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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: Nasal High Flow (NHF)

• Registration Number: NCT05053074
• Lead Sponsor: Institut für Pneumologie Hagen Ambrock eV

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.

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 Timeline

• Study Start: 2021-02-27
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Primary Completion: 2021-11-12
• Study Completion: 2022-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NHF - NHF/CO2	Nasal High Flow (NHF)	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.
NHF/CO2 - NHF	Nasal High Flow (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.

Primary Outcome Measures

Name	Time	Method
Minute Ventilation	up to 1 hour	Difference in respiratory minute volume under NHF versus NHF/CO2.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Evang. Kliniken Essen-Mitte gGmbH; 🇩🇪 Essen, NRW, Germany