Clinical trial NCT05497986: Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure
Official title: Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercapnic Respiratory Failure
Acute Copd Exacerbation
Keywords: High Flow Nasal Cannula
High Flow Nasal Insufflation
High Flow Oxygen Therapy
High Flow Oxygenation
Lead sponsor: Hôpital de Verdun
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients \> 18 years of age
* Acute Hypercapnic respiratory failure with pH \< 7.35 and pCO2 \> 45 mmHg

Exclusion Criteria:

* Pregnant or Breast-Feeding
* Patients who cannot read and understand French or English
* Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
* Hypercapnia secondary to exacerbation of asthma
* Contraindication to NIV
* Contraindication to HFNC
* Not for escalation to NIV based on a ceiling of care
* pH \< 7.15
* GCS 8 or less
* Shock defined as systolic \< 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation
* Respiratory or cardio-respiratory arrest
* Any other indication that requires immediate invasive/non-invasive mechanical ventilation

Primary outcomes:
measure: Proportion of patients progressing to NIV in each cohort
timeFrame: 6 hours
Secondary outcomes:
measure: Venous blood gas PCO2
timeFrame: 1 hour, 6 hours, and 24 hours
measure: Venous blood gas pH
timeFrame: 1 hour, 6 hours, and 24 hours
measure: Respiratory rate
timeFrame: 1 hour, 6 hours, 24 hours, and daily until study completion
measure: Heart rate
timeFrame: 1 hour, 6 hours, 24 hours, and daily until study completion
measure: Mean arterial pressure
timeFrame: 1 hour, 6 hours, 24 hours, and daily until study completion
measure: Incidence of intubation
timeFrame: Up to 90 days after enrolment, or until hospital discharge
measure: Admission to the intensive care unit
timeFrame: Up to 90 days after enrolment, or until hospital discharge
measure: In-hospital mortality
timeFrame: Up to 90 days after enrolment, or until hospital discharge
measure: Intensive care unit length of stay
timeFrame: Up to 90 days after enrolment, or until discharge from the intensive care unit
measure: Hospital length of stay
timeFrame: Up to 90 days after enrolment, or until hospital discharge
measure: Patient comfort
timeFrame: 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
measure: Shortness of breath
timeFrame: 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
Other outcomes:
Locations:
city: Longueuil
country: Canada
facility: CISSS-de-la-Montérégie-Centre
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS de l'Est-de-l'ïle-de-Montréal
state: Quebec
city: Montréal
country: Canada
facility: Hôpital de Verdun
state: Quebec
Study officials:
affiliation: CIUSSS-Centre-Sud-de-l'Île-de-Montréal
name: Ivan Pavlov, M.D.
role: PRINCIPAL_INVESTIGATOR
References: