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

NCT06079177 | Unknown DMC

• 1 other identifier: MD-295/2022
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Transurethral Resection of Prostate

Keywords

Lung Ultrasonography score (LUS); extravascular lung water (EVLW); Transurethral resection of the prostate (TURP)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• Correlation between the absolute value of LUS, Caval-Aorta index .

  From the preoperative period (T0) to 60 Minutes postoperative (T PACU)

• Correlation between the relative changes of the LUS and Caval-Aorta index

  From the preoperative period (T0) to 60 Minutes postoperative (T PACU)

Study Arms (1)

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

Interventions

Ultrasound DEVICE

LUS using B-lines Caval-Aorