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Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.

Primary Purpose

Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Investigational full-face mask with expiratory washout
Conventional full-face mask - single-limb
Conventional full-face mask - dual-limb
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure focused on measuring Non-invasive Ventilation

Eligibility Criteria

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

Inclusion Criteria: 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 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% Exclusion Criteria: 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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Single-limb non-invasive ventilation with expiratory washout

    Single-limb non-invasive ventilation

    Dual-limb non-invasive ventilation

    Arm Description

    In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout

    In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent)

    In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent)

    Outcomes

    Primary Outcome Measures

    Minute Ventilation
    Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)

    Secondary Outcome Measures

    Tidal Volume
    Changes in tidal volume over the three different arms
    Respiratory Rate
    Changes in respiratory rate over the three different arms
    Blood gases
    Changes in blood gas values over the three different arms
    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.
    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.

    Full Information

    First Posted
    August 14, 2023
    Last Updated
    August 21, 2023
    Sponsor
    Fisher and Paykel Healthcare
    Collaborators
    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre hospitalier de l'Université de Montréal (CHUM)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06007495
    Brief Title
    Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.
    Official Title
    Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fisher and Paykel Healthcare
    Collaborators
    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre hospitalier de l'Université de Montréal (CHUM)

    4. Oversight

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

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
    Keywords
    Non-invasive Ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Randomized Cross-Over study
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-limb non-invasive ventilation with expiratory washout
    Arm Type
    Experimental
    Arm Description
    In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout
    Arm Title
    Single-limb non-invasive ventilation
    Arm Type
    Active Comparator
    Arm Description
    In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent)
    Arm Title
    Dual-limb non-invasive ventilation
    Arm Type
    Active Comparator
    Arm Description
    In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent)
    Intervention Type
    Device
    Intervention Name(s)
    Investigational full-face mask with expiratory washout
    Intervention Description
    With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation
    Intervention Type
    Device
    Intervention Name(s)
    Conventional full-face mask - single-limb
    Other Intervention Name(s)
    RT077
    Intervention Description
    With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation
    Intervention Type
    Device
    Intervention Name(s)
    Conventional full-face mask - dual-limb
    Other Intervention Name(s)
    RT076
    Intervention Description
    With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation
    Primary Outcome Measure Information:
    Title
    Minute Ventilation
    Description
    Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)
    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
    Secondary Outcome Measure Information:
    Title
    Tidal Volume
    Description
    Changes in tidal volume over the three different arms
    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
    Title
    Respiratory Rate
    Description
    Changes in respiratory rate over the three different arms
    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
    Title
    Blood gases
    Description
    Changes in blood gas values over the three different arms
    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
    Title
    Dyspnoea Score
    Description
    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.
    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
    Title
    Mask Comfort Score
    Description
    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.
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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% Exclusion Criteria: 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 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

    12. IPD Sharing Statement

    Learn more about this trial

    Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.

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