Suspended

Evaluation of Esophageal Pressures and Reflux in Obese Patients Before and During Anesthesia Using High-resolution Solid-state Manometry

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Device Data

Collected from today forward - Prospective
Device
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 60 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2012
See protocol details

Summary

Principal SponsorÖrebro University, Sweden
Last updated: November 5, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01703897
Principal SponsorÖrebro University, Sweden
Last updated: November 5, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightObesity

Criteria

4 inclusion criteria required to participate
ASA classification I-III
BMI > 35
Male and female patients
aged 18-60 years
2 exclusion criteria prevent from participating
Gastro-esophageal reflux disease
Use of drugs that interfere with esophageal motility

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Anesthesiology and Intensive care, University Hospital of Örebro

Örebro, SwedenOpen Department of Anesthesiology and Intensive care, University Hospital of Örebro in Google Maps
SuspendedOne Study Center