Hypoxia in Flight Simulation in Obese Patients

Completed

• Conditions: Obesity, COPD, OHS
• Interventions: Other: flight simulationin obese healthy adults or obese patients with or without COPD, OHS

• Registration Number: NCT02636465
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-12-16
• Last Update Submitted: 2015-12-16
• Study First Posted: 2015-12-21
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
desaturation (SaO2 in %) in flight simulation in obese patients	one hour each patient

Secondary Outcome Measures

Name	Time	Method
desaturation (SaO2 in %) in hypoxic chamber test versus hypoxia altitude Simulation test	one hour each patient

Trial Locations

Locations (1)

Bethanien Hospital; 🇩🇪 Solingen, Germany