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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443479
• Other study ID #: OF1
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2020
• Source: Hôpital de Verdun
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• COPD Exacerbation
• Hypercapnia
• Lung Diseases
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Valve Insufficiency
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Hôpital de Verdun	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital de Verdun

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Death at 48h	Mortality in the 48h following the initial intervention	48 hours post intervention
Secondary	Mortality at 7d	Incidence of death in the 7 days after intervention	7 days post intervention
Secondary	Incidence of endotracheal intubation	The incidence of intubation	For the whole length of hospital stay, up to a maximum of one year.
Secondary	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.
Secondary	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.
Secondary	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.