Ultrasound Lung Fluid Responsiveness During Hysterectomy

Fluid Overload Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429751
• Other study ID #: MS/16.06.76
• Status: Completed
• Phase: N/A
• First received: February 5, 2018
• Last updated: February 9, 2018
• Start date: July 10, 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: February 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 1, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fluid Overload

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Oncology Center Mansoura University.	Mansourah.	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Alaa Mazy

Country where clinical trial is conducted

Egypt, 

Outcome

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