Asymmetrical High Flow Oxygen Versus Noninvasive Ventilation in Acute Hypercapnic Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Hypercapnic Respiratory Failure

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All study patient

Sequential respiratory support with 3 devices

Group Type EXPERIMENTAL

asymmetrical high-flow nasal cannula

Intervention Type DEVICE

high-flow nasal oxygen therapy via asymmetrical nasal prongs

non-invasive ventilation with standard mask

Intervention Type DEVICE

non-invasive ventilation with standard oronasal mask, clinically used in the participting site

non-invasive ventilation with a new mask

Intervention Type DEVICE

non-invasive ventilation with a new mask design, with under-nose, bridge-free design

Interventions

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asymmetrical high-flow nasal cannula

high-flow nasal oxygen therapy via asymmetrical nasal prongs

Intervention Type DEVICE

non-invasive ventilation with standard mask

non-invasive ventilation with standard oronasal mask, clinically used in the participting site

Intervention Type DEVICE

non-invasive ventilation with a new mask

non-invasive ventilation with a new mask design, with under-nose, bridge-free design

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No