ObesityNCT01382927
Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients
An observational study of Obesity and Hip Arthroplasty, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obesity, Hip Arthroplasty, General Anesthesia
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese Patients aged 18-85, scheduled for elective hip arthroplasty
Who may be able to join
- BMI >30
- age 18-85
- elective hip arthroplasty in general anesthesia or spinal anesthesia
Who cannot join
- pregnancy/breastfeeding
- allergies against drugs used for the anesthesia
- contraindications for EIT
- severe cardiac or pulmonary comorbidities
- unable to consent or understand/follow study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Carl-Gustav-Carus
Dresden, Germany, 01307
Oliver C Radke, MD, PhD, DEAA, +49 351 458-18040, oradke@pcat.de
Oliver C Radke, MD, PhD, DEAA
About this study
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).
- Conditions
- Obesity, Hip Arthroplasty, General Anesthesia, Spinal Anesthesia, Atelectasis
- Medical subject headings
- Obesity, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Not described | |
| Spinal Anesthesia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial pO2 on room air
Measured: 24hrs
Center of Ventilation
measured by EIT
Measured: 24hrs
Secondary outcomes (1)
Peak Flow
Measured: 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382927
- Sponsor's protocol ID
- SBVOBP
- Status last verified
- Jun 2011
- First submitted
- 22 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients
- ClinicalTrials.gov ID
- NCT01382927
- Acronym / sponsor ID
- SBVOBP
- Conditions
- Obesity, Hip Arthroplasty, General Anesthesia, Spinal Anesthesia, Atelectasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Apr 2011
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | – |
| Spinal Anesthesia | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese Patients aged 18-85, scheduled for elective hip arthroplasty
Key inclusion criteria (3 listed)
- BMI >30
- age 18-85
- elective hip arthroplasty in general anesthesia or spinal anesthesia
Key exclusion criteria (5 listed)
- pregnancy/breastfeeding
- allergies against drugs used for the anesthesia
- contraindications for EIT
- severe cardiac or pulmonary comorbidities
- unable to consent or understand/follow study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
arterial pO2 on room air
Time frame: 24hrs
Center of Ventilation
Time frame: 24hrs
measured by EIT
1 secondary outcome
Peak Flow
Time frame: 24hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Hip Arthroplasty, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial pO2 on room air (time frame: 24hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.