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Respiratory Physiology Under High Flow Therapy

Sponsor
Institut für Pneumologie Hagen Ambrock eV (Industry)
Overall Status
Completed
CT.gov ID
NCT01509703
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
36
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: High flow therapy
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Respiratory Physiology Measurements Under Transnasal High Flow Therapy in Patients With Tracheostoma After Long Term Ventilation
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • AIRVO (Fisher and Paykel)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intratracheal pressure conditions [2 hours]

      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

    1. Intratracheal endtidal CO2 concentration [2 hours]

      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.

    2. Breathing frequency and tidal volume [2 hours]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Helios Klinik Hagen Ambrock Hagen NRW Germany 58091

    Sponsors and Collaborators

    • Institut für Pneumologie Hagen Ambrock eV

    Investigators

    • Principal Investigator: Georg Nilius, MD, Helios Klinik Hagen Ambrock, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Georg Nilius, Head of the department pneumology at the Helios clinic Hagen Ambrock, Helios Klinik Ambrock
    ClinicalTrials.gov Identifier:
    NCT01509703
    Other Study ID Numbers:
    • Trachea 2.0
    First Posted:
    Jan 13, 2012
    Last Update Posted:
    Mar 24, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Georg Nilius, Head of the department pneumology at the Helios clinic Hagen Ambrock, Helios Klinik Ambrock
    COPD
    Nasal High Flow Therapy
    tracheotomy stent
    tracheotomy
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Mar 24, 2015