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Respiratory Physiology Under High Flow Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 18, 2014
Last verified: February 2014

December 22, 2011
February 18, 2014
December 2011
December 2014   (final data collection date for primary outcome measure)
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.
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 continously recorded breath by breath.
Complete list of historical versions of study NCT01509703 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 continously 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 continously recorded breath by breath
Not Provided
Not Provided
 
Respiratory Physiology Under High Flow Therapy
Respiratory Physiology Measurements Under Transnasal High Flow Therapy in Patients With Tracheostoma After Long Term Ventilation

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Chronic Obstructive Pulmonary Disease
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)
Experimental: High flow therapy
Intervention: Procedure: High flow therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
February 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
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
Germany
 
NCT01509703
Trachea 2.0
No
Georg Nilius, Helios Klinik Ambrock
Institut für Pneumologie Hagen Ambrock eV
Not Provided
Principal Investigator: Georg Nilius, MD Helios Klinik Hagen Ambrock, Germany
Institut für Pneumologie Hagen Ambrock eV
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP