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Current evidence suggests a mechanistic and physiological rationale for the use of high flow nasal cannula (HFNC) in acute respiratory hypoxemic failure (AHRF) based on physiological studies in airway models, healthy volunteers and patients with Chronic Obstructive Respiratory Disease (COPD). This is supported by observational studies in patients with AHRF with reductions in a range of respiratory and other physiological parameters. Observational studies also suggest similar intubation rates and lower failure rates with HFNC when compared to non-invasive ventilation (NIV) with improved patient acceptance and tolerance for HFNC.
The role of HFNC is less clear in acute hypercapnic respiratory failure. Although non-invasive ventilation is the recommended treatment, it is associated with discomfort, and a significant proportion (up to 25% in some reports) cannot tolerate non-invasive ventilation. Observational reports and limited data from randomized controlled trials suggests that HFNC is effective in treating patients with hypercapnic respiratory failure.
We designed this trial to assess whether early application of HFNC in patients with non-severe hypercapnic respiratory failure can correct barometric abnormalities, and prevent progression to non-invasive ventilation or tracheal intubation and mechanical ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Nasal Cannula | Experimental |
| |
| Conventional Oxygenation with low flow cannula | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal cannula | Device | HFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients progressing to NIV in each cohort | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Venous blood gas PCO2 | 1 hour, 6 hours, and 24 hours | |
| Venous blood gas pH | 1 hour, 6 hours, and 24 hours | |
| Respiratory rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Pavlov, M.D | Contact | 514-362-1000 | 63525 | ivan.pavlov.md@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ivan Pavlov, M.D. | CIUSSS-Centre-Sud-de-l'Île-de-Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CISSS-de-la-Montérégie-Centre | Longueuil | Quebec | J4V 2H2 | Canada |
Data may be shared to researchers who will request it, based on reasonable research objectives, ethical approval if needed, and signing of a data sharing agreement by the relevant institutions.
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Due to the nature of the intervention, nor the participants, nor the treating physicians, nor the investigator can be blinded. However, the outcomes will be analyzed an independent statistician blinded to the treatment assignments.
|
| Conventional low flow oxygenation | Device | Conventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%. |
|
Number of breaths per minute, as documented in the medical chart |
| 1 hour, 6 hours, 24 hours, and daily until study completion |
| Heart rate | Number of heart beats per minute, as documented in the medical chart | 1 hour, 6 hours, 24 hours, and daily until study completion |
| Mean arterial pressure | Mean arterial pressure, as documented in the medical chart | 1 hour, 6 hours, 24 hours, and daily until study completion |
| Incidence of intubation | Up to 90 days after enrolment, or until hospital discharge |
| Admission to the intensive care unit | Up to 90 days after enrolment, or until hospital discharge |
| In-hospital mortality | Up to 90 days after enrolment, or until hospital discharge |
| Intensive care unit length of stay | Up to 90 days after enrolment, or until discharge from the intensive care unit |
| Hospital length of stay | Up to 90 days after enrolment, or until hospital discharge |
| Patient comfort | Level of comfort assessed on a visual analogue scale by the patient | 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days |
| Shortness of breath | Severity of the shortness of breath assessed on a visual analogue scale by the patient | 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days |
| CIUSSS de l'Est-de-l'ïle-de-Montréal | Montreal | Quebec | H1T 2M4 | Canada |
|
| Hôpital de Verdun | Montreal | Quebec | H4G2A2 | Canada |