Clinical trial NCT03429751: Ultrasound Lung Fluid Responsiveness During Hysterectomy
Official title: Ultrasound Lung Evaluation of Different Fluid Management Protocols in Patients Undergoing Laparoscopic Hysterectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Keywords: lung ultrasound, fluid, hysterectomy, B lines
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: The rate of lung ultrasound B lines appearance.
timeFrame: 5 minutes after the end of surgery.
Secondary outcomes:
measure: The total volume of crystalloid infusion.
timeFrame: Intraoperative.
measure: The total volume of blood transfusion.
timeFrame: Intraoperative.
measure: The amount of blood loss.
timeFrame: Intraoperative.
measure: The duration of surgery.
timeFrame: intraoperative.
measure: Central venous pressure
timeFrame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
measure: Mean blood pressure
timeFrame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
measure: Heart rate.
timeFrame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
measure: Peripheral oxygen saturation.
timeFrame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
measure: Hourly urine output.
timeFrame: intraoperative,
measure: Arterial blood gases.
timeFrame: 15 minutes preoperative, 15 minutes postoperative.
measure: Serum sodium level.
timeFrame: 15 minutes preoperative, 15 minutes postoperative.
measure: Serum potassium level.
timeFrame: 15 minutes preoperative, 15 minutes postoperative.
measure: Hemoglobin level.
timeFrame: 15 minutes preoperative, 15 minutes postoperative.
measure: Hematocrit value.
timeFrame: 15 minutes preoperative, 15 minutes postoperative.
Other outcomes:
Locations:
city: Mansourah.
country: Egypt
facility: Oncology Center Mansoura University.
state: Dakahlia
Study officials:
References: