Acute Hypercapnic Respiratory Failure
Conditions
Keywords
acute hypercapnic respiratory failure, non-invasive ventilation, high-flow oxygen
Brief summary
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
DEVICEasymmetrical high-flow nasal cannula
high-flow nasal oxygen therapy via asymmetrical nasal prongs
DEVICEnon-invasive ventilation with standard mask
non-invasive ventilation with standard oronasal mask, clinically used in the participting site
DEVICEnon-invasive ventilation with a new mask
non-invasive ventilation with a new mask design, with under-nose, bridge-free design
Sponsors
Unity Health Toronto
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will go through three intervention steps, each with a different breathing support: asymmetrical high-flow nasal cannula (HFNC), non-invasive ventilation (NIV) using the standard NIV mask at the participating center, and NIV using a new mask design. Each step lasts 10 minutes.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Power of Breathing | Minute 10, 20, and 30 | A marker of the patient's work of breathing. Calculated by thickening fraction of the diaphragm, multiplied by the respiratory rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilatory Ratio | Minute 10, 20, and 30 | A marker of ventilation efficiency. Calculated from carbon dioxide level (in this case, obtained from transcutaneous capnography) and minute ventilation (in this case, obtained from electrical impedance tomography) |
| Patient's comfort | Minute 10, 20, and 30 | Obtained from a visual analog scale from 1 to 10, with 10 indicating the highest comfort |
| Patient's subjective shortness of breath | Minute 10, 20, and 30 | Obtained from a visual analog scale from 1 to 10, with 10 indicating the worst shortness of breath |
Countries
Canada
Contacts
Primary ContactNattapat Wongtirawit, M.D.
Outcome results
None listed