Respiratory Physiology Under High Flow Therapy

NCT ID: NCT01509703

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High flow therapy

Group Type EXPERIMENTAL

High flow therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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AIRVO (Fisher and Paykel)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role lead

Responsible Party

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Georg Nilius

Head of the department pneumology at the Helios clinic Hagen Ambrock

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg Nilius, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Hagen Ambrock, Germany

Locations

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Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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Trachea 2.0

Identifier Type: -

Identifier Source: org_study_id

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