Effects on Ventilation With NHF and Asymmetrical Nasal Cannulas

NCT05676502 | Unknown

• 1 other identifier: NHFDuet 2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Nasal High Flow (NHF); High Flow Nasal Cannula (HFNC); Optiflow; COPD

Outcome Measures

Primary Outcomes (1)

• Change in minute ventilation (MV) comparing arm 1 and 2

  Respiratory effort measured with calibrated RIP system (Respitrace QDC; Viasys Services, Lakeland, FL), MV is calculated. Unit is L

  1.5 hours

Secondary Outcomes (2)

• Change in respiratory rate (RR) comparing arm 1 and 2

  1.5 hours

• Change in inhalation to exhalation ratio (Ti/Te) comparing arm 1 and 2

  1.5 hours

Other Outcomes (1)

• Change oin intercostal surface EMG (surfEMG) comparing arm 1 and 2

  1.5 hours

Study Arms (2)

Nasal High Flow with Optiflow M cannula

ACTIVE COMPARATOR

Nasal high flow treatment 35L/min with the standard symmetric nasal cannula (Optiflow M)

Device: AIRVO 2

Nasal High Flow with Optiflow Duet Cannula

ACTIVE COMPARATOR

Nasal high flow treatment 35L/min with the asymmetric nasal cannula (Optiflow Duet)

Device: AIRVO 2

Interventions

AIRVO 2 DEVICE

Patients with chronic obstructive pulmonary disease and chronic respiratory failure use Nasal High Flow therapy during daytime sessions of 1.5 h.

Also known as: Nasal High Flow

Nasal High Flow with Optiflow Duet Cannula; Nasal High Flow with Optiflow M cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Georg N Nilius

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Georg N Nilius, Prof. Dr. med

CONTACT

+49 201 174; G.Nilius@kem-med.com

Ulrike Domanski

CONTACT

+49 0201 174; U.Domanski@kem-med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Pneumology, PI

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: January 19, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)