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Respiratory Physiology Under High Flow Therapy

This study is currently recruiting participants.
Verified September 2012 by Institut für Pneumologie Hagen Ambrock eV
Sponsor:
Information provided by (Responsible Party):
Georg Nilius, Helios Klinik Ambrock
ClinicalTrials.gov Identifier:
NCT01509703
First received: December 22, 2011
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Procedure: High flow therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Respiratory Physiology Measurements Under Transnasal High Flow Therapy in Patients With Tracheostoma After Long Term Ventilation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut für Pneumologie Hagen Ambrock eV:

Primary Outcome Measures:
  • Intratracheal pressure conditions [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Intratracheal endtidal CO2 concentration [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The effects of high flow transnasal insufflation on endtidal CO2 concentration is measured with the AD Instruments gas analyser and continuously recorded breath by breath.

  • Breathing frequency and tidal volume [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    The effects of high flow transnasal insufflation on breathing frequency and tidal volume is measured with the Viasys Respitrace calibrated belt system and continuously recorded breath by breath.


Estimated Enrollment: 10
Study Start Date: December 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High flow therapy Procedure: High flow therapy
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.
Other Name: AIRVO (Fisher and Paykel)

Detailed Description:

Ten patients, who are supplied with a tracheostomy stent (placeholder) for reinsertions after long term ventilation will be treated for a short time during the day with the nasal high flow system AIRVO at different flow rates (15, 30, 45L/min) to estimate possible long term implications of high flow treatment.

Respiration is measured by impedance plethysmography with a calibrated belt system (Respitrace, VIASYS). Pressure and end tidal CO2 concentration is measured inside of the placeholder.

The order of the high flow rates (15, 30, 45L/min) is randomized; each flow rate is measured for 15 minutes. A wash out time of ten minutes is planned after each phase. In this time the patient breathes his individual oxygen flow rate with attention to the oxygen saturation, which should not exceed 96%. Transcutaneous PCO2 and SpO2 is monitored with TOSCA during the study.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Incapable of giving consent
  • Any other severe or acute physical illness which requires intensive medical care
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509703

Contacts
Contact: Georg Nilius, MD 0049 2331 974 2000 georg.nilius@helios-kliniken.de
Contact: Ulrike Domanski 0049 2331 974 2080 ulrike.domanski@helios-kliniken.de

Locations
Germany
Helios Klinik Hagen Ambrock Recruiting
Hagen, NRW, Germany, 58091
Contact: Georg Nilius, MD     0049 2331 974 2000     georg.nilius@helios-kliniken.de    
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
Investigators
Principal Investigator: Georg Nilius, MD Helios Klinik Hagen Ambrock, Germany
  More Information

No publications provided

Responsible Party: Georg Nilius, Head of the department pneumology at the Helios clinic Hagen Ambrock, Helios Klinik Ambrock
ClinicalTrials.gov Identifier: NCT01509703     History of Changes
Other Study ID Numbers: Trachea 2.0
Study First Received: December 22, 2011
Last Updated: September 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut für Pneumologie Hagen Ambrock eV:
COPD
Nasal High Flow Therapy
tracheotomy stent
tracheotomy

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013