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

Not yet recruiting

• Conditions: Transurethral Resection of Prostate

• Registration Number: NCT06079177
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-13
• Last Update Posted: 2024-01-17
• Study Start: 2024-03-01
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dalia Saad; 🇪🇬 Cairo, Egypt