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New treatment option for Acute Hypercapnic Respiratory Failure
Official title Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
ClinicalTrials.gov ID: NCT06007495
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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%
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada; Québec, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.