search
Back to results

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

Primary Purpose

Hypercapnic Respiratory Failure, Acute Copd Exacerbation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High flow nasal cannula
Conventional low flow oxygenation
Sponsored by
Hôpital de Verdun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercapnic Respiratory Failure focused on measuring High Flow Nasal Cannula, High Flow Nasal Insufflation, High Flow Oxygen Therapy, High Flow Oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CISSS-de-la-Montérégie-Centre
  • CIUSSS de l'Est-de-l'ïle-de-Montréal
  • Hôpital de Verdun

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Flow Nasal Cannula

Conventional Oxygenation with low flow cannula

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients progressing to NIV in each cohort

Secondary Outcome Measures

Venous blood gas PCO2
Venous blood gas pH
Respiratory rate
Number of breaths per minute, as documented in the medical chart
Heart rate
Number of heart beats per minute, as documented in the medical chart
Mean arterial pressure
Mean arterial pressure, as documented in the medical chart
Incidence of intubation
Admission to the intensive care unit
In-hospital mortality
Intensive care unit length of stay
Hospital length of stay
Patient comfort
Level of comfort assessed on a visual analogue scale by the patient
Shortness of breath
Severity of the shortness of breath assessed on a visual analogue scale by the patient

Full Information

First Posted
August 8, 2022
Last Updated
August 9, 2022
Sponsor
Hôpital de Verdun
search

1. Study Identification

Unique Protocol Identification Number
NCT05497986
Brief Title
Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure
Official Title
Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital de Verdun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure, Acute Copd Exacerbation
Keywords
High Flow Nasal Cannula, High Flow Nasal Insufflation, High Flow Oxygen Therapy, High Flow Oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Flow Nasal Cannula
Arm Type
Experimental
Arm Title
Conventional Oxygenation with low flow cannula
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Other Intervention Name(s)
High flow oxygenation, High flow oxygen therapy
Intervention Description
HFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%.
Intervention Type
Device
Intervention Name(s)
Conventional low flow oxygenation
Intervention Description
Conventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%.
Primary Outcome Measure Information:
Title
Proportion of patients progressing to NIV in each cohort
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Venous blood gas PCO2
Time Frame
1 hour, 6 hours, and 24 hours
Title
Venous blood gas pH
Time Frame
1 hour, 6 hours, and 24 hours
Title
Respiratory rate
Description
Number of breaths per minute, as documented in the medical chart
Time Frame
1 hour, 6 hours, 24 hours, and daily until study completion
Title
Heart rate
Description
Number of heart beats per minute, as documented in the medical chart
Time Frame
1 hour, 6 hours, 24 hours, and daily until study completion
Title
Mean arterial pressure
Description
Mean arterial pressure, as documented in the medical chart
Time Frame
1 hour, 6 hours, 24 hours, and daily until study completion
Title
Incidence of intubation
Time Frame
Up to 90 days after enrolment, or until hospital discharge
Title
Admission to the intensive care unit
Time Frame
Up to 90 days after enrolment, or until hospital discharge
Title
In-hospital mortality
Time Frame
Up to 90 days after enrolment, or until hospital discharge
Title
Intensive care unit length of stay
Time Frame
Up to 90 days after enrolment, or until discharge from the intensive care unit
Title
Hospital length of stay
Time Frame
Up to 90 days after enrolment, or until hospital discharge
Title
Patient comfort
Description
Level of comfort assessed on a visual analogue scale by the patient
Time Frame
1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
Title
Shortness of breath
Description
Severity of the shortness of breath assessed on a visual analogue scale by the patient
Time Frame
1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Pavlov, M.D
Phone
514-362-1000
Ext
63525
Email
ivan.pavlov.md@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Pavlov, M.D.
Organizational Affiliation
CIUSSS-Centre-Sud-de-l'Île-de-Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
CISSS-de-la-Montérégie-Centre
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4V 2H2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Langlois-Carbonneau, M.D.
Facility Name
CIUSSS de l'Est-de-l'ïle-de-Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimiliano Iseppon, M.D.
Facility Name
Hôpital de Verdun
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4G2A2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs