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

Nasal High Flow (NHF) Bei COPD - Effekte Auf Die Ventilation im Wachzustand

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: Nasal High Flow (NHF)

Detailed Description

In this controlled randomized crossover trial, 10 stable patients with chronic obstructive respiratory disease (COPD) are treated with Nasal High Flow (NHF) therapy during wakefulness. NHF treatment will inevitably result in increased upper airway washout and thus in a slight reduction of PaCO2 of approximately 2 mmHg. For compensation, a small amount of CO2 is added to the inhaled air during this experimental situation, which keeps the patients' PaCO2 stable. This will allow to examine the effects of NHF therapy on respiratory rate, tidal volume and work of breathing, that are not attributable to the CO2 washout effect.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45276
      • Evang. Kliniken Essen-Mitte gGmbh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NHF - NHF/CO2; 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); Patients with chronic respiratory failure are treated for 1 h with NHF therapy and with individual O2 supplementation during wakefulness.; Other Names: AIRVO2
Experimental: NHF/CO2 - NHF; 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); Patients with chronic respiratory failure are treated for 1 h with NHF therapy and with individual O2 supplementation during wakefulness.; Other Names: AIRVO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute Ventilation	Difference in respiratory minute volume under NHF versus NHF/CO2.	up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal Volume	Difference in tidal volume (VT) under NHF versus NHF/CO2	up to 1 hour
Respiratory Rate	Difference in respiratory rate under NHF versus NHF/CO2.	up to 1 hour
Transcutaneous pCO2	Difference in transcutaneous pCO2 under NHF versus NHF/CO2.	up to 1 hour

Collaborators and Investigators

• Sponsor: Institut für Pneumologie Hagen Ambrock eV
• Investigators: Principal Investigator: Georg Nilius, Professor, Evang. Kliniken Essen-Mitte gGmbh

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2021
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Tidal Volume; Nasal High Flow; PaCO2; Washout Effect
• Other Study ID Numbers: NHFwake2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No