Clinical trial NCT04128735: Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
Official title: The Prevalence of Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastolic Dysfunction
Morbid Obesity
Keywords: Diastolic dysfunction
Morbid Obesity
Bariatric surgery
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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)

Primary outcomes:
measure: Prevalence of diastolic dysfunction
timeFrame: during surgery
Secondary outcomes:
measure: Prevalence of other cardiac abnormalities
timeFrame: during surgery
measure: Incidence of cardiac adverse events
timeFrame: within 24 hours after surgery
measure: Incidence of pulmonary adverse events
timeFrame: within 24 hours after surgery
measure: Incidence of oral and airway trauma
timeFrame: within 24 hours after surgery
measure: Length of hospital stay
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Aphichat Suphathamwit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.