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

Sponsor

Hôpital de Verdun (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05497986

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercapnic Respiratory Failure Acute Copd Exacerbation	Device: High flow nasal cannula Device: Conventional low flow oxygenation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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%.

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%.

Outcome Measures

Primary Outcome Measures

Proportion of patients progressing to NIV in each cohort [6 hours]

Secondary Outcome Measures

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]
Number of breaths per minute, as documented in the medical chart
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
Mean arterial pressure [1 hour, 6 hours, 24 hours, and daily until study completion]
Mean arterial pressure, as documented in the medical chart
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 [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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CISSS-de-la-Montérégie-Centre	Longueuil	Quebec	Canada	J4V 2H2
2	CIUSSS de l'Est-de-l'ïle-de-Montréal	Montréal	Quebec	Canada	H1T 2M4
3	Hôpital de Verdun	Montréal	Quebec	Canada	H4G2A2