Ultrasound Lung Fluid Responsiveness During Hysterectomy

NCT ID: NCT03429751

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-10
• Study Completion Date: 2017-09-01

Brief Summary

Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific evidence on optimal intraoperative fluid management has resulted in large variations of administered fluid regimens in daily practice. The restricted perioperative intravenous fluid regimen reduces complications after elective surgeries, however other studies had shown that intraoperative liberal fluid administration improves postoperative organ functions and recovery and shortens hospital stay after elective surgeries.

Detailed Description

A review of patients undergoing major abdominal surgery, excluding high-risk patients, compared liberal and restrictive fluid regimens; concluded that it is difficult to define 'liberal' or 'restrictive' protocols in clinical practice. patients undergoing moderate-risk surgery seem to benefit from the more liberal fluid administration, while patients undergoing high-risk or major surgery seem to benefit from restrictive or conservative strategies. Lung ultrasound used for comparison between liberal and restrictive fluid therapy in laparoscopic hysterectomy patients by detecting the B-lines intraoperatively or immediately postoperatively. The aim is to evaluate the lung ultrasound as a guide for intraoperative fluid management, being an index for increased extravascular lung water (ECLW). This operation is a moderately complex procedure that implies the Trendelenburg position. This position - in addition to liberal fluids - will increase venous return and increase the challenge on the cardiac muscle under anesthesia in these patients.

Conditions

Fluid Overload

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Liberal fluid group

received 30 ml/Kg/h crystalloid for maximum 3 hours.

Group Type: EXPERIMENTAL

30 ml/Kg/h crystalloid

Intervention Type: DRUG

Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 30 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.

Restrictive fluid group

received 10 ml /Kg/h crystalloids for maximum 3 hours.

Group Type: ACTIVE_COMPARATOR

10 ml/Kg/h crystalloid

Intervention Type: DRUG

Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 10 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.

Interventions

30 ml/Kg/h crystalloid

Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 30 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.

Intervention Type: DRUG

10 ml/Kg/h crystalloid

Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 10 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female patients scheduled for an elective laparoscopic hysterectomy.
• American society of anesthesiologists status I-II.

Exclusion Criteria

• Patient refusal.
• Severe cardiac insufficiency (New York Heart Association IV, myocardial infarction 3 months).
• Valvular heart diseases.
• Renal insufficiency (GFR<60 ml/kg/1.73m2).
• Hepatic insufficiency (Albumin less than 3).
• Patient with previous or current history of pulmonary disease.
• History of allergy to anesthetic drugs.
• Obese patients (BMI>30).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alaa Mazy

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mazy

associate professor of anesthesia and surgical intensive care

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Oncology Center Mansoura University.

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MS/16.06.76

Identifier Type: -

Identifier Source: org_study_id