Clinical trial NCT03443479: Comparison of High-flow Oxygen vs. BiPAP in Type II (Hypercapnic) Respiratory Failure
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Respiratory Insufficiency
Respiratory Tract Diseases
COPD
COPD Exacerbation
Pneumonia
Chronic Obstructive Pulmonary Disease
Keywords: Non invasive ventilation
BiPAP
High-Flow Oxygen Therapy
High-Flow Nasal Cannula
COPD
Hypercapnia
Hypercapnic Respiratory failure
Chronic obstructive Pulmonary Disease
Lead sponsor: Hôpital de Verdun
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure of initial treatment (combined outcome)
timeFrame: 48 hours post intervention
measure: Death at 48h
timeFrame: 48 hours post intervention
Secondary outcomes:
measure: Mortality at 7d
timeFrame: 7 days post intervention
measure: Incidence of endotracheal intubation
timeFrame: For the whole length of hospital stay, up to a maximum of one year.
measure: Length of stay
timeFrame: For the whole length of hospital stay, up to a maximum of one year.
measure: Duration of endotracheal intubation
timeFrame: For the whole length of hospital stay, up to a maximum of one year.
measure: Incidence of intervention change
timeFrame: For the whole length of hospital stay, up to a maximum of one year.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital de Verdun
state: Quebec
Study officials:
affiliation: Ivan Pavlov MD CP inc
name: Ivan Pavlov, MD
role: PRINCIPAL_INVESTIGATOR
References: