High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure

Not Applicable

• Conditions: Hypercapnic Respiratory Failure
• Interventions: Device: standard; Device: HFNC

• Registration Number: NCT03627598
• Lead Sponsor: University Hospital, Mahdia

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.

Study Timeline

• Study Start: 2018-07-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-04
• Study First Submitted QC: 2018-08-08
• Last Update Submitted: 2018-08-08
• Study First Posted: 2018-08-13
• Last Update Posted: 2018-08-13
• Primary Completion: 2019-08
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard group	standard	NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.
HFNC group	HFNC	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.

Primary Outcome Measures

Name	Time	Method
duration of NIV	28 days	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

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

Trial Locations

Locations (1)

Intensive Care Unit; 🇹🇳 Mahdia, Tunisia