An interventional study of High flow nasal cannula and Conventional low flow oxygenation in Hypercapnic Respiratory Failure and Acute Copd Exacerbation, sponsored by Hôpital de Verdun. Status unknown at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Hôpital de Verdun · Not applicable, Interventional, and Treatment
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 84 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Hôpital de Verdun is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: High flow nasal cannula
Device: Conventional low flow oxygenation
HFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%.
Also known as: High flow oxygenation, High flow oxygen therapy
Conventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%.
Proportion of patients progressing to NIV in each cohort
Time frame: 6 hours
Venous blood gas PCO2
Time frame: 1 hour, 6 hours, and 24 hours
Venous blood gas pH
Time frame: 1 hour, 6 hours, and 24 hours
Respiratory rate
Number of breaths per minute, as documented in the medical chart
Time frame: 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
Time frame: 1 hour, 6 hours, 24 hours, and daily until study completion
Mean arterial pressure
Mean arterial pressure, as documented in the medical chart
Time frame: 1 hour, 6 hours, 24 hours, and daily until study completion
Incidence of intubation
Time frame: Up to 90 days after enrolment, or until hospital discharge
Admission to the intensive care unit
Time frame: Up to 90 days after enrolment, or until hospital discharge
In-hospital mortality
Time frame: Up to 90 days after enrolment, or until hospital discharge
Intensive care unit length of stay
Time frame: Up to 90 days after enrolment, or until discharge from the intensive care unit
Hospital length of stay
Time frame: Up to 90 days after enrolment, or until hospital discharge
Patient comfort
Level of comfort assessed on a visual analogue scale by the patient
Time frame: 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
Time frame: 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Hôpital de Verdun