Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas (NHFDuet)

November 30, 2023 updated by: Georg Nilius, Prof. Dr. med, Kliniken Essen-Mitte

Nasal High Flow (NHF) in COPD - Effects on Ventilation With Asymmetrical Nasal Cannulas (NHFDuet)

The aim of this controlled randomized crossover study is to compare the physiological effects of nasal high flow therapy (NHF) with 2 different nasal cannulas in patients with exacerbated chronic obstructive pulmonary disease (ECOPD) and chronic respiratory failure.

20 patients will be treated with NHF therapy (Airvo, Fisher&Paykel Healthcare, NZ) during wakefulness. Physiological measuremends will take place over three perdiods (visits). One period without NHF, one with NHF via standard cannula (Optiflow M) and one with asymmetrical cannula (Optiflow Duet) in randomised order.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Nasal High Flow (NHF) therapy had shown to increase airway pressure, reduce dead space, and improve mucociliary clearance and gas exchange in patients suffering from chronic obstructive pulmonary disease (COPD). The long-term and short-term physiological aspects of NHF are subject of ongoing research. Different flow rates and cannula sizes have been studied and found to yield different therapeutic effects. Larger sized cannulas tend to seal the nares and produce increased positive airway pressure, while smaller cannulas increase the washout effect. Currently, a new cannula is available, with one smaller and one larger opening (Optiflow+ Duet, Fisher&Paykel Healthcare, NZ).

Procedure: Following a baseline period without high flow therapy, NHF (35L/min) will be applied via the nasal cannula (Duet or Standard in randomized order). After a wash out phase, the NHF interface will be replaced for another measurement with the respective other cannula (Standard or Duet).

Respiratory rate, tidal volume, minute ventilation, inhalation to exhalation ratio (Ti/Te), transcutaneous pCO2 and intercostal EMG will be recorded during each partial measurement.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inpatients with COPD GOLD 3 and 4 in stable phase after acute exacerbation
  • Inpatients with COPD GOLD (2, 3 and 4)
  • Informed Consent

Exclusion Criteria:

  • Acute respiratory insuffiency with respiratory acidosis (pH<7.35)
  • Severe acute physical disease, that do not allow the subject to participate in a clinical trial
  • Language, cognitive, or other barriers that make study participation impossible
  • Pregnancy or Nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nasal High Flow with Optiflow M cannula
Nasal high flow treatment 35L/min with the standard symmetric nasal cannula (Optiflow M)
Device: AIRVO 2
Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.
Other Names:
  • Nasal High Flow
Active Comparator: Nasal High Flow with Optiflow Duet Cannula
Nasal high flow treatment 35L/min with the asymmetric nasal cannula (Optiflow Duet)
Device: AIRVO 2
Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.
Other Names:
  • Nasal High Flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in minute ventilation (MV) comparing arm 1 and 2
Time Frame: 1.5 hours
Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), MV is calculated. Unit is L
1.5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in respiratory rate (RR) comparing arm 1 and 2
Time Frame: 1.5 hours
Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), RR is calculated. Unit is breath per minute
1.5 hours
Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2
Time Frame: 1.5 hours
Respiratory effort is measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), (Ti/Te) is calculated.
1.5 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change oin intercostal surface EMG (surfEMG) comparing arm 1 and 2
Time Frame: 1.5 hours
SurfEMG is measured with EMG system (ADInstruments, NZ), it represents the neural respiratory drive, max ampltude of EMG, unit is mV
1.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kliniken Essen-Mitte

Collaborators

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHFDuet 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on AIRVO 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe