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

NCT05497986 | Unknown DMC

• 1 other identifier: Verdun2022_01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypercapnic Respiratory Failure; Acute Copd Exacerbation

Keywords

High Flow Nasal Cannula; High Flow Nasal Insufflation; High Flow Oxygen Therapy; High Flow Oxygenation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients progressing to NIV in each cohort

  6 hours

Secondary Outcomes (12)

• Venous blood gas PCO2

  1 hour, 6 hours, and 24 hours

• Venous blood gas pH

  1 hour, 6 hours, and 24 hours

• Respiratory rate

  1 hour, 6 hours, 24 hours, and daily until study completion

• Heart rate

  1 hour, 6 hours, 24 hours, and daily until study completion

• Mean arterial pressure

  1 hour, 6 hours, 24 hours, and daily until study completion

Study Arms (2)

High Flow Nasal Cannula

EXPERIMENTAL

Device: High flow nasal cannula

Conventional Oxygenation with low flow cannula

ACTIVE COMPARATOR

Device: Conventional low flow oxygenation

Interventions

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%.

Also known as: High flow oxygenation, High flow oxygen therapy

High Flow Nasal Cannula

Conventional low flow oxygenation DEVICE

Conventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%.

Conventional Oxygenation with low flow cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital de Verdun: lead

Study Sites (3)

CISSS-de-la-Montérégie-Centre

Longueuil, Quebec, J4V 2H2, Canada

Location

CIUSSS de l'Est-de-l'ïle-de-Montréal

Montreal, Quebec, H1T 2M4, Canada

Location

Hôpital de Verdun

Montreal, Quebec, H4G2A2, Canada

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ivan Pavlov, M.D.

  CIUSSS-Centre-Sud-de-l'Île-de-Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Pavlov, M.D

CONTACT

514-362-1000; ivan.pavlov.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: October 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (3)