Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure

Not Applicable

• Conditions: Hypercapnic Respiratory Failure; Acute Copd Exacerbation
• Interventions: Device: Conventional low flow oxygenation; Device: High flow nasal cannula

• Registration Number: NCT05497986
• Lead Sponsor: Hôpital de Verdun

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-11
• Study Start: 2022-10
• Primary Completion: 2024-01
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Oxygenation with low flow cannula	Conventional low flow oxygenation	-
High Flow Nasal Cannula	High flow nasal cannula	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients progressing to NIV in each cohort	6 hours

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	1 hour, 6 hours, 24 hours, and daily until study completion	Mean arterial pressure, as documented in the medical chart
Admission to the intensive care unit	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
Respiratory rate	1 hour, 6 hours, 24 hours, and daily until study completion	Number of breaths per minute, as documented in the medical chart
In-hospital mortality	Up to 90 days after enrolment, or until hospital discharge
Venous blood gas PCO2	1 hour, 6 hours, and 24 hours
Heart rate	1 hour, 6 hours, 24 hours, and daily until study completion	Number of heart beats per minute, as documented in the medical chart
Patient comfort	1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days	Level of comfort assessed on a visual analogue scale by the patient
Venous blood gas pH	1 hour, 6 hours, and 24 hours
Incidence of intubation	Up to 90 days after enrolment, or until hospital discharge
Shortness of breath	1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days	Severity of the shortness of breath assessed on a visual analogue scale by the patient

Trial Locations

Locations (3)

Hôpital de Verdun; 🇨🇦 Montréal, Quebec, Canada

CISSS-de-la-Montérégie-Centre; 🇨🇦 Longueuil, Quebec, Canada

CIUSSS de l'Est-de-l'ïle-de-Montréal; 🇨🇦 Montréal, Quebec, Canada