NCT03443479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

4.3 years

First QC Date

February 15, 2018

Last Update Submit

July 27, 2020

Conditions

Respiratory FailureRespiratory InsufficiencyRespiratory Tract DiseasesCOPDCOPD ExacerbationPneumoniaChronic Obstructive Pulmonary Disease

Keywords

Non invasive ventilationBiPAPHigh-Flow Oxygen TherapyHigh-Flow Nasal CannulaCOPDHypercapniaHypercapnic Respiratory failureChronic obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Mortality at 7d

    7 days post intervention

  • Incidence of endotracheal intubation

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

  • Length of stay

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

  • Duration of endotracheal intubation

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

  • Incidence of intervention change

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

Study Arms (1)

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 VentilationDevice: High-Flow Nasal Cannula

Interventions

Non-Invasive VentilationDEVICE

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
Patients with type II ARF
High-Flow Nasal CannulaDEVICE

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
Patients with type II ARF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de Verdun

Montreal, Quebec, H4G2A2, Canada

Location

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Tract DiseasesPulmonary Disease, Chronic ObstructivePneumoniaHypercapnia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Ivan Pavlov, MD

    Ivan Pavlov MD CP inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 23, 2018

Study Start

April 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)