Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery

The Prevalence of Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity; Diastolic Dysfunction

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 Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of diastolic dysfunction	Prevalence of diastolic dysfunction according to American society of echocardiography definition	during surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Aphichat Suphathamwit, M.D., Mahidol university

Publications and helpful links

General Publications

• Cabrera Schulmeyer MC, Arriaza N. Good prognostic value of the intraoperative tissue Doppler-derived index E/e' after non-cardiac surgery. Minerva Anestesiol. 2012 Sep;78(9):1013-8. Epub 2012 Jun 14.
• Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013 Sep;26(9):921-64. doi: 10.1016/j.echo.2013.07.009. No abstract available.
• Aljaroudi W, Alraies MC, Halley C, Rodriguez L, Grimm RA, Thomas JD, Jaber WA. Impact of progression of diastolic dysfunction on mortality in patients with normal ejection fraction. Circulation. 2012 Feb 14;125(6):782-8. doi: 10.1161/CIRCULATIONAHA.111.066423. Epub 2012 Jan 18.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Morbid Obesity; Bariatric surgery; Diastolic dysfunction
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 2018_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No