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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053074
• Other study ID #: NHFwake2020
• Status: Completed
• Phase: N/A
• Start date: February 27, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2023
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2022
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
Germany	Evang. Kliniken Essen-Mitte gGmbH	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minute Ventilation	Difference in respiratory minute volume under NHF versus NHF/CO2.	up to 1 hour
Secondary	Tidal Volume	Difference in tidal volume (VT) under NHF versus NHF/CO2	up to 1 hour
Secondary	Respiratory Rate	Difference in respiratory rate under NHF versus NHF/CO2.	up to 1 hour
Secondary	Transcutaneous pCO2	Difference in transcutaneous pCO2 under NHF versus NHF/CO2.	up to 1 hour