Respiratory Physiology Under High Flow Therapy

NCT01509703 | Completed

• 1 other identifier: Trachea 2.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to gain knowledge about effects of high flow transnasal insufflation on various breathing parameters like intratracheal pressure conditions, CO2 elimination, breathing frequency and tidal volume.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Nasal High Flow Therapy; tracheotomy stent; tracheotomy

Outcome Measures

Primary Outcomes (1)

• Intratracheal pressure conditions

  The effects of high flow transnasal insufflation on intratracheal pressure conditions is measured with the Hans Rudolph Inc. pressure amplifier and continuously recorded breath by breath.

  2 hours

Secondary Outcomes (2)

• Intratracheal endtidal CO2 concentration

  2 hours

• Breathing frequency and tidal volume

  2 hours

Study Arms (1)

High flow therapy

EXPERIMENTAL

Procedure: High flow therapy

Interventions

High flow therapy PROCEDURE

Each patient is treated with nasal high flow at different flow rates (15, 30, 45L/min). The order of flow rates is randomized. Each flow rate will be used for 15 minutes. A wash out time of ten minutes is planned after each phase, during which the patient uses his his individual oxygen flow.

Also known as: AIRVO (Fisher and Paykel)

High flow therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in a stable weaning phase after long term ventilation
• Patients supplied with tracheostomy stent (placeholder)
• Patients in stable respiratory situation

You may not qualify if:

• Incapable of giving consent
• Any other severe or acute physical illness which requires intensive medical care

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead

Study Sites (1)

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Georg Nilius, MD

  Helios Klinik Hagen Ambrock, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department pneumology at the Helios clinic Hagen Ambrock

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 13, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

DE (1)