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Clinical Trials/NCT01509703
NCT01509703CompletedNot Applicable

Respiratory Physiology Measurements Under Transnasal High Flow Therapy in Patients With Tracheostoma After Long Term Ventilation

Institut für Pneumologie Hagen Ambrock eV2 sites in 1 country10 target enrollmentStarted: December 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
10
Locations
2
Primary Endpoint
Intratracheal pressure conditions

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Intratracheal endtidal CO2 concentration(2 hours)
  • Breathing frequency and tidal volume(2 hours)

Investigators

Sponsor
Institut für Pneumologie Hagen Ambrock eV
Sponsor Class
Industry
Responsible Party
Principal Investigator
Principal Investigator

Georg Nilius

Head of the department pneumology at the Helios clinic Hagen Ambrock

Helios Klinik Ambrock

Study Sites (2)

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