Asymmetrical High Flow Oxygen Versus Noninvasive Ventilation in Acute Hypercapnic Respiratory Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: asymmetrical high-flow nasal cannula, non-invasive ventilation with standard mask, non-invasive ventilation with a new mask.
- Who it may be relevant to
- Registry conditions: Acute Hypercapnic Respiratory Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
NIV is a life-saving treatment for people with breathing failure and carbon dioxide (CO2) retention. It helps remove this waste gas from the lungs and reduces the effort needed to breathe. However, the standard masks used for NIV can become uncomfortable over time, which may lead patients to stop using them. Stopping treatment can be dangerous and may cause breathing problems to worsen. That's why finding devices that are more comfortable and possibly more effective is very important. This study aims to take a first step in that direction. This is the first study comparing new devices designed to help people with chronic CO2 buildup during breathing flare-ups. Devices tested include a new type of asymmetrical nasal cannula for high-flow oxygen therapy and a new mask called OptiNIV, which has a comfortable design that may help remove more CO2. These devices will be compared to standard NIV masks currently used in hospitals. Outcome of interests include their effects on the effort needed to breathe, on how much CO2 is cleared, and on how comfortable they are.
Interventions
- Device asymmetrical high-flow nasal cannula
high-flow nasal oxygen therapy via asymmetrical nasal prongs - Device non-invasive ventilation with standard mask
non-invasive ventilation with standard oronasal mask, clinically used in the participting site - Device non-invasive ventilation with a new mask
non-invasive ventilation with a new mask design, with under-nose, bridge-free design
Primary outcome measures
- Power of Breathing [Time frame: Minute 10, 20, and 30]
Secondary outcome measures (3)
- Ventilatory Ratio [Time frame: Minute 10, 20, and 30]
- Patient's comfort [Time frame: Minute 10, 20, and 30]
- Patient's subjective shortness of breath [Time frame: Minute 10, 20, and 30]
Eligibility criteria
Inclusion criteria
- Diagnosed with acute hypercapnic respiratory failure
- Admitted to the intensive care unit
- Being treated with either high-flow oxygen treatment or non-invasive ventilation
Exclusion criteria
- Clinical instability - defined as the presence of one of the followings: respiratory rate > 40 breaths/minute, SpO2 < 80%, active broncho-pleural fistula, Glasgow Coma Scale < 8, mean arterial pressure below 60 mmHg despite usage of vasopressors
- Requiring immediate need of endotracheal intubation, according to the judgement of the attending physician
- Contraindications of monitoring with electrical impedance tomography (e.g. pacemaker, chest wall burns wounds limiting electrode placement).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- St. Michael's Hospital — Toronto
Identifiers
NCT: NCT07157098 · 25-035