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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01382927
Other study ID # SBVOBP
Secondary ID
Status Recruiting
Phase N/A
First received June 22, 2011
Last updated June 24, 2011
Start date April 2011

Study information

Verified date June 2011
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

General anesthesia (GA) and paralysis are factors which facilitate atelectasis formation, especially in obese patients. Spontaneous breathing can reduce the amount of atelectasis. In this study, the investigators are comaparing obese patients undergoing hip arthroplasty in GA versus spinal anesthesia. Distribution of ventilation during and after anesthesia is assessed by eletrical impedance tomography (EIT).


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- BMI >30

- age 18-85

- elective hip arthroplasty in general anesthesia or spinal anesthesia

Exclusion Criteria:

- pregnancy/breastfeeding

- allergies against drugs used for the anesthesia

- contraindications for EIT

- severe cardiac or pulmonary comorbidities

- unable to consent or understand/follow study

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Germany University Hospital Carl-Gustav-Carus Dresden

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary arterial pO2 on room air 24hrs Yes
Primary Center of Ventilation measured by EIT 24hrs No
Secondary Peak Flow 24hrs No
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