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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypercapnic Respiratory Failure; Acute Copd Exacerbation
• Intervention / Treatment: Device: High flow nasal cannula; Device: Conventional low flow oxygenation

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Pavlov, M.D; Phone Number: 63525 514-362-1000; Email: ivan.pavlov.md@gmail.com

Study Locations

• Canada
  • Quebec
    • Longueuil, Quebec, Canada, J4V 2H2
      • CISSS-de-la-Montérégie-Centre
      • Contact: Valérie Langlois-Carbonneau, M.D.
    • Montréal, Quebec, Canada, H4G2A2
      • Hôpital de Verdun
    • Montréal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'Est-de-l'Île-de-Montréal
      • Contact: Massimiliano Iseppon, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High Flow Nasal Cannula	Device: High flow nasal cannula; HFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%.; Other Names: High flow oxygenation; High flow oxygen therapy
ACTIVE_COMPARATOR: Conventional Oxygenation with low flow cannula	Device: Conventional low flow oxygenation; Conventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients progressing to NIV in each cohort	6 hours

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hôpital de Verdun
• Investigators: Principal Investigator: Ivan Pavlov, M.D., CIUSSS-Centre-Sud-de-l'Île-de-Montréal

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (ACTUAL): August 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: High Flow Nasal Cannula; High Flow Oxygenation; High Flow Nasal Insufflation; High Flow Oxygen Therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: Verdun2022_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No