Respiratory FailureHDWOBPTNCT02494154
Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.
A study testing Airvo 2; Ficher and Paykel HealthCare and Oxygen delivery via conventional nasal mask in people with Respiratory Failure, run by Laval University at 1 site in Canada.
Trial summary
This study evaluates the work of breathing among patients under various conditions of treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with respiratory failure (hypercapnic or hypoxemic) will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Airvo 2; Ficher and Paykel HealthCare and Oxygen delivery via conventional nasal mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Oct 2015
- 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
- Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with
- either hypoxemia (SpO2<90% with O2≥3L/min) ;
- or hypercapnia (PaCO2>45 mmHg with a respiratory acidosis (pH<7,38).
Who cannot join
- Patients below 18yo, pregnant or breastfeeding women;
- Patients enrolled in another study excluding co-enrolment;
- History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
- Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax);
- Need for immediate intubation or for continuous noninvasive ventilation and/or recent (<6h) arterial blood gases showing a respiratory acidosis with a pH<7.30;
- Patient feeling nauseous or under recent fed condition (<1h).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IUCPQ
Québec, Quebec, G1V4G5
François Lellouche, MD, PhD, 418-656-8711 ext. 3298, francois.lellouche@criucpq.ulaval.ca
About this study
This study evaluates the work of breathing among patients under various conditions of treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is a cross over of four treatment periods with different flow settings.
Read the detailed description
High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in PaCO2. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.
The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing.
The investigators will evaluate the baseline status with conventional oxygen therapy methods (low flows), and then compare it with three different levels of high flow oxygen therapy in a randomised order. The primary endpoint will be the work of breathing.
- Conditions
- Respiratory Failure
- Being tested
- Airvo 2; Ficher and Paykel HealthCare, Oxygen delivery via conventional nasal mask
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airvo 2; Ficher and Paykel HealthCareDevice
High flow nasal cannulas
Oxygen delivery via conventional nasal maskDevice
Low flow of oxygen delivered through conventional nasal prongs
| Study group | Role | What they receive |
|---|---|---|
| Conventional flow via nasal prongs | Active comparator | Oxygen delivery via conventional nasal interface with flow adjusted to reach a target SpO2 according to the patient's condition. Receives: Device: Oxygen delivery via conventional nasal mask |
| High flow nasal cannulas 20L/min | Experimental | Oxygen delivery via high flow nasal cannulas (20L/min) with fraction of inspired oxygen (FiO2) adjusted to reach a target SpO2 according to the patient's condition. Receives: Device: Airvo 2; Ficher and Paykel HealthCare |
| High flow nasal cannulas 40L/min | Experimental | Oxygen delivery via high flow nasal cannulas (40L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition. Receives: Device: Airvo 2; Ficher and Paykel HealthCare |
| High flow nasal cannulas 60L/min | Experimental | Oxygen delivery via high flow nasal cannulas (60L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition. Receives: Device: Airvo 2; Ficher and Paykel HealthCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work of breathing
Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome)
Measured: 15 minutes
Secondary outcomes (9)
Esophageal pressure-time product
Measured at the end of each period
Measured: 15 minutes
Tidal volume
Measured at the end of each period
Measured: 15 minutes
Comfort of breathing
Subjective evaluation at the end of each period
Measured: 15 minutes
Blood gases
Arterial or capillary blood gases at the end of each period
Measured: 15 minutes
Dyspnea
Evaluation on a borg scale at the end of each period
Measured: 15 minutes
Respiratory rate
Measured at the end of each period
Measured: 15 minutes
Heart rate
Measured at the end of each period
Measured: 15 minutes
End-tidal carbon dioxide
Measured at the end of each period
Measured: 15 minutes
Oxygen saturation
Measured at the end of each period
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015 (estimated)
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.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Lellouche, MD, PhD, Study director, Fondation IUCPQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494154
- Sponsor's protocol ID
- IUCPQ-HDWOBPT
- Acronym
- HDWOBPT
- Status last verified
- Jul 2015
- First submitted
- 4 Jun 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.
- ClinicalTrials.gov ID
- NCT02494154
- Acronym / sponsor ID
- HDWOBPT / IUCPQ-HDWOBPT
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2015 (estimated)
- First posted
- 10 Jul 2015 (estimated)
- 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.
This study evaluates the work of breathing among patients under various conditions of treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is a cross over of four treatment periods with different flow settings.
Detailed description
High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in PaCO2. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.
The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing.
The investigators will evaluate the baseline status with conventional oxygen therapy methods (low flows), and then compare it with three different levels of high flow oxygen therapy in a randomised order. The primary endpoint will be the work of breathing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional flow via nasal prongs | Active comparator | Device: Oxygen delivery via conventional nasal maskOxygen delivery via conventional nasal interface with flow adjusted to reach a target SpO2 according to the patient's condition. |
| High flow nasal cannulas 20L/min | Experimental | Device: Airvo 2; Ficher and Paykel HealthCareOxygen delivery via high flow nasal cannulas (20L/min) with fraction of inspired oxygen (FiO2) adjusted to reach a target SpO2 according to the patient's condition. |
| High flow nasal cannulas 40L/min | Experimental | Device: Airvo 2; Ficher and Paykel HealthCareOxygen delivery via high flow nasal cannulas (40L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition. |
| High flow nasal cannulas 60L/min | Experimental | Device: Airvo 2; Ficher and Paykel HealthCareOxygen delivery via high flow nasal cannulas (60L/min) with FiO2 adjusted to reach a target SpO2 according to the patient's condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with
- either hypoxemia (SpO2<90% with O2≥3L/min) ;
- or hypercapnia (PaCO2>45 mmHg with a respiratory acidosis (pH<7,38).
Key exclusion criteria (6 listed)
- Patients below 18yo, pregnant or breastfeeding women;
- Patients enrolled in another study excluding co-enrolment;
- History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
- Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax);
- Need for immediate intubation or for continuous noninvasive ventilation and/or recent (<6h) arterial blood gases showing a respiratory acidosis with a pH<7.30;
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 |
|---|---|---|
| Airvo 2; Ficher and Paykel HealthCareHigh flow nasal cannulas | Device | High flow nasal cannulas 20L/min, High flow nasal cannulas 40L/min, High flow nasal cannulas 60L/min |
| Oxygen delivery via conventional nasal maskLow flow of oxygen delivered through conventional nasal prongs | Device | Conventional flow via nasal prongs |
Primary outcome
Work of breathing
Time frame: 15 minutes
Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome)
9 secondary outcomes
Esophageal pressure-time product
Time frame: 15 minutes
Tidal volume
Time frame: 15 minutes
Comfort of breathing
Time frame: 15 minutes
Blood gases
Time frame: 15 minutes
Dyspnea
Time frame: 15 minutes
Respiratory rate
Time frame: 15 minutes
Heart rate
Time frame: 15 minutes
End-tidal carbon dioxide
Time frame: 15 minutes
Oxygen saturation
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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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.
François Lellouche, MD, PhD study director
Fondation IUCPQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airvo 2; Ficher and Paykel HealthCare and Oxygen delivery via conventional nasal mask in people with Respiratory Failure, run by Laval University 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 3 inclusion and 6 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 10 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Delorme, PT, MSc (418-656-8711 ext. 3508, mathieu.delorme.2@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work of breathing (time frame: 15 minutes). 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 10 Jul 2015.