High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure

High Flow Nasal Oxygen in Addition to Non Invasive Ventilation During Hypercapnic Respiratory Failure

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.

Study Overview

• Status: Unknown
• Conditions: Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: standard; Device: HFNC

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nejla Tilouche, MD; Phone Number: 0021623277911; Email: tilouche.nejla@gmail.com
• Study Contact Backup: Name: souheil Elatrous, MD; Phone Number: 0021698403053; Email: souheilatrous@gmail.com

Study Locations

• Tunisia
  • Mahdia, Tunisia, 5100
    • Recruiting
    • Intensive care unit
    • Contact: Nejla Tilouche, MD; Phone Number: 0021623277911; Email: tilouche.nejla@gmail.com
    • Contact: souheil Elatrous, MD; Phone Number: 0021698403053; Email: souheilatrous@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: standard group; NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.	Device: standard; patients will receive low flow oxygen therapy at 1 to 4 liters per minute
EXPERIMENTAL: HFNC group; 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.	Device: HFNC; patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to obtain NIV withdrawal criteria	the day patients do not have signs of acute respiratory failure and no respiratory acidosis (pH <7.36)	28 days
NIV failure	need for intubation or death	28 days
ICU length of stay	number of days spent in the ICU for this episode of exacerbation	28 days
ICU Mortality	death in the ICU during the recorded episode	28 days

Collaborators and Investigators

• Sponsor: University Hospital, Mahdia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: August 4, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (ACTUAL): August 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: non invasive ventilation; hypercapnic respiratory failure; high flow oxygen
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: 140284

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No