
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
Device gives high flow oxygen comparable to non invasive ventilation
Primary Outcome Measure Information:
Title
Number of participants with post extubation respiratory failure
Description
Number of participants with post extubation hypoxemia with or without hypercapnea
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Rate of ICU stay and mortality
Description
Duration of ICU stay and incidence of mortality
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
respiratory failure type I and Type II
Exclusion Criteria:
Mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Nassar, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Giza
ZIP/Postal Code
11345
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Pos -Extubation High Flow Nasal Cannula
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