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NCT Number: NCT03443479

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

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.

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Key information

Conditions

Respiratory Failure COPD COPD Exacerbation Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Hypercapnia Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de Verdun

Montreal, Quebec, H4G2A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive ventilation

Device

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

High-flow nasal cannula

Device

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

Primary outcomes

  1. Failure of initial treatment (combined outcome)

    Time frame: 48 hours post intervention

    Combined outcome of death or intubation or transition to another treatment modality or unplanned resumption of respiratory support

  2. Death at 48h

    Time frame: 48 hours post intervention

    Mortality in the 48h following the initial intervention

Secondary outcomes

  1. Mortality at 7d

    Time frame: 7 days post intervention

    Incidence of death in the 7 days after intervention

  2. Incidence of endotracheal intubation

    Time frame: For the whole length of hospital stay, up to a maximum of one year.

    The incidence of intubation

  3. Length of stay

    Time frame: For the whole length of hospital stay, up to a maximum of one year.

    Duration of stay in the hospital, in days

  4. Duration of endotracheal intubation

    Time frame: 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

  5. Incidence of intervention change

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hôpital de Verdun

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2018
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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