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
|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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
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
- 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
- Death at 48h [ Time Frame: 48 hours post intervention ]Mortality in the 48h following the initial intervention
- Mortality at 7d [ Time Frame: 7 days post intervention ]Incidence of death in the 7 days after intervention
- Incidence of endotracheal intubation [ Time Frame: For the whole length of hospital stay, up to a maximum of one year. ]The incidence of intubation
- 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
- 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
- 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
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
|Contact: Ivan Pavlov, MDfirstname.lastname@example.org|
|Hôpital de Verdun||Recruiting|
|Montréal, Quebec, Canada, H4G2A2|
|Contact: Ivan Pavlov, MD 5143621000 email@example.com|
|Principal Investigator:||Ivan Pavlov, MD||Ivan Pavlov MD CP inc|