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NCT Number: NCT05053074

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, 45276, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: AIRVO2

Primary outcomes

  1. Minute Ventilation

    Time frame: up to 1 hour

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

Secondary outcomes

  1. Tidal Volume

    Time frame: up to 1 hour

    Difference in tidal volume (VT) under NHF versus NHF/CO2

  2. Respiratory Rate

    Time frame: up to 1 hour

    Difference in respiratory rate under NHF versus NHF/CO2.

  3. Transcutaneous pCO2

    Time frame: up to 1 hour

    Difference in transcutaneous pCO2 under NHF versus NHF/CO2.

Sponsors and collaborators

Lead sponsor

Institut für Pneumologie Hagen Ambrock eV

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 22, 2021
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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