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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
University Hospital, Mahdia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 4, 2018
Last Updated
August 8, 2018
Sponsor
University Hospital, Mahdia
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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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