The Effect of İnferior Vena Cava Diameter and Collapsibility Index on Fluid Management

Hypovolemia Clinical Trial

Official title:

The Effect of Ultrasonography-Assisted İnferior Vena Cava Diameter and Collapsibility Index on Fluid Management in Gynecological Cases Performing Pelvic Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06231472
• Other study ID #: 2022/0263
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Before general anesthesia, patients are usually taken into surgery after 8-10 hours of fasting. During this fasting period, patients may experience fluid deficit. Nowadays, inferior vena cava (IVC) imaging with ultrasonography (USG) and inferior vena cava collapsibility index (IVCCI) calculation are widely used non-invasive, easy, fast and reliable methods for evaluating fluid deficit. In this study, whether IVC diameter and IVCCI displayed before general anesthesia can predict hypotension developing after general anesthesia, whether preoperative fluid infusion contributes to patient hemodynamics, also we aim are IVC diameter and IVCCI investigate the correlation between with used to predict other fluid deficits, pulse pressure change (PPV), perfusion index (PI), pleth variability index (PVI) and peripheral blood hemoglobin (SpHb).

Description:

The study was conducted as a prospective randomized controlled study. The study, age 18-75, American Society of Anesthesiologists scores (ASA) I-II- III who, will be under general anehestesia pelvic surgery performed 122 patients were included. 10 patients were excluded from the study due to insufficient image quality and 2 patients were excluded due to the initiation of vasoactive drug infusion. Two groups were formed from the patients evaluated, with 55 people in each group. They were classified as those who received intravenous fluid maintenance during the preoperative fasting period (group A) and those who were given a calculated amount of fluid intraoperatively (group B). The maximum IVC diameter (dIVCmax) and minimum IVC diameter (dIVCmin) of the patients were measured in the preoperative and postoperative periods. IVKKI was calculated [(dIVKmax- dIVKmin)/dIVKmax ×100%]. Those with serious cardiac disease (patients not in sinus rhythm, pulmonary hypertension, unstable angina or ejection fraction less than 40%), obese patients, body mass index (BMI) >35, patients whose IVC cannot be visualized, increased abdominal pressure, major peripheral artery disease, patients with a pacemaker, using angioreceptor blockers, patients with a hypotensive course (those with systolic arterial pressure <30 mmHg despite inotropic infusion over 1mcg/kg/min), patients with severe hypertension (systolic blood pressure >180 mmHg, diastole>110 mmHg). ), patients with open wounds in the USG area, patients with body temperature >37.5 °C, patients with partial carbon dioxide pressure (PaCO2) in arterial blood gas >60 mmHg, patients with mental retardation and limited cooperation, and patients who did not agree to participate in the study were not included in the study. Peripheral oxygen saturation (SpO2), PPV PI, PVI, SpHb, electrocardiography (ECG) and invasive blood pressure monitoring were performed on the patients. Blood pressure was measured by invasive (radial artery) method. Hypotension was considered as systolic blood pressure below 90 mmHg, mean arterial pressure (MAP) decreasing by more than 30% compared to the baseline value or below 60 mmHg, or a combination of the two.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Gynaecological pelvic surgery patients aged 18-75 years

• Patients with an American Society of Anaesthetists score of 1-2-3

Exclusion Criteria:

• Those with serious cardiac disease

• Obese harvests are those with BMI >35

• Those with major peripheral vascular disease

• Those with increased abdominal pressure

• Patients with pacemakers

• Patients using angioreceptor blockers

• Patients whose inferior vena cava cannot be visualized

• Patients with a hypotensive course (those whose persistence is <30 mmHg despite inotrope infusion over 1mcg/kg/min)

• Patients with severe hypertension (systolic 180 mmhg, diastolic>110 mmhg)

• Those with open wounds in the USG area

• Those with body temperature >37.5

• Those with pco2 > 60 mmhg in arterial blood gas

• Patients with mental retardation and limited cooperation

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Procedure:
• peroperative inferior vena cava measurement
peroperative inferior vena cava measurement

Locations

Country	Name	City	State
Turkey	Istanbul Professor Doctor Süleyman Yalçin City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Burgac

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	do inferior vena cava diameter measurement and inferior vena cava callobsibility index predict hypotension after induction of general anaesthesia	The inferior vena cava will be visualised through the subxiphoid window. M-mode measurement will be made two cm from the hepatic vein. The collapsibility index will be calculated as a % value by dividing the diameter of the largest vena cava and the diameter of the smallest vena cava by the diameter of the largest vena cava.; In patients, a smaller inferior vena cava diameter and a larger collabsibility index will predict the development of hypotension.	The diameter of the inferior vena cava will be assessed in the preoperative preparation area before the patient is taken to the operating table.
Primary	does fluid infusion in the preoperative period protect from hypotension after induction of general anaesthesia	Patients in group a will receive maintenance fluid infusion calculated according to the capilogram during the preoperative fasting period. Group b patients will not receive any intervention. It will be evaluated whether there is a difference in the development of hypotension between both groups of patients. Hypotension will be defined as a systolic blood pressure below 90 mmHg, a decrease in mean arterial pressure by 30% or more from baseline or a decrease in mean arterial pressure below 60 mmHg.	Blood pressure measurement will be recorded before and after induction.