ClinicalTrials.gg
CompletedNCT03443479Updated Jul 28, 2020

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

An observational study in Respiratory Failure, Respiratory Insufficiency and Respiratory Tract Diseases, sponsored by Hôpital de Verdun. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by Hôpital de Verdun · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
324
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Respiratory Insufficiency

1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.

This study's enrollment of 324 is above the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Hôpital de Verdun is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Lack of records of the primary outcome
  • End-of-life care
  • Lack of gas before the beginning of NIV or HFNC
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
324 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Device: High-Flow Nasal Cannula

Interventions

  • DeviceNon-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.

    Also known as: BiPAP

  • DeviceHigh-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.

    Also known as: HFNC

06

What researchers measure

Primary outcomes

  1. Failure of initial treatment (combined outcome)

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

    Time frame: 48 hours post intervention

  2. Death at 48h

    Mortality in the 48h following the initial intervention

    Time frame: 48 hours post intervention

Secondary outcomes

  1. Mortality at 7d

    Incidence of death in the 7 days after intervention

    Time frame: 7 days post intervention

  2. Incidence of endotracheal intubation

    The incidence of intubation

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

  3. Length of stay

    Duration of stay in the hospital, in days

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

  4. Duration of endotracheal intubation

    Duration (in hours) of the first episode of endotracheal intubation, immediately following the failed intervention

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

  5. 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

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

07

Study locations

1 site
  • Hôpital de Verdun
    Montréal, Quebec H4G2A2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2015 to primary completion in Jul 2019, 51 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2018
First posted
Feb 23, 2018
StartActual
Apr 1, 2015
Primary completionActual
Jul 1, 2019
CompletionActual
Jul 1, 2019
Last update
Jul 28, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03443479
Lead sponsor
Hôpital de Verdun
Responsible party
Sponsor
First posted
Feb 23, 2018
Start date
Apr 1, 2015
Primary completion
Jul 1, 2019
Completion
Jul 1, 2019
Last update
Jul 28, 2020

Study contacts

Ivan Pavlov, MD
principal investigator · Ivan Pavlov MD CP inc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion