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Ultrasound Lung Fluid Responsiveness During Hysterectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03429751
Enrollment
48
Registered
2018-02-12
Start date
2016-07-10
Completion date
2017-09-01
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Overload

Keywords

lung ultrasound, fluid, hysterectomy, B lines

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.

Interventions

DRUG30 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.

DRUG10 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.

Sponsors

Alaa Mazy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
The total volume of blood transfusion.Intraoperative.milliliter
The amount of blood loss.Intraoperative.milliliter, estimated from the weight of swaps and suction bottles.
The duration of surgery.intraoperative.minutes. from the time of induction of anesthesia till extubation time.
Central venous pressureBasal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.centimeter water.
Mean blood pressureBasal 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.
The total volume of crystalloid infusion.Intraoperative.milliliter
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.
Serum sodium level.15 minutes preoperative, 15 minutes postoperative.millimole per liter.
Serum potassium 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.
Peripheral oxygen saturation.Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.percent.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026