Ultrasound Lung Fluid Responsiveness During Hysterectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fluid Overload

Intervention / Treatment
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* Drug: 30 ml/Kg/h crystalloid
* Drug: 10 ml/Kg/h crystalloid


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung ultrasound, fluid, hysterectomy, B lines