Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

ConditionsAcute Hypercapnic Respiratory Failure Acute Hypoxemic Respiratory Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorFisher and Paykel Healthcare

About this trial

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.

Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized order:

* Single-limb NIV with investigation mask (with expiratory washout) * Single-limb NIV with conventional mask * Dual-limb NIV with conventional mask

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

No indication of intubation upon evaluation by physician in the next 2 hours

Fits the investigational mask

Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or;

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

Disqualifiers

Refusal to participate in the study

Inability to provide informed consent

Infectious isolation

Facial deformity, burns or morphology that prevents adequate mask placement

Trial design

Design model

Crossover

Treatments tested in this trial

Investigational full-face mask with expiratory washout
Device
With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation
Conventional full-face mask - single-limb
Device
With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation
Conventional full-face mask - dual-limb
Device
With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation

Treatment groups

32 Participants

are divided into 3 treatment groups

Group A: Single-limb non-invasive ventilation with expiratory washoutExperimental treatment 1 intervention

Group B: Single-limb non-invasive ventilationActive comparator 1 intervention

Group C: Dual-limb non-invasive ventilationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Minute Ventilation

Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)

Time frame