Ultrasound Lung Fluid Responsiveness During Hysterectomy

Ultrasound Lung Evaluation of Different Fluid Management Protocols in Patients Undergoing Laparoscopic Hysterectomy.

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload
• Intervention / Treatment: Drug: 30 ml/Kg/h crystalloid; Drug: 10 ml/Kg/h crystalloid

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah., Dakahlia, Egypt, 35516
      • Oncology Center Mansoura University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liberal fluid group; received 30 ml/Kg/h crystalloid for maximum 3 hours.	Drug: 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.
Active Comparator: Restrictive fluid group; received 10 ml /Kg/h crystalloids for maximum 3 hours.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of lung ultrasound B lines appearance.	Three or more comet lines appearance in a lung field. Two or more positive regions per side suggested a B-pattern. B -lines are defined as discrete laser-like vertical hyper-echoic artifacts that arise from the pleura line extend to the bottom of the screen without fading and move synchronously with lung sliding.	5 minutes after the end of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total volume of crystalloid infusion.	milliliter	Intraoperative.
The total volume of blood transfusion.	milliliter	Intraoperative.
The amount of blood loss.	milliliter, estimated from the weight of swaps and suction bottles.	Intraoperative.
The duration of surgery.	minutes. from the time of induction of anesthesia till extubation time.	intraoperative.
Central venous pressure	centimeter water.	Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Mean blood pressure	millimeter mercury.	Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Heart rate.	Beats per minute.	Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Peripheral oxygen saturation.	percent.	Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Hourly urine output.	milliliter,	intraoperative,
Arterial blood gases.	for arterial oxygen and carbon dioxide tensions in millimeter mercury, base excess level in millimole per liter.	15 minutes preoperative, 15 minutes postoperative.
Serum sodium level.	millimole per liter.	15 minutes preoperative, 15 minutes postoperative.
Serum potassium level.	millimole per liter.	15 minutes preoperative, 15 minutes postoperative.
Hemoglobin level.	milligram per deciliter.	15 minutes preoperative, 15 minutes postoperative.
Hematocrit value.	percent.	15 minutes preoperative, 15 minutes postoperative.

Collaborators and Investigators

• Sponsor: Alaa Mazy

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2016
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: lung ultrasound, fluid, hysterectomy, B lines
• Other Study ID Numbers: MS/16.06.76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No