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Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure

NCT05964244 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-27

No results posted yet for this study

Summary

This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order;

1. NIV for one hour with the investigational mask (Vela)
2. NIV for one hour with the standard mask (Nivairo).

Participants will have their physiological respiratory parameters recorded.

Conditions

  • Noninvasive Ventilation

Interventions

DEVICE

Vela Investigational Mask

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.

DEVICE

Nivairo Standard Mask

Wear mask to enable the delivery of noninvasive ventilation (CPAP or bilevel) therapy.

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-05-31
Completion
2024-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05964244 on ClinicalTrials.gov