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

NCT ID: NCT05053074

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-27
• Study Completion Date: 2022-03-01

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nasal High Flow (NHF)

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Nasal High Flow (NHF)

Intervention Type: DEVICE

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

Interventions

Nasal High Flow (NHF)

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

Intervention Type: DEVICE

Other Intervention Names

AIRVO2

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role: lead

Responsible Party

Georg Nilius, Prof DR med

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georg Nilius, Professor

Role: PRINCIPAL_INVESTIGATOR

Evang. Kliniken Essen-Mitte gGmbH

Locations

Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

NHFwake2020

Identifier Type: -

Identifier Source: org_study_id