High Flow Oxygen and Non Invasive Ventilation for Hypercapnic Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypercapnic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard group

NIV alternating with low oxygen therapy at 1 to 4 liters per minute to obtain SpO2 between 88% and 94%.

Group Type ACTIVE_COMPARATOR

standard

Intervention Type DEVICE

patients will receive low flow oxygen therapy at 1 to 4 liters per minute

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.

Group Type EXPERIMENTAL

HFNC

Intervention Type DEVICE

patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions

Interventions

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HFNC

patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions

Intervention Type DEVICE

standard

patients will receive low flow oxygen therapy at 1 to 4 liters per minute

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No