- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01382927
Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients
June 24, 2011 updated by: Technische Universität Dresden
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).
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
16
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
-
-
-
Dresden, Germany, 01307
- Recruiting
- University Hospital Carl-Gustav-Carus
-
Contact:
- Oliver C Radke, MD, PhD, DEAA
- Phone Number: +49 351 458-18040
- Email: oradke@pcat.de
-
Principal Investigator:
- Oliver C Radke, MD, PhD, DEAA
-
-
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 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Obese Patients aged 18-85, scheduled for elective hip arthroplasty
Description
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 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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
General Anesthesia
|
|
Spinal Anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
arterial pO2 on room air
Time Frame: 24hrs
|
24hrs
|
|
|
Center of Ventilation
Time Frame: 24hrs
|
measured by EIT
|
24hrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Peak Flow
Time Frame: 24hrs
|
24hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2011
Study Registration Dates
First Submitted
June 22, 2011
First Submitted That Met QC Criteria
June 24, 2011
First Posted (Estimate)
June 27, 2011
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 24, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBVOBP
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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