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

NCT03443479 — Completed, 324 participants, Hôpital de Verdun

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

RegistryNCT03443479
StatusCompleted
Study typeObservational
Enrollment324 (Actual)
SponsorHôpital de Verdun (Other)
ConditionsRespiratory Failure, Respiratory Insufficiency, Respiratory Tract Diseases, COPD, COPD Exacerbation, Pneumonia, Chronic Obstructive Pulmonary Disease
InterventionsNon-Invasive Ventilation, High-Flow Nasal Cannula (Device)
Datesstart 2015-04-01, primary completion 2019-07-01, completion 2019-07-01, first posted 2018-02-23, last updated 2020-07-28
Locations1 site in Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Respiratory Failure All trials for Respiratory Insufficiency All trials of Non-Invasive Ventilation All trials of High-Flow Nasal Cannula

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Patients with type II ARFDevice: Non-Invasive Ventilation; Device: High-Flow Nasal CannulaAll 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).
  • Non-Invasive Ventilation (Device), also known as BiPAP: Treatment with Non-Invasive Ventilation by BiPAP. Different BiPAP models are in use. Ventilation parameters set at the discretion of the treating physician.
  • High-Flow Nasal Cannula (Device), also known as HFNC: 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.

+Outcome measures

Primary outcomes

  • Failure of initial treatment (combined outcome) [48 hours post intervention]: Combined outcome of death or intubation or transition to another treatment modality or unplanned resumption of respiratory support
  • Death at 48h [48 hours post intervention]: Mortality in the 48h following the initial intervention

Secondary outcomes

  • Mortality at 7d [7 days post intervention]: Incidence of death in the 7 days after intervention
  • Incidence of endotracheal intubation [For the whole length of hospital stay, up to a maximum of one year.]: The incidence of intubation
  • Length of stay [For the whole length of hospital stay, up to a maximum of one year.]: Duration of stay in the hospital, in days
  • Duration of endotracheal intubation [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
  • Incidence of intervention change [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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Hôpital de VerdunMontreal, QuebecCanada

+Investigators