Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

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

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2026-10-01

Brief Summary

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The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure

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Detailed Description

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Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Facemask 'Nivairo'

Oronasal mask for noninvasive ventilation

Group Type ACTIVE_COMPARATOR

Noninvasive ventilation

Intervention Type DEVICE

Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.

Bridge-free facemask 'Visairo'

Bridge-free facemask for noninvasive ventilation. This Bridge-Free NIV contacts the patient's nose only on the nostrils

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type DEVICE

Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.

Facemask 'Optiniv'

Facemask for noninvasive ventilation favoring carbon dioxide washout

Group Type EXPERIMENTAL

Noninvasive ventilation

Intervention Type DEVICE

Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.

Interventions

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Noninvasive ventilation

Respiratory support with a facemask connected to a ventilator through a heated humidifier. Ventilator will be set in the pressure support mode.

Intervention Type DEVICE

Other Intervention Names

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Positive-pressure ventilation

Eligibility Criteria

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Inclusion Criteria

Acute respiratory failure with

* PaCO2 ≥ 45 mmHg;
* Arterial pH \< 7.35;
* Signed written informed consent

Exclusion Criteria

* Respiratory rate \< 12 bpm;
* Immediate need for intubation;
* Haemodynamic instability (Systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) and/or lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed shock;
* Metabolic Acidosis;
* Recent head surgery or anatomy that prevent the application of facemasks;
* Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
* Any contraindications to facemask noninvasive ventilation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No