Nasal High Flow (NHF) in COPD - Effects on Ventilation in Wakefulness

NCT05053074 | Completed

• 1 other identifier: NHFwake2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Controlled randomized crossover trial in patients with chronic obstructive respiratory disease (COPD), who are treated with Nasal High Flow (NHF) therapy during wakefulness with a small amount of CO2 added to the inhaled air to keep the patients' PaCO2 stable despite the washout effect. Aim of the study is to examine respiratory rate, tidal volume and work of breathing under NHF without the CO2 washout effect.

Conditions

COPD

Keywords

Nasal High Flow; PaCO2; Tidal Volume; Washout Effect

Outcome Measures

Primary Outcomes (1)

• Minute Ventilation

  Difference in respiratory minute volume under NHF versus NHF/CO2.

  up to 1 hour

Secondary Outcomes (3)

• Tidal Volume

  up to 1 hour

• Respiratory Rate

  up to 1 hour

• Transcutaneous pCO2

  up to 1 hour

Study Arms (2)

NHF - NHF/CO2

EXPERIMENTAL

Patients with chronic respiratory failure are treated with nasal high flow during wakefulness. First with NHF (30l/min) alone, then NHF (30l/min) plus 1% CO2.

Device: Nasal High Flow (NHF)

NHF/CO2 - NHF

EXPERIMENTAL

Patients with chronic respiratory failure are treated with nasal high flow during wakefulness. First with NHF (30l/min) plus 1% CO2 , then NHF (30l/min) alone.

Device: Nasal High Flow (NHF)

Interventions

Nasal High Flow (NHF) DEVICE

Patients with chronic respiratory failure are treated for 1 h with NHF therapy and with individual O2 supplementation during wakefulness.

Also known as: AIRVO2

NHF - NHF/CO2; NHF/CO2 - NHF

Eligibility Criteria

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

You may qualify if:

• Hospitalized COPD patients GOLD (3 and 4) in stable phase after an acute exacerbation.
• Written informed consent is required for participation.

You may not qualify if:

• Acute respiratory failure with clinical instability or respiratory acidosis defined by pH\<7.35
• Severe acute physical illness that does not allow the subject to participate in a clinical trial
• Unable to give consent
• Language, cognitive, or other impairments that may prevent independent completion of questionnaires

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead

Study Sites (1)

Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, 45276, Germany

Location

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

Study Officials

• Georg Nilius, Professor

  Evang. Kliniken Essen-Mitte gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: February 27, 2021
• Primary Completion: November 12, 2021
• Study Completion: March 1, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

DE (1)