B-lines Score as Indicator for the Systemic Volumetric Load During TURP

January 13, 2024 updated by: Dalia Saad Abd-El Kader, Kasr El Aini Hospital

B-lines Score Derived From Lung Ultrasonography as a Noninvasive Indicator for the Systemic Volumetric Load During TURP. A Prospective Observational Study.

Lung Ultrasonography score (LUS) using B-lines is a noninvasive, reliable and promising method for determining the extravascular lung water (EVLW). This was previously evaluated by trans-pulmonary thermodilution technique.

The transurethral resection of the prostate syndrome (TURP-S) is a potentially life-threatening complication of the TURP surgery and timely diagnosis of TURP-S is crucial for rapid detection and optimized treatment.

This observational study is designed to investigate the use of LUS using B-lines as a bed-side, simple, and non-invasive indicator for predication of the presence of systemic volume overload in patients undergoing endoscopic TURP.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Dalia Saad
        • Contact:
          • Dalia Saad
          • Phone Number: 01223911301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male patients with age ≥ 60 years undergoing TURP surgery

Description

Inclusion Criteria:

  • Age ≥ 60 years.
  • American Society of Anesthesiologists Classification (ASA ) I, II, and III.
  • Full conscious patients.

Exclusion Criteria:

  • Patient refusal.
  • Who known allergic or hypersensitivity to any drug used in the study (local anesthesia).
  • Coagulopathy (history of bleeding disorders), or patients on anticoagulant drugs, with (platelets <50,000 International Normalised Ratio( INR)>1.5).
  • Patients have renal dysfunction patients with creatinine ≥ 2.
  • Patients have uncontrolled cardiac diseases (IHD, (congestive heart failure (CHF), pulmonary hypertension and valvular diseases).
  • Abdominal ascites.
  • Patients with local infection at the site of local anesthetic injection.
  • Failed spinal anesthesia.
  • Timing not exceed 90 min.
  • Any patient with lung ultrasound examination at T 0 ≥ 3 B-lines will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male patients with age ≥ 60 years undergoing TURP surgery

All patients will receive spinal anesthesia Under complete aseptic technique at level of L 4-L5 or L3-L4 using 12.5-15 mg of 0.5 % hyperbaric bupivacaine and 25 ug fentanyl.

Lung ultrasound score:

A curvilinear (5-2 MHz) probe will be used. The sliding multiple B-lines will be evaluated in eight antero-lateral lung examination zones.

Inferior vena cava (IVC) measurement using ultrasound:

A curvilinear (5-2 MHz) probe with B-mode scan will be used. Caval-Aorta index will be calculated by taking the ratio of the two respective diameters measured.

Other vital parameter as ,heart rate (HR), Mean arterial pressure (MAP), oxygen saturation (SpO2), arterial blood gases (ABG), serum Na and K levels will be measured and recorded at same time as the following:

(T0) ,(T1) ,(T2),(T3) ,(T30, T60, T90) intraoperative ,(T PACU),(T critical)
Device: Ultrasound
LUS using B-lines Caval-Aorta index using ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive ability of the LUS using B-lines for the presence of systemic volume overload in patients undergoing endoscopic TURP
Time Frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
using ultrasound
From the preoperative period (T0) to 60 Minutes postoperative (T PACU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive ability of the Caval-Aorta index as predictors of systemic volume overload in patients undergoing endoscopic TURP.
Time Frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
using ultrasound
From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Correlation between the absolute value of LUS, Caval-Aorta index .
Time Frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
using ultrasound
From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Correlation between the relative changes of the LUS and Caval-Aorta index
Time Frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
using ultrasound
From the preoperative period (T0) to 60 Minutes postoperative (T PACU)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MD-295/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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