Respiratory FailureNCT03443479
Comparison of High-flow Oxygen vs. BiPAP in Type II (Hypercapnic) Respiratory Failure
An observational study of Respiratory Failure and Respiratory Insufficiency, run by Hôpital de Verdun at 1 site in Canada.
Trial summary
A retrospective cohort study of all patients treated for type II (hypercapnic) respiratory failure with either High-Flow Oxygen Therapy or Non-Invasive Ventilation in a general adult hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Respiratory Insufficiency, Respiratory Tract Diseases
- What is being tested?
- Non-Invasive Ventilation and High-Flow Nasal Cannula
- Type of treatment
- Medical device
- How many people
- 324 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2015to 1 Jul 2019
- Phase
- Observational
- 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
Study population: All patients treated for respiratory II failure in the hospital, including patients treated on the general medical floors, in the emergency department, and in the intensive-care unit.
Who may be able to join
- All patients treated with respiratory failure not responding to conventional supplemental oxygen therapy
- Blood venous gas showing partial pressure of carbon dioxide>50 mmHg before beginning therapy with either NIV or HFNC
Who cannot join
- Lack of records of the primary outcome
- End-of-life care
- Lack of gas before the beginning of NIV or HFNC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Cohort Study of Patients With Type II (Hypercapnic) Respiratory Failure Treated With High-flow Oxygen Therapy Versus Non-invasive Ventilation With BiPAP
A retrospective cohort study of all patients treated for type II (hypercapnic) respiratory failure with either High-Flow Oxygen Therapy or Non-Invasive Ventilation in a general adult hospital.
Read the detailed description
We will compare various clinically relevant outcomes in patients treated for type II (hypercapnic) acute respiratory failure (ARF) with either High-Flow Nasal Cannula (HFNC) or Non-Invasive Ventilation (NIV) in a general adult hospital.
All patients treated with HFNC were treated with an Optiflow device (Fisher\&Paykel). Various Bilevel positive airway pressure (BiPAP) devices were used during the study period.
All ventilatory parameters were set according to the treating physicians' preferences.
- Conditions
- Respiratory Failure, Respiratory Insufficiency, Respiratory Tract Diseases, COPD, COPD Exacerbation, Pneumonia
- Being tested
- Non-Invasive Ventilation, High-Flow Nasal Cannula
- Keywords
- Non invasive ventilation, BiPAP, High-Flow Oxygen Therapy, High-Flow Nasal Cannula, COPD, Hypercapnia, Hypercapnic Respiratory failure, Chronic obstructive Pulmonary Disease
- Medical subject headings
- Respiratory Insufficiency, Respiratory Tract Diseases, Pulmonary Disease, Chronic Obstructive, Pneumonia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive VentilationDevice
Also called BiPAP
Treatment with Non-Invasive Ventilation by BiPAP. Different BiPAP models are in use. Ventilation parameters set at the discretion of the treating physician.
High-Flow Nasal CannulaDevice
Also called HFNC
Treatment with a High-Flow Nasal Cannula. The Optiflow device by Fisher\&Paykel used in all cases. Flow and fraction of inspired oxygen (FiO2) parameters at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type II ARF | All patients with type II respiratory failure that were deemed by the treating physician to require ventilatory support either with non-invasive ventilation (NIV) or High-Flow Nasal Cannula (HFNC). Receives: Device: Non-Invasive Ventilation; Device: High-Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of initial treatment (combined outcome)
Combined outcome of death or intubation or transition to another treatment modality or unplanned resumption of respiratory support
Measured: 48 hours post intervention
Death at 48h
Mortality in the 48h following the initial intervention
Measured: 48 hours post intervention
Secondary outcomes (5)
Mortality at 7d
Incidence of death in the 7 days after intervention
Measured: 7 days post intervention
Incidence of endotracheal intubation
The incidence of intubation
Measured: For the whole length of hospital stay, up to a maximum of one year.
Length of stay
Duration of stay in the hospital, in days
Measured: For the whole length of hospital stay, up to a maximum of one year.
Duration of endotracheal intubation
Duration (in hours) of the first episode of endotracheal intubation, immediately following the failed intervention
Measured: For the whole length of hospital stay, up to a maximum of one year.
