Clinical trial NCT06079177: B-lines Score as Indicator for the Systemic Volumetric Load During TURP
Official title: B-lines Score Derived From Lung Ultrasonography as a Noninvasive Indicator for the Systemic Volumetric Load During TURP. A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transurethral Resection of Prostate
Keywords: Lung Ultrasonography score (LUS)
extravascular lung water (EVLW)
Transurethral resection of the prostate (TURP)
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 125
Sex: MALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with age ≥ 60 years undergoing TURP surgery

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Predictive ability of the LUS using B-lines for the presence of systemic volume overload in patients undergoing endoscopic TURP
timeFrame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Secondary outcomes:
measure: Predictive ability of the Caval-Aorta index as predictors of systemic volume overload in patients undergoing endoscopic TURP.
timeFrame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
measure: Correlation between the absolute value of LUS, Caval-Aorta index .
timeFrame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
measure: Correlation between the relative changes of the LUS and Caval-Aorta index
timeFrame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dalia Saad
Study officials:
References:
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.
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.
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.
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.
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.
citation: 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.
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.
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.