The Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Movement in Female Patients

NCT05703321 | Unknown

• 1 other identifier: 2022/185
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Background Fasting for 6 hours is required for the patients regarding the preparation of the operation and preparation for anesthesia. It is already known that this fasting period affects volume. Although Tricuspid Annular Plane Systolic Movement (TAPSE) is an echocardiographic parameter showing Right Ventricular (RV) systolic function, its relationship with volume is discussed in recent years. In the present study, the relationship between TAPSE and volume, and whether there is a change in preoperative fasting and right ventricular functions will be evaluated. Methods The study was started between 21.11.2022 and 21.05.2023 in Aydın Maternity and Child Hospital after approval was received from the Non-Invasive Clinical Research Ethics Committee. A total of 21 patients were planned to be included in this prospective observational study. Transthoracic echocardiography will be performed in patients aged 18-65 years who will undergo elective procedures under anesthesia, and in full patients the day before surgery. Those who are pregnant, patients with known or prospective severe valvular disease, severe pulmonary hypertension, acute myocardial infarction, dilated and hypertrophic cardiomyopathy, and non-sinus rhythm will be excluded from the study. Transthoracic echocardiography will be performed on the patients, and the relationship between TAPSE and volume and whether there is a change in preoperative fasting and right ventricular functions will be evaluated.

Conditions

TAPSE

Keywords

Preoperative Fasting; volume; Tricuspid Annular Plane Systolic Movement; right ventricle function

Outcome Measures

Primary Outcomes (1)

• TAPSE volume

  TAPSE, which is the right ventricular systolic function value, decreases after fasting, which is desired before the surgery

  6 month

Secondary Outcomes (1)

• fasting RV function

  6 month

Interventions

preoperative fasting BEHAVIORAL

Fasting for 6 hours is required for the patients regarding the preparation of the operation and preparation for anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: because , our hospital is maternity hospital.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

who will undergo elective procedures under anesthesia

You may qualify if:

• ASA 1-2
• Being between the ages of 18-65
• Having no peroperative hydration
• Preoperative sedative not given
• No known heart disease

You may not qualify if:

• Being pregnant
• Post cardiac surgery
• Severe pulmonary hypertension
• Severe valve disease
• Hypertrophic or dilated cardiomyopathy
• Presence of acute myocardial infarction
• Non-sinus rhythm

Sponsors & Collaborators

• Aydin Maternity and Child Health Hospital: lead

Study Sites (1)

Aydin Maternity and Child Health Hospital

Aydin, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 30, 2023
• Study Start: November 21, 2022
• Primary Completion: May 21, 2023
• Study Completion: May 21, 2023
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

TU (1)