Respiratory Physiology Under High Flow Therapy
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|ClinicalTrials.gov Identifier: NCT01509703|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Procedure: High flow therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|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 :||December 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|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)
- Intratracheal pressure conditions [ Time Frame: 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.
- Intratracheal endtidal CO2 concentration [ Time Frame: 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.
- Breathing frequency and tidal volume [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509703
|Helios Klinik Hagen Ambrock|
|Hagen, NRW, Germany, 58091|
|Principal Investigator:||Georg Nilius, MD||Helios Klinik Hagen Ambrock, Germany|