High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure
Primary Purpose
Hypercapnic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
HFNC
standard
Sponsored by
About this trial
This is an interventional treatment trial for Hypercapnic Respiratory Failure focused on measuring high flow oxygen, non invasive ventilation, hypercapnic respiratory failure
Eligibility Criteria
Inclusion Criteria:
- Patients aged more than 18 years with a diagnosis of acute-on-chronic respiratory failure and respiratory acidosis requiring NIV.
Exclusion Criteria:
- Patient included in another study
- Patients intubated at ICU admission or within 12 hours
- Contraindication to NIV including: pneumothorax, Hemodynamic instability, GCS less than 12, facial malformation
- Asthma
- A do not intubate order
- Neuromuscular disease
Sites / Locations
- Intensive Care UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard group
HFNC group
Arm Description
NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.
NIV alternating with HFNC delivering the equivalent inspired fraction of oxygen (FiO2) with a flow at 30 to 60 liters/min through an Optiflow nasal interface.
Outcomes
Primary Outcome Measures
duration of NIV
number of days patients received NIV, and for patients with home NIV: it is the number of days spent to achieve the usual daily NIV hours with clinical and gasometric stability
Secondary Outcome Measures
Time to obtain NIV withdrawal criteria
the day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH <7.36)
NIV failure
need for intubation or death
ICU length of stay
number of days spent in the ICU for this episode of exacerbation
ICU Mortality
death in the ICU during the recorded episode
Full Information
NCT ID
NCT03627598
First Posted
August 4, 2018
Last Updated
August 8, 2018
Sponsor
University Hospital, Mahdia
1. Study Identification
Unique Protocol Identification Number
NCT03627598
Brief Title
High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure
Official Title
High Flow Nasal Oxygen in Addition to Non Invasive Ventilation During Hypercapnic Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Mahdia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
this study evaluates high flow oxygen therapy in addition to non invasive ventilation (NIV) to treat hypercapnic respiratory failure. Between sessions of NIV, half of participants will have high flow nasal cannula while the others will have standard low flow oxygen therapy.
Detailed Description
High Flow Nasal Cannula (HFNC) is a new way of oxygen therapy that has gained interest in the management of patients with acute respiratory failure. It allows reaching a high flow air up to 60 liters / min via a nasal cannula with a humidification and warming of the air administered. It has a number of physiological effects such as wash out of anatomical dead space, generation of a small PEEP and high inspired fraction of oxygen which enhances compliance and reduces inspiratory efforts.
NIV is the corner stone in the treatment of severe COPD exacerbation. Nevertheless, prolonged application of the facial mask expose to local complications and intolerance which can be a cause of failure, so reducing the duration of exposure to this procedure is important.
The role of HFNC in supplementing NIV effect during hypercapnic respiratory failure has not been assessed. Much of the data available on HFNC are about hypoxemic respiratory failure.
Because of its physiological effects, it can be hypothesized that HFNC in addition to NIV can shorten its duration by facilitating carbon dioxide clearance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure
Keywords
high flow oxygen, non invasive ventilation, hypercapnic respiratory failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard group
Arm Type
Active Comparator
Arm Description
NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.
Arm Title
HFNC group
Arm Type
Experimental
Arm Description
NIV alternating with HFNC delivering the equivalent inspired fraction of oxygen (FiO2) with a flow at 30 to 60 liters/min through an Optiflow nasal interface.
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions
Intervention Type
Device
Intervention Name(s)
standard
Intervention Description
patients will receive low flow oxygen therapy at 1 to 4 liters per minute
Primary Outcome Measure Information:
Title
duration of NIV
Description
number of days patients received NIV, and for patients with home NIV: it is the number of days spent to achieve the usual daily NIV hours with clinical and gasometric stability
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Time to obtain NIV withdrawal criteria
Description
the day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH <7.36)
Time Frame
28 days
Title
NIV failure
Description
need for intubation or death
Time Frame
28 days
Title
ICU length of stay
Description
number of days spent in the ICU for this episode of exacerbation
Time Frame
28 days
Title
ICU Mortality
Description
death in the ICU during the recorded episode
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged more than 18 years with a diagnosis of acute-on-chronic respiratory failure and respiratory acidosis requiring NIV.
Exclusion Criteria:
Patient included in another study
Patients intubated at ICU admission or within 12 hours
Contraindication to NIV including: pneumothorax, Hemodynamic instability, GCS less than 12, facial malformation
Asthma
A do not intubate order
Neuromuscular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nejla Tilouche, MD
Phone
0021623277911
Email
tilouche.nejla@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
souheil elatrous, MD
Phone
0021698403053
Email
souheilatrous@gmail.com
Facility Information:
Facility Name
Intensive Care Unit
City
Mahdia
ZIP/Postal Code
5100
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nejla Tilouche, MD
Phone
0021623277911
Email
tilouche.nejla@gmail.com
First Name & Middle Initial & Last Name & Degree
souheil Elatrous, MD
Phone
0021698403053
Email
souheilatrous@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26947372
Citation
Lepere V, Messika J, La Combe B, Ricard JD. High-flow nasal cannula oxygen supply as treatment in hypercapnic respiratory failure. Am J Emerg Med. 2016 Sep;34(9):1914.e1-2. doi: 10.1016/j.ajem.2016.02.020. Epub 2016 Feb 12. No abstract available.
Results Reference
background
PubMed Identifier
25981908
Citation
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
Results Reference
result
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High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure
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