Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery

Completed

• Conditions: Diastolic Dysfunction; Morbid Obesity

• Registration Number: NCT04128735
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2019-10-30
• Primary Completion: 2022-12-30
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of diastolic dysfunction	during surgery	Prevalence of diastolic dysfunction according to American society of echocardiography definition

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 5 days	duration of hospital stay
Prevalence of other cardiac abnormalities	during surgery	Number of patients with other cardiac abnormalities, both structural and functional abnormalities
Incidence of pulmonary adverse events	within 24 hours after surgery	Number of patients experienced aspiration, desaturation, re-intubation
Incidence of cardiac adverse events	within 24 hours after surgery	Number of patients with cardiac adverse event: myocardial ischemia, pulmonary edema
Incidence of oral and airway trauma	within 24 hours after surgery	Number of patients with new loose teeth, sore throat, difficult to swallow, hoarseness of voice

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand