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

Retrospective Cohort Study of Patients With Type II (Hypercapnic) Respiratory Failure Treated With High-flow Oxygen Therapy Versus Non-invasive Ventilation With BiPAP

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 324

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4G2A2
      • Hôpital de Verdun

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

All patients treated for respiratory II failure in the hospital, including patients treated on the general medical floors, in the emergency department, and in the intensive-care unit.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with type II ARF; 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).

Device: Non-Invasive Ventilation; Treatment with Non-Invasive Ventilation by BiPAP. Different BiPAP models are in use. Ventilation parameters set at the discretion of the treating physician.; Other Names: BiPAP; Device: High-Flow Nasal Cannula; Treatment with a High-Flow Nasal Cannula. The Optiflow device by Fisher&Paykel used in all cases. Flow and fraction of inspired oxygen (FiO2) parameters at the discretion of the treating physician.; Other Names: HFNC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hôpital de Verdun
• Investigators: Principal Investigator: Ivan Pavlov, MD, Ivan Pavlov MD CP inc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: COPD; Hypercapnia; Non invasive ventilation; BiPAP; High-Flow Oxygen Therapy; High-Flow Nasal Cannula; Hypercapnic Respiratory failure; Chronic obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Respiration Disorders; Signs and Symptoms, Respiratory; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Respiratory Tract Diseases; Hypercapnia
• Other Study ID Numbers: OF1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No