Incidence of intervention change
The incidence of patients who switch from Non-Invasive Ventilation to High-Flow Oxygen, and vice versa, due to treatment failure
Measured: For the whole length of hospital stay, up to a maximum of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Apr 2015
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital de Verdun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Pavlov, MD, Principal investigator, Ivan Pavlov MD CP inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443479
- Sponsor's protocol ID
- OF1
- Status last verified
- Jul 2020
- First submitted
- 15 Feb 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study of Patients With Type II (Hypercapnic) Respiratory Failure Treated With High-flow Oxygen Therapy Versus Non-invasive Ventilation With BiPAP
- ClinicalTrials.gov ID
- NCT03443479
- Acronym / sponsor ID
- OF1
- Conditions
- Respiratory Failure, Respiratory Insufficiency, Respiratory Tract Diseases, COPD, COPD Exacerbation, Pneumonia
- Keywords
- Non invasive ventilation, BiPAP, High-Flow Oxygen Therapy, High-Flow Nasal Cannula, COPD, Hypercapnia, Hypercapnic Respiratory failure, Chronic obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Hôpital de VerdunUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 23 Feb 2018 (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.
A retrospective cohort study of all patients treated for type II (hypercapnic) respiratory failure with either High-Flow Oxygen Therapy or Non-Invasive Ventilation in a general adult hospital.
Detailed description
We will compare various clinically relevant outcomes in patients treated for type II (hypercapnic) acute respiratory failure (ARF) with either High-Flow Nasal Cannula (HFNC) or Non-Invasive Ventilation (NIV) in a general adult hospital.
All patients treated with HFNC were treated with an Optiflow device (Fisher\&Paykel). Various Bilevel positive airway pressure (BiPAP) devices were used during the study period.
All ventilatory parameters were set according to the treating physicians' preferences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with type II ARF | – | Device: Non-Invasive Ventilation, Device: High-Flow Nasal CannulaAll patients with type II respiratory failure that were deemed by the treating physician to require ventilatory support either with non-invasive ventilation (NIV) or High-Flow Nasal Cannula (HFNC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated for respiratory II failure in the hospital, including patients treated on the general medical floors, in the emergency department, and in the intensive-care unit.
Key inclusion criteria (2 listed)
- All patients treated with respiratory failure not responding to conventional supplemental oxygen therapy
- Blood venous gas showing partial pressure of carbon dioxide>50 mmHg before beginning therapy with either NIV or HFNC
Key exclusion criteria (3 listed)
- Lack of records of the primary outcome
- End-of-life care
- Lack of gas before the beginning of NIV or HFNC
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 |
|---|---|---|
| Non-Invasive VentilationAlso: BiPAPTreatment with Non-Invasive Ventilation by BiPAP. Different BiPAP models are in use. Ventilation parameters set at the discretion of the treating physician. | Device | Patients with type II ARF |
| High-Flow Nasal CannulaAlso: HFNCTreatment with a High-Flow Nasal Cannula. The Optiflow device by Fisher\&Paykel used in all cases. Flow and fraction of inspired oxygen (FiO2) parameters at the discretion of the treating physician. | Device | Patients with type II ARF |
Primary outcome
Failure of initial treatment (combined outcome)
Time frame: 48 hours post intervention
Combined outcome of death or intubation or transition to another treatment modality or unplanned resumption of respiratory support
Death at 48h
Time frame: 48 hours post intervention
Mortality in the 48h following the initial intervention
5 secondary outcomes
Mortality at 7d
Time frame: 7 days post intervention
Incidence of endotracheal intubation
Time frame: For the whole length of hospital stay, up to a maximum of one year.
Length of stay
Time frame: For the whole length of hospital stay, up to a maximum of one year.
Duration of endotracheal intubation
Time frame: For the whole length of hospital stay, up to a maximum of one year.
Incidence of intervention change
Time frame: For the whole length of hospital stay, up to a maximum of one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Ivan Pavlov MD CP inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Respiratory Insufficiency, run by Hôpital de Verdun at 1 site 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 3 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: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of initial treatment (combined outcome) (time frame: 48 hours post intervention). The study lists 2 primary outcomes in all. 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 28 Jul 2020.