Intraoperative Fluid Management Guided by Internal Jugular Vein on Postoperative Complications in Abdominal Surgeries

NCT ID: NCT07041021

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-01-31

Brief Summary

This study investigates the role of respiratory variation in the internal jugular vein as a tool for intraoperative fluid management during abdominal surgeries under general anesthesia.

The purpose of this clinical trial is to reduce postoperative complications and improve patient outcomes through proper intraoperative fluid management.

The main question it aims to answer is: Can intraoperative fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries reduce postoperative complications? Research Hypothesis (Alternative Hypothesis): We hypothesize that fluid management guided by the respiratory variation of the internal jugular vein during abdominal surgeries can reduce postoperative complications.

The patients will be divided into two groups and randomized to receive either intraoperative fluid therapy guided by the respiratory variation of the internal jugular vein or standard fluid therapy. Postoperative complications, length of hospital stay, total amount of fluid administered intraoperatively, use of vasopressors in both groups, and incidence of hypotensive episodes will be recorded.

Detailed Description

Sonographic measurement of respiratory variation of IJV will be performed with a Philips CX50 ultrasound device (Philips Healthcare, Hamburg, Germany), equipped with a linear transducer. Respiratory variation of IJV will be measured by the same anesthesiologist with sufficient experience in ultrasound guided IJV cannulation. The anesthesiologist performing the ultrasound examinations will not be involved in this study and blinded to the hemodynamic parameters; a lead plate separated the monitor from the anesthesiologist and ultrasound device. The optimal short axis of the IJV will be obtained at the level of the cricoid cartilage by placement of the transducer perpendicular to the skin on the patient's neck in a transverse plane. The vein will be identified with color Doppler imaging as well as by compression. Ultrasound measurements will be performed on the left IJV, M-mode scan will be used to record the IJV diameter at the end of inspiration (IJVmax) and expiration (IJVmin) over an entire respiratory cycle. The images will be then frozen. The respiratory variation of IJV will be calculated with the following formula: IJV RV (%) = (IJVmax - IJVmin)/ (IJVmin) × 100%. The average values of IJVmax and IJVmin from three consecutive respiratory circles will be used in the analysis.

The finding of a small-diameter IJV (<1cm) and increased IJV RV (>18) suggest low-volume states. Conversely, a large IJV diameter (>2.1cm) and decreased IJV RV (<18) will suggest a high-volume state.

Conditions

Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Internal Jugular Vein (IJV) group (Study group)

In this group, fluid therapy will be guided by the respiratory variation of IJV throughout the surgery.

Group Type: ACTIVE_COMPARATOR

Respiratory variation of the Internal Jugular Vein (IJV)

Intervention Type: DIAGNOSTIC_TEST

In the study group, the fluid therapy will be guided by the respiratory variation (RV) of the Internal Jugular Vein (IJV) throughout surgery. Fluid maintenance will be continued as long as the IJV diameter is less than 2 cm and the IJV RV is more than 18. If the IJV diameter exceeds 2 cm and the IJV RV is less than 18, fluids will be stopped.

Control group

In this group, conventional fluid therapy will be given to ensure that the mean arterial blood pressure is equal to or more than 65 mmHg.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Respiratory variation of the Internal Jugular Vein (IJV)

In the study group, the fluid therapy will be guided by the respiratory variation (RV) of the Internal Jugular Vein (IJV) throughout surgery. Fluid maintenance will be continued as long as the IJV diameter is less than 2 cm and the IJV RV is more than 18. If the IJV diameter exceeds 2 cm and the IJV RV is less than 18, fluids will be stopped.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Patients' American Society of Anesthesiologists physical status (ASA) is I and II.

2. The target age group is 20 to 70 years old.

3. Patients scheduled for abdominal surgery under general anesthesia with normal renal function.

Exclusion Criteria

1. Refusal of the procedure or participation in the study.

2. Coagulopathy.

3. Pre-existing cardiac, renal, and respiratory diseases. 4-Internal jugular vein thrombosis

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Mohammad E Salama, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad E Salama, MD

Role: PRINCIPAL_INVESTIGATOR

Suez canal university hospitals

Locations

Suez Canal University Hospitals

Ismailia, Ismailia Governorate, Egypt

Site Status: NOT_YET_RECRUITING

Suez Canal University Hospitals

Ismailia, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammad E Salama, MD

Role: CONTACT

MohammadElhossieny88@med.suez.edu.eg

00201016865861

Adel A Hassan, MD

Role: CONTACT

adel.hassan@med.psu.edu.eg

00201007921234

Facility Contacts

Mohammad E Salama, MD

Role: primary

MohammadElhossieny88@med.suez.edu.eg

00201016865861

Mohammad E Salama, MD

Role: primary

MohammadElhossieny88@med.suez.edu.eg

+201016865861

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

5988#

Identifier Type: -

Identifier Source: org_study_id