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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05053074
Enrollment
10
Registered
2021-09-22
Start date
2021-02-27
Completion date
2022-03-01
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

Nasal High Flow, PaCO2, Tidal Volume, Washout Effect

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.

Interventions

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

Sponsors

Institut für Pneumologie Hagen Ambrock eV
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Minute Ventilationup to 1 hourDifference in respiratory minute volume under NHF versus NHF/CO2.

Secondary

MeasureTime frameDescription
Transcutaneous pCO2up to 1 hourDifference in transcutaneous pCO2 under NHF versus NHF/CO2.
Tidal Volumeup to 1 hourDifference in tidal volume (VT) under NHF versus NHF/CO2
Respiratory Rateup to 1 hourDifference in respiratory rate under NHF versus NHF/CO2.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026