Hypercapnic Respiratory FailureNCT05497986
Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure
A study testing High flow nasal cannula and Conventional low flow oxygenation in people with Hypercapnic Respiratory Failure and Acute Copd Exacerbation, run by Hôpital de Verdun at 3 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure, Acute Copd Exacerbation
- What is being tested?
- High flow nasal cannula and Conventional low flow oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > 18 years of age
- Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 45 mmHg
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
3 sites in 1 country.
Canada3 sites
CISSS-de-la-Montérégie-Centre
Longueuil, Quebec, J4V 2H2
Valérie Langlois-Carbonneau, M.D.
CIUSSS de l'Est-de-l'ïle-de-Montréal
Montreal, Quebec, H1T 2M4
Massimiliano Iseppon, M.D.
Hôpital de Verdun
Montreal, Quebec, H4G2A2
About this study
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.
- Being tested
- High flow nasal cannula, Conventional low flow oxygenation
- Keywords
- High Flow Nasal Cannula, High Flow Nasal Insufflation, High Flow Oxygen Therapy, High Flow Oxygenation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannulaDevice
Also called High flow oxygenation, High flow oxygen therapy
HFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%.
Conventional low flow oxygenationDevice
Conventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Not described Receives: Device: High flow nasal cannula |
| Conventional Oxygenation with low flow cannula | Active comparator | Not described Receives: Device: Conventional low flow oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients progressing to NIV in each cohort
Measured: 6 hours
Secondary outcomes (12)
Venous blood gas PCO2
Measured: 1 hour, 6 hours, and 24 hours
Venous blood gas pH
Measured: 1 hour, 6 hours, and 24 hours
Respiratory rate
Number of breaths per minute, as documented in the medical chart
Measured: 1 hour, 6 hours, 24 hours, and daily until study completion
Heart rate
Number of heart beats per minute, as documented in the medical chart
Measured: 1 hour, 6 hours, 24 hours, and daily until study completion
Mean arterial pressure
Mean arterial pressure, as documented in the medical chart
Measured: 1 hour, 6 hours, 24 hours, and daily until study completion
Incidence of intubation
Measured: Up to 90 days after enrolment, or until hospital discharge
Admission to the intensive care unit
Measured: Up to 90 days after enrolment, or until hospital discharge
In-hospital mortality
Measured: Up to 90 days after enrolment, or until hospital discharge
Intensive care unit length of stay
Measured: Up to 90 days after enrolment, or until discharge from the intensive care unit
Hospital length of stay
Measured: Up to 90 days after enrolment, or until hospital discharge
Patient comfort
Level of comfort assessed on a visual analogue scale by the patient
Measured: 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
Shortness of breath
Severity of the shortness of breath assessed on a visual analogue scale by the patient
Measured: 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital de Verdun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Pavlov, M.D., Principal investigator, CIUSSS-Centre-Sud-de-l'Île-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497986
- Sponsor's protocol ID
- Verdun2022_01
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT05497986
- Acronym / sponsor ID
- Verdun2022_01
- Keywords
- High Flow Nasal Cannula, High Flow Nasal Insufflation, High Flow Oxygen Therapy, High Flow Oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hôpital de VerdunUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Device: High flow nasal cannula |
| Conventional Oxygenation with low flow cannula | Active comparator | Device: Conventional low flow oxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients > 18 years of age
- Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 45 mmHg
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannulaAlso: High flow oxygenation, High flow oxygen therapyHFNC with the maximum tolerated flow (up to 60 L/min). Titration of supplemental oxygen to a SpO2 between 88 - 92%. | Device | High Flow Nasal Cannula |
| Conventional low flow oxygenationConventional oxygenation through nasal prongs or a facemask, with supplemental oxygen titrated to a SpO2 between 88 - 92%. | Device | Conventional Oxygenation with low flow cannula |
Primary outcome
Proportion of patients progressing to NIV in each cohort
Time frame: 6 hours
12 secondary outcomes
Venous blood gas PCO2
Time frame: 1 hour, 6 hours, and 24 hours
Venous blood gas pH
Time frame: 1 hour, 6 hours, and 24 hours
Respiratory rate
Time frame: 1 hour, 6 hours, 24 hours, and daily until study completion
Heart rate
Time frame: 1 hour, 6 hours, 24 hours, and daily until study completion
Mean arterial pressure
Time frame: 1 hour, 6 hours, 24 hours, and daily until study completion
Incidence of intubation
Time frame: Up to 90 days after enrolment, or until hospital discharge
Admission to the intensive care unit
Time frame: Up to 90 days after enrolment, or until hospital discharge
In-hospital mortality
Time frame: Up to 90 days after enrolment, or until hospital discharge
Intensive care unit length of stay
Time frame: Up to 90 days after enrolment, or until discharge from the intensive care unit
Hospital length of stay
Time frame: Up to 90 days after enrolment, or until hospital discharge
Patient comfort
Time frame: 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
Shortness of breath
Time frame: 1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Pavlov, M.D. principal investigator
CIUSSS-Centre-Sud-de-l'Île-de-Montréal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula and Conventional low flow oxygenation in people with Hypercapnic Respiratory Failure and Acute Copd Exacerbation, run by Hôpital de Verdun at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Pavlov, M.D (514-362-1000 ext. 63525, ivan.pavlov.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients progressing to NIV in each cohort (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.