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

Transurethral Resection of Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079177
• Other study ID #: MD-295/2022
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Kasr El Aini Hospital
• Contact: Dalia Saad, assi prof
• Phone: 01223911524
• Email: dalia_saad[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transurethral Resection of Prostate

Intervention

Device:
• Ultrasound
LUS using B-lines Caval-Aorta index using ultrasound

Locations

Country	Name	City	State
Egypt	Dalia Saad	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Anile A, Russo J, Castiglione G, Volpicelli G. A simplified lung ultrasound approach to detect increased extravascular lung water in critically ill patients. Crit Ultrasound J. 2017 Dec;9(1):13. doi: 10.1186/s13089-017-0068-x. Epub 2017 Jun 13. — View Citation

Demirel I, Ozer AB, Bayar MK, Erhan OL. TURP syndrome and severe hyponatremia under general anaesthesia. BMJ Case Rep. 2012 Nov 19;2012:bcr-2012-006899. doi: 10.1136/bcr-2012-006899. — View Citation

El-Baradey GF, El-Shmaa NS. Does caval aorta index correlate with central venous pressure in intravascular volume assessment in patients undergoing endoscopic transuretheral resection of prostate? Saudi J Anaesth. 2016 Apr-Jun;10(2):174-8. doi: 10.4103/1658-354X.168062. — View Citation

Nakahira J, Sawai T, Fujiwara A, Minami T. Transurethral resection syndrome in elderly patients: a retrospective observational study. BMC Anesthesiol. 2014 Apr 23;14:30. doi: 10.1186/1471-2253-14-30. eCollection 2014. — View Citation

Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention. Eur Urol. 2006 Nov;50(5):969-79; discussion 980. doi: 10.1016/j.eururo.2005.12.042. Epub 2006 Jan 30. — View Citation

Salama ER, Elkashlan M. Pre-operative ultrasonographic evaluation of inferior vena cava collapsibility index and caval aorta index as new predictors for hypotension after induction of spinal anaesthesia: A prospective observational study. Eur J Anaesthesiol. 2019 Apr;36(4):297-302. doi: 10.1097/EJA.0000000000000956. Erratum In: Eur J Anaesthesiol. 2019 Nov;36(11):888. — View Citation

Volpicelli G, Skurzak S, Boero E, Carpinteri G, Tengattini M, Stefanone V, Luberto L, Anile A, Cerutti E, Radeschi G, Frascisco MF. Lung ultrasound predicts well extravascular lung water but is of limited usefulness in the prediction of wedge pressure. Anesthesiology. 2014 Aug;121(2):320-7. doi: 10.1097/ALN.0000000000000300. — View Citation

Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive ability of the LUS using B-lines for the presence of systemic volume overload in patients undergoing endoscopic TURP	using ultrasound	From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Secondary	Predictive ability of the Caval-Aorta index as predictors of systemic volume overload in patients undergoing endoscopic TURP.	using ultrasound	From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Secondary	Correlation between the absolute value of LUS, Caval-Aorta index .	using ultrasound	From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Secondary	Correlation between the relative changes of the LUS and Caval-Aorta index	using ultrasound	From the preoperative period (T0) to 60 Minutes postoperative (T PACU)