Acute Hypercapnic Respiratory FailureNCT06007495
Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
A study testing Investigational full-face mask with expiratory washout, Conventional full-face mask - single-limb and Conventional full-face mask - dual-limb in people with Acute Hypercapnic Respiratory Failure and Acute Hypoxemic Respiratory Failure, run by Fisher and Paykel Healthcare at 2 sites in Canada.
Trial summary
The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
- What is being tested?
- Investigational full-face mask with expiratory washout, Conventional full-face mask - single-limb and Conventional full-face mask - dual-limb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 6 May 2024to Dec 2025
- 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
- No indication of intubation upon evaluation by physician in the next 2 hours
- Fits the investigational mask
- Specific for hypercapnic patients 1 of the following criteria
- Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or;
- Patient admitted to hospital with ARF with one criteria for NIV among the following:
- Acute hypercapnic respiratory failure with hypercapnia and acidosis (Partial pressure of arterial carbon dioxide (PaCO2) > 45 millimeters of mercury (mmHg) and pH < 7.38) or
Show all 12Show fewer
- Post-extubation period within 48 hours, in patients with high risk of re-intubation
- Specific for hypoxemic patients
- 1 of the following criteria
- Hypoxemic respiratory failure without hypercapnia requiring nasal high flow or;
- Hypoxemic respiratory failure without hypercapnia requiring NIV or;
- Conventional oxygen therapy (COT) > 6 liters per minute (L/min) with peripheral oxygen saturation (SpO2) < 92%
Who cannot join
- Refusal to participate in the study
- Inability to provide informed consent
- Infectious isolation
- Facial deformity, burns or morphology that prevents adequate mask placement
- Claustrophobia
- Nausea
Show all 11Show fewer
- Presence of nasogastric tube
- Pneumothorax
- Confusion or loss of consciousness
- Severe upper gastro-intestinal bleeding
- Any other condition, which at the investigators discretion, is believed may present a safety risk or impact the feasibility of the study or study results
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Centre hospitalier de l&#39;Université de Montréal (CHUM)
Montreal, Quebec, 20094
Dr. Charbonney, 514 890-8000, emmanuel.charbonney@umontreal.ca
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, 2712
Dr. Lellouche, 418-656-8711, francois.lellouche@criucpq.ulaval.ca
About this study
The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main questions it aims to answer are:
- Does a mask with expiratory washout improve minute ventilation in patients using non-invasive ventilation compared with a conventional single-limb NIV mask
- How does a mask with expiratory washout affect respiratory variables compared with a dual-limb NIV mask.
Read more
Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized order:
- Single-limb NIV with investigation mask (with expiratory washout)
- Single-limb NIV with conventional mask
- Dual-limb NIV with conventional mask
Read the detailed description
The investigational mask has been designed to deliver non-invasive ventilation (NIV) therapy with expiratory washout.
Expiratory washout is a technique designed to flush the upper airway of carbon dioxide at the end of expiration. During conventional NIV the gas at end of exhalation contributes to the functional dead space and "wasted" ventilation. The primary purpose of expiratory washout is to flush the upper airway with fresh gas during exhalation so the next supported breath which drives gas back into the alveolar regions has reduced carbon dioxide.
Patients that are admitted to hospital with acute (hypercapnic or hypoxemic) respiratory failure, as assessed by normal hospital protocols, and starting or prescribed to start NIV therapy will be considered for the investigation. Once stabilized on NIV by the physician in charge of their care, eligible patients will be assessed against the inclusion/exclusion criteria and enrolled into the study if applicable.
Participants that are enrolled into the study will be put onto oxygen therapy via nasal cannula for 15 minutes, during which time baseline measurements of physiological parameters (such as respiratory rate, tidal volume, minute ventilation and blood gases) and dyspnea scores will be recorded.
Following baseline measurements, 32 participants will be randomized into one of the 3 investigational arms and receive NIV with heated humidification according to the randomization protocol for 30 minutes each arm (90 minutes total). The same measurements will be recorded at the end of each 30-minute investigational arm. Participants will cross over to the other 2 conditions consecutively in a random order, each for 30 minutes.
The ventilator settings (press support ventilation (PSV), positive end expiratory pressure (PEEP)) will be the following: PSV for tidal volume comprised between 6 and 8 millilitres per kilogram (ml/kg) predicted body weight (PBW), a titration period will be planned at the beginning of the first study period to target a tidal volume of 7 +/-1 ml/kg PBW and the PSV level will be kept constant thereafter. PEEP will be set according to the physician in charge (between 5 and 10 centimetres of water (cmH2O)) if NIV was used before inclusion or will be set by the investigators between 5 and 10 cmH2O. The fraction of inspired oxygen will be titrated manually to target peripheral saturation of oxygen of 88-92% in patients with hypercapnia and 90-94% in patients without hypercapnia.
Once the investigation is complete, and participants have successfully finished all 3 arms of NIV therapy, the standard NIV protocols as per local hospital will resume, and participants will return to the care of their usual physician.
- Being tested
- Investigational full-face mask with expiratory washout, Conventional full-face mask - single-limb, Conventional full-face mask - dual-limb
- Keywords
- Non-invasive Ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational full-face mask with expiratory washoutDevice
With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation
Conventional full-face mask - single-limbDevice
Also called RT077
With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation
Conventional full-face mask - dual-limbDevice
Also called RT076
With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| Single-limb non-invasive ventilation with expiratory washout | Experimental | In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout Receives: Device: Investigational full-face mask with expiratory washout |
| Single-limb non-invasive ventilation | Active comparator | In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent) Receives: Device: Conventional full-face mask - single-limb |
| Dual-limb non-invasive ventilation | Active comparator | In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent) Receives: Device: Conventional full-face mask - dual-limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute Ventilation
Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)
Measured: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Secondary outcomes (5)
Tidal Volume
Changes in tidal volume over the three different arms
Measured: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Respiratory Rate
Changes in respiratory rate over the three different arms
Measured: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Blood gases
Changes in blood gas values over the three different arms
Measured: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Dyspnoea Score
Changes in dyspnea score over the three different arms. Dyspnea measured with the modified Borg dyspnea score, which utilizes a scale of 0 to 10 where 0 represents no dyspnea and 10 represents maximal dyspnea.
Measured: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Mask Comfort Score
Changes in mask comfort score over the three different arms. Mask comfort will be measured with a subjective likert scale of comfort where 1 represents maximal comfort, and 5 represents least comfort.
Measured: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start6 May 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe 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
- Model description
- Randomized Cross-Over study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre hospitalier de l'Université de Montréal (CHUM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007495
- Sponsor's protocol ID
- CIP_336
- Status last verified
- Sep 2024
- First submitted
- 14 Aug 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
- ClinicalTrials.gov ID
- NCT06007495
- Acronym / sponsor ID
- CIP_336
- Keywords
- Non-invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 6 May 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Aug 2023 (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.
The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main questions it aims to answer are:
- Does a mask with expiratory washout improve minute ventilation in patients using non-invasive ventilation compared with a conventional single-limb NIV mask
- How does a mask with expiratory washout affect respiratory variables compared with a dual-limb NIV mask.
Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized order:
- Single-limb NIV with investigation mask (with expiratory washout)
- Single-limb NIV with conventional mask
- Dual-limb NIV with conventional mask
Detailed description
The investigational mask has been designed to deliver non-invasive ventilation (NIV) therapy with expiratory washout.
Expiratory washout is a technique designed to flush the upper airway of carbon dioxide at the end of expiration. During conventional NIV the gas at end of exhalation contributes to the functional dead space and "wasted" ventilation. The primary purpose of expiratory washout is to flush the upper airway with fresh gas during exhalation so the next supported breath which drives gas back into the alveolar regions has reduced carbon dioxide.
Patients that are admitted to hospital with acute (hypercapnic or hypoxemic) respiratory failure, as assessed by normal hospital protocols, and starting or prescribed to start NIV therapy will be considered for the investigation. Once stabilized on NIV by the physician in charge of their care, eligible patients will be assessed against the inclusion/exclusion criteria and enrolled into the study if applicable.
Participants that are enrolled into the study will be put onto oxygen therapy via nasal cannula for 15 minutes, during which time baseline measurements of physiological parameters (such as respiratory rate, tidal volume, minute ventilation and blood gases) and dyspnea scores will be recorded.
Following baseline measurements, 32 participants will be randomized into one of the 3 investigational arms and receive NIV with heated humidification according to the randomization protocol for 30 minutes each arm (90 minutes total). The same measurements will be recorded at the end of each 30-minute investigational arm. Participants will cross over to the other 2 conditions consecutively in a random order, each for 30 minutes.
The ventilator settings (press support ventilation (PSV), positive end expiratory pressure (PEEP)) will be the following: PSV for tidal volume comprised between 6 and 8 millilitres per kilogram (ml/kg) predicted body weight (PBW), a titration period will be planned at the beginning of the first study period to target a tidal volume of 7 +/-1 ml/kg PBW and the PSV level will be kept constant thereafter. PEEP will be set according to the physician in charge (between 5 and 10 centimetres of water (cmH2O)) if NIV was used before inclusion or will be set by the investigators between 5 and 10 cmH2O. The fraction of inspired oxygen will be titrated manually to target peripheral saturation of oxygen of 88-92% in patients with hypercapnia and 90-94% in patients without hypercapnia.
Once the investigation is complete, and participants have successfully finished all 3 arms of NIV therapy, the standard NIV protocols as per local hospital will resume, and participants will return to the care of their usual physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Cross-Over study
| Arm | Type | Receives |
|---|---|---|
| Single-limb non-invasive ventilation with expiratory washout | Experimental | Device: Investigational full-face mask with expiratory washoutIn a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout |
| Single-limb non-invasive ventilation | Active comparator | Device: Conventional full-face mask - single-limbIn a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent) |
| Dual-limb non-invasive ventilation | Active comparator | Device: Conventional full-face mask - dual-limbIn a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- No indication of intubation upon evaluation by physician in the next 2 hours
- Fits the investigational mask
- Specific for hypercapnic patients 1 of the following criteria
- Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or;
- Patient admitted to hospital with ARF with one criteria for NIV among the following:
Key exclusion criteria (11 listed)
- Refusal to participate in the study
- Inability to provide informed consent
- Infectious isolation
- Facial deformity, burns or morphology that prevents adequate mask placement
- Claustrophobia
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 |
|---|---|---|
| Investigational full-face mask with expiratory washoutWith cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation | Device | Single-limb non-invasive ventilation with expiratory washout |
| Conventional full-face mask - single-limbAlso: RT077With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation | Device | Single-limb non-invasive ventilation |
| Conventional full-face mask - dual-limbAlso: RT076With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation | Device | Dual-limb non-invasive ventilation |
Primary outcome
Minute Ventilation
Time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)
5 secondary outcomes
Tidal Volume
Time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Respiratory Rate
Time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Blood gases
Time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Dyspnoea Score
Time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Mask Comfort Score
Time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational full-face mask with expiratory washout, Conventional full-face mask - single-limb and Conventional full-face mask - dual-limb in people with Acute Hypercapnic Respiratory Failure and Acute Hypoxemic Respiratory Failure, run by Fisher and Paykel Healthcare at 2 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 12 inclusion and 11 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 James Miller (+64273032944, jamie.miller@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minute Ventilation (time frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement). 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 14 Mar 2025.