Comparing the effect of Nasal High Flow (NHF) therapy with Non-invasive ventilation (NIV) on carbon dioxide levels in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic respiratory failure

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12616001701415
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.A doctor’s diagnosis of COPD
2. PcapCO2 >45mmHg on Capillary blood gas, at point of randomisation
3.Age greater than or equal to 40 years old.

Exclusion Criteria

1.Smoking pack year history <10 years
2.FEV1/FVC greater than or equal to 70%
3.Body mass index >35
4.Hypercapnea believed to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnoea
5.Any condition which makes NIV contra-indicated as per BTS guidelines.
6.Requiring greater than or equal to 4 L/min through standard nasal cannulae during the wash-in period to maintain oxygen saturations 88-92%.
7.COPD not deemed to be ‘stable’:
a.Current exacerbation requiring acute treatment with a short course of antibiotics/oral steroids within the last 2 weeks.
b.Hospital admission for an acute exacerbation of COPD in the last 6 weeks.
8.Nasal conditions such as deviated septum, chronic rhinitis, current cold/flu which, in the evaluation by the investigator, could impair nasal breathing.
9.Any other condition, which at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or study results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transcutaneous partial pressure of carbon dioxide (PtCO2) at 60 minutes adjusted for baseline. Nb: Baseline is the measurement taken at t=0 at the start of each intervention. Intervention number 2 will have a baseline +/- 4mmHg from baseline for Intervention 1. This will be measured on a Sentec transcutaneous monitor. [60 minutes]