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

H

Hôpital de Verdun

Status

Not yet enrolling

Conditions

Acute Copd Exacerbation
Hypercapnic Respiratory Failure

Treatments

Device: Conventional low flow oxygenation
Device: High flow nasal cannula

Study type

Interventional

Funder types

Other

Identifiers

NCT05497986
Verdun2022_01

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

High Flow Nasal Cannula
Experimental group
Treatment:
Device: High flow nasal cannula
Conventional Oxygenation with low flow cannula
Active Comparator group
Treatment:
Device: Conventional low flow oxygenation

Trial contacts and locations

3

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Central trial contact

Ivan Pavlov, M.D

Data sourced from clinicaltrials.gov

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