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Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT04128735
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.

Condition or disease
Diastolic Dysfunction Morbid Obesity

Detailed Description:

Morbidly obese patients are at risk for both respiratory and cardiovascular abnormalities. Many cardiac problems were previously reported including left ventricular hypertrophy, right and left ventricular systolic dysfunction etc. Diastolic cardiac dysfunction can be found in normal left ventricular systolic function and can lead to diastolic heart failure postoperatively.

Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge (thick chest wall, narrowing of inter-rib space), therefore the prevalence of this problem may be underestimated. Transesophageal echocardiogram provides better cardiac view, but requires sedation during procedure. So, it is not practical for out-patient setting. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.


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Study Type : Observational
Estimated Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prevalence of Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of diastolic dysfunction [ Time Frame: during surgery ]
    Prevalence of diastolic dysfunction according to American society of echocardiography definition


Secondary Outcome Measures :
  1. Prevalence of other cardiac abnormalities [ Time Frame: during surgery ]
    Number of patients with other cardiac abnormalities, both structural and functional abnormalities

  2. Incidence of cardiac adverse events [ Time Frame: within 24 hours after surgery ]
    Number of patients with cardiac adverse event: myocardial ischemia, pulmonary edema

  3. Incidence of pulmonary adverse events [ Time Frame: within 24 hours after surgery ]
    Number of patients experienced aspiration, desaturation, re-intubation

  4. Incidence of oral and airway trauma [ Time Frame: within 24 hours after surgery ]
    Number of patients with new loose teeth, sore throat, difficult to swallow, hoarseness of voice

  5. Length of hospital stay [ Time Frame: up to 5 days ]
    duration of hospital stay



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Criteria for patient enrolled to bariatric surgery in Siriraj hospital

  • BMI more than 40 kg/m2
  • BMI more than 35 kg/m2 with hypertension, type 2 diabetes, hyperlipidemia, obstructive sleep apnea, chronic arthritis
  • age between 18 - 70 years old
Criteria

Inclusion Criteria:

  • Every patient scheduled for bariatric surgery in Siriraj hospital

Exclusion Criteria:

  • Patient refusal
  • patient with contraindication for transesophageal echocardiogram such as preexisting esophageal disease, recent upper gastrointestinal bleeding, coagulopathy, etc. (according to American society of Echocardiography guideline)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128735


Contacts
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Contact: Aphichat Suphathamwit, M.D. 66982786069 aphichatsup99@gmail.com
Contact: Chanakan Jerdmathawut, M.D. 66870818515 chanakan.jerd@gmail.com

Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Aphichat Suphathamwit, M.D. Mahidol University

Publications of Results:
Other Publications:
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04128735     History of Changes
Other Study ID Numbers: 2018_2
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Diastolic dysfunction
Morbid Obesity
Bariatric surgery
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms