Efficacy of NIV Masks in COPD

COPD Clinical Trial

Official title:

Efficacy of NIV Masks in COPD Patients With Chronic Respiratory Failure: A Randomized Controlled Cross Over Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04947852
• Other study ID #: CIA293
• Status: Completed
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: March 17, 2022

Study information

• Verified date: March 2022
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A doctor's diagnosis of COPD

• PtCO2 =45mmHg on transcutaneous monitor at baseline measure

• Oxygen saturation measured by pulse oximetry (SpO2) =85%

• Fits the study mask

• Can tolerate the therapy

Exclusion Criteria:

• FEV1/FVC =70%

• Body mass index >35

• Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea

• Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Investigation Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
• Comparator Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff

Locations

Country	Name	City	State
New Zealand	Medical Research Institute New Zealand	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcutaneous Carbon Dioxide	mmHg	60 minutes
Secondary	Oxygen Saturation	Percentage	60 minutes
Secondary	Minute Ventilation	Litres	60 minutes
Secondary	Heart Rate	Beats per minute	60 minutes
Secondary	Respiratory Rate	Breaths per minute	60 minutes
Secondary	Borg Dyspnoea Score	1-6 Ranking, with 1 being best and 6 being worst	60 Minutes