Hypoxia in Flight Simulation in Obese Patients

December 16, 2015 updated by: Wissenschaftliches Institut Bethanien e.V
The purpose of this pilot study is to determine whether obese adults,obese (BMI>30 kg/m2) with obesity hypoventilation or obese COPD-patients do undergo oxygen desaturation under flight simulation and if the hypoxic altitude simulation test is as effective as the hypoxic chamber test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Solingen, Germany, 42699
        • Bethanien Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

obese (BMI>30 kg/m2) healthy adults, obese patients with obesity hypoventilation Syndrome, obese patients with COPD

Description

Inclusion Criteria:

  • age ≥ 18 years
  • patients with COPD (GOLD I-IV Group A-D) with obesity (BMI> 30kg/m2), obese healthy adults with BMI> 30kg /m2, patients with Obesity hypoventilation syndrome
  • informed consent provided

Exclusion Criteria:

  • patients less than BMI <30 kg/m2 with or without COPD, OHS
  • Age < 18 years
  • pregnancy, lactation
  • any medical, psychological or other condition restricting the patient's ability to provide informed consent
  • participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obese healthy adults
persons with BMI> 30 kg/m2
Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS
Other Names:
  • flight simulation
obese COPD patients
COPD-patients (GOLD I-IV Group A-D) with BMI> 30 kg/m2
Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS
Other Names:
  • flight simulation
OHS-patients
patients with defined OHS: BMI>30 kg/m2 and sleep related breathing disease, no COPD
Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS
Other Names:
  • flight simulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
desaturation (SaO2 in %) in flight simulation in obese patients
Time Frame: one hour each patient
one hour each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
desaturation (SaO2 in %) in hypoxic chamber test versus hypoxia altitude Simulation test
Time Frame: one hour each patient
one hour each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wissenschaftliches Institut Bethanien e.V

Collaborators

Deutsche Luft und Raumfahrt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 21, 2015

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI_105/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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