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OpenTrials
Completed

NCT Number: NCT04128735

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Prevalence of diastolic dysfunction

    Time frame: during surgery

    Prevalence of diastolic dysfunction according to American society of echocardiography definition

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 16, 2019
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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