Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01382927
First received: June 22, 2011
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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).


Condition
Obesity
Hip Arthroplasty
General Anesthesia
Spinal Anesthesia
Atelectasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • arterial pO2 on room air [ Time Frame: 24hrs ] [ Designated as safety issue: Yes ]
  • Center of Ventilation [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
    measured by EIT


Secondary Outcome Measures:
  • Peak Flow [ Time Frame: 24hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: April 2011
Groups/Cohorts
General Anesthesia
Spinal Anesthesia

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obese Patients aged 18-85, scheduled for elective hip arthroplasty

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382927

Locations
Germany
University Hospital Carl-Gustav-Carus Recruiting
Dresden, Germany, 01307
Contact: Oliver C Radke, MD, PhD, DEAA    +49 351 458-18040    oradke@pcat.de   
Principal Investigator: Oliver C Radke, MD, PhD, DEAA         
Sponsors and Collaborators
Technische Universität Dresden
  More Information

No publications provided

Responsible Party: Oliver C. Radke, MD, PhD, DEAA, Dpt of Anesthesia and Perioperative Care
ClinicalTrials.gov Identifier: NCT01382927     History of Changes
Other Study ID Numbers: SBVOBP
Study First Received: June 22, 2011
Last Updated: June 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on September 22, 2014