Ultrasound Lung Fluid Responsiveness During Hysterectomy

Not Applicable

Completed

• Conditions: Fluid Overload
• Interventions: Drug: 30 ml/Kg/h crystalloid; Drug: 10 ml/Kg/h crystalloid

• Registration Number: NCT03429751
• Lead Sponsor: Alaa Mazy

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.

Study Timeline

• Study Start: 2016-07-10
• Primary Completion: 2017-07-10
• Study Completion: 2017-09-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-09
• Last Update Submitted: 2018-02-09
• Study First Posted: 2018-02-12
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal fluid group	30 ml/Kg/h crystalloid	received 30 ml/Kg/h crystalloid for maximum 3 hours.
Restrictive fluid group	10 ml/Kg/h crystalloid	received 10 ml /Kg/h crystalloids for maximum 3 hours.

Primary Outcome Measures

Name	Time	Method
The rate of lung ultrasound B lines appearance.	5 minutes after the end of surgery.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oncology Center Mansoura University.; 🇪🇬 Mansourah., Dakahlia, Egypt