ObesityNCT01703897
Esophageal Manometry and Impedance Study in Obese Patients Before and During Anesthesia
An observational study of Obesity, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Manometry and Impedance analysis
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Obese patients
Who may be able to join
- Male and female patients
- aged 18-60 years
- BMI>35
- ASA classification I-III
Who cannot join
- Use of drugs that interfere with esophageal motility
- Gastro-esophageal reflux disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Anesthesiology and Intensive care, University Hospital of Örebro
Örebro, 70162
About this study
Official title: Evaluation of Esophageal Pressures and Reflux in Obese Patients Before and During Anesthesia Using High-resolution Solid-state Manometry
The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.
Read the detailed description
Obesity is an increasing heath problem in western countries and is associated with increased risks during anesthesia.
Using high-resolution solid-state manometry the investigators aim to study esophageal pressures and measure the incidence of regurgitation of gastric contents during anesthesia induction in obese patients. The investigators aim to include 16 obese patients, with BMI > 35, undergoing laparoscopic gastric by-pass.
- Conditions
- Obesity
- Being tested
- Manometry and Impedance analysis
- Keywords
- gastric by-pass surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manometry and Impedance analysisDevice
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Not described Receives: Device: Manometry and Impedance analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal pressures after laparoscopic gastric by pass
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startOct 2012
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex de Leon, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703897
- Sponsor's protocol ID
- Linde-Imped
- Status last verified
- Nov 2014
- First submitted
- 8 Oct 2012
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Esophageal Pressures and Reflux in Obese Patients Before and During Anesthesia Using High-resolution Solid-state Manometry
- ClinicalTrials.gov ID
- NCT01703897
- Acronym / sponsor ID
- Linde-Imped
- Conditions
- Obesity
- Keywords
- gastric by-pass surgery
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- Oct 2012
- First posted
- 11 Oct 2012 (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.
The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.
Detailed description
Obesity is an increasing heath problem in western countries and is associated with increased risks during anesthesia.
Using high-resolution solid-state manometry the investigators aim to study esophageal pressures and measure the incidence of regurgitation of gastric contents during anesthesia induction in obese patients. The investigators aim to include 16 obese patients, with BMI > 35, undergoing laparoscopic gastric by-pass.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Device: Manometry and Impedance analysis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Obese patients
Key inclusion criteria (4 listed)
- Male and female patients
- aged 18-60 years
- BMI>35
- ASA classification I-III
Key exclusion criteria (2 listed)
- Use of drugs that interfere with esophageal motility
- Gastro-esophageal reflux disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manometry and Impedance analysis | Device | Obese patients |
Primary outcome
Esophageal pressures after laparoscopic gastric by pass
Time frame: 2 years after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Örebro University, Sweden at 1 site in Sweden.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 5 Nov 2014. 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 Sweden. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal pressures after laparoscopic gastric by pass (time frame: 2 years after surgery). 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 5 Nov 2014.