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

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ClinicalTrials.gov Identifier: NCT03443479
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hôpital de Verdun

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.

Condition or disease Intervention/treatment
Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases COPD COPD Exacerbation Pneumonia Chronic Obstructive Pulmonary Disease Device: Non-Invasive Ventilation Device: High-Flow Nasal Cannula

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Treatment with Non-Invasive Ventilation by BiPAP. Different BiPAP models are in use. Ventilation parameters set at the discretion of the treating physician.
Other Name: BiPAP

Device: 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.
Other Name: HFNC




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443479


Contacts
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Contact: Ivan Pavlov, MD 5143621000 ivan.pavlov.md@gmail.com

Locations
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Canada, Quebec
Hôpital de Verdun Recruiting
Montréal, Quebec, Canada, H4G2A2
Contact: Ivan Pavlov, MD    5143621000    ivan.pavlov.md@gmail.com   
Sponsors and Collaborators
Hôpital de Verdun
Investigators
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Principal Investigator: Ivan Pavlov, MD Ivan Pavlov MD CP inc

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Responsible Party: Hôpital de Verdun
ClinicalTrials.gov Identifier: NCT03443479     History of Changes
Other Study ID Numbers: OF1
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hôpital de Verdun:
Non invasive ventilation
BiPAP
High-Flow Oxygen Therapy
High-Flow Nasal Cannula
COPD
Hypercapnia
Hypercapnic Respiratory failure
Chronic obstructive Pulmonary Disease

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pneumonia
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiratory Tract Diseases
Hypercapnia
Respiratory Tract Infections
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms