Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04128735
• Other study ID #: 2018_2
• Status: Completed
• Start date: October 30, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 28, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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.111.06 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of diastolic dysfunction	Prevalence of diastolic dysfunction according to American society of echocardiography definition	during surgery
Secondary	Prevalence of other cardiac abnormalities	Number of patients with other cardiac abnormalities, both structural and functional abnormalities	during surgery
Secondary	Incidence of cardiac adverse events	Number of patients with cardiac adverse event: myocardial ischemia, pulmonary edema	within 24 hours after surgery
Secondary	Incidence of pulmonary adverse events	Number of patients experienced aspiration, desaturation, re-intubation	within 24 hours after surgery
Secondary	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
Secondary	Length of hospital stay	duration of hospital stay	up to 5 days