Comparison of High-flow Oxygen vs. BiPAP in Type II (Hypercapnic) Respiratory Failure

Completed

• Conditions: Respiratory Failure; COPD Exacerbation; Pneumonia; Respiratory Tract Diseases; Respiratory Insufficiency; COPD; Chronic Obstructive Pulmonary Disease
• Interventions: Device: Non-Invasive Ventilation; Device: High-Flow Nasal Cannula

• Registration Number: NCT03443479
• Lead Sponsor: Hôpital de Verdun

Brief Summary

A retrospective cohort study of all patients treated for type II (hypercapnic) respiratory failure with either High-Flow Oxygen Therapy or Non-Invasive Ventilation in a general adult hospital.

Detailed Description

We will compare various clinically relevant outcomes in patients treated for type II (hypercapnic) acute respiratory failure (ARF) with either High-Flow Nasal Cannula (HFNC) or Non-Invasive Ventilation (NIV) in a general adult hospital.

All patients treated with HFNC were treated with an Optiflow device (Fisher\&Paykel). Various Bilevel positive airway pressure (BiPAP) devices were used during the study period.

All ventilatory parameters were set according to the treating physicians' preferences.

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-23
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• All patients treated with respiratory failure not responding to conventional supplemental oxygen therapy
• Blood venous gas showing partial pressure of carbon dioxide>50 mmHg before beginning therapy with either NIV or HFNC

Exclusion Criteria

• Lack of records of the primary outcome
• End-of-life care
• Lack of gas before the beginning of NIV or HFNC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with type II ARF	High-Flow Nasal Cannula	All patients with type II respiratory failure that were deemed by the treating physician to require ventilatory support either with non-invasive ventilation (NIV) or High-Flow Nasal Cannula (HFNC).
Patients with type II ARF	Non-Invasive Ventilation	All patients with type II respiratory failure that were deemed by the treating physician to require ventilatory support either with non-invasive ventilation (NIV) or High-Flow Nasal Cannula (HFNC).

Primary Outcome Measures

Name	Time	Method
Failure of initial treatment (combined outcome)	48 hours post intervention	Combined outcome of death or intubation or transition to another treatment modality or unplanned resumption of respiratory support
Death at 48h	48 hours post intervention	Mortality in the 48h following the initial intervention

Secondary Outcome Measures

Name	Time	Method
Incidence of endotracheal intubation	For the whole length of hospital stay, up to a maximum of one year.	The incidence of intubation
Length of stay	For the whole length of hospital stay, up to a maximum of one year.	Duration of stay in the hospital, in days
Mortality at 7d	7 days post intervention	Incidence of death in the 7 days after intervention
Duration of endotracheal intubation	For the whole length of hospital stay, up to a maximum of one year.	Duration (in hours) of the first episode of endotracheal intubation, immediately following the failed intervention
Incidence of intervention change	For the whole length of hospital stay, up to a maximum of one year.	The incidence of patients who switch from Non-Invasive Ventilation to High-Flow Oxygen, and vice versa, due to treatment failure

Trial Locations

Locations (1)

Hôpital de Verdun; 🇨🇦 Montréal, Quebec, Canada