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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercapnic Respiratory Failure Acute Copd Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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High Flow Nasal Cannula

Group Type EXPERIMENTAL

High flow nasal cannula

Intervention Type DEVICE

HFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%.

Conventional Oxygenation with low flow cannula

Group Type ACTIVE_COMPARATOR

Conventional low flow oxygenation

Intervention Type DEVICE

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

Interventions

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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%.

Intervention Type DEVICE

Conventional low flow oxygenation

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

Intervention Type DEVICE

Other Intervention Names

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High flow oxygenation High flow oxygen therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No