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Respiratory Physiology Under High Flow Therapy

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
High flow therapy
Sponsored by
Institut für Pneumologie Hagen Ambrock eV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Nasal High Flow Therapy, tracheotomy stent, tracheotomy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helios Klinik Hagen Ambrock

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High flow therapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intratracheal endtidal CO2 concentration
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
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.

Full Information

First Posted
December 22, 2011
Last Updated
March 23, 2015
Sponsor
Institut für Pneumologie Hagen Ambrock eV
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1. Study Identification

Unique Protocol Identification Number
NCT01509703
Brief Title
Respiratory Physiology Under High Flow Therapy
Official Title
Respiratory Physiology Measurements Under Transnasal High Flow Therapy in Patients With Tracheostoma After Long Term Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Nasal High Flow Therapy, tracheotomy stent, tracheotomy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High flow therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
High flow therapy
Other Intervention Name(s)
AIRVO (Fisher and Paykel)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intratracheal pressure conditions
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Intratracheal endtidal CO2 concentration
Description
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.
Time Frame
2 hours
Title
Breathing frequency and tidal volume
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Nilius, MD
Organizational Affiliation
Helios Klinik Hagen Ambrock, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Hagen Ambrock
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany

12. IPD Sharing Statement

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Respiratory Physiology Under High Flow Therapy

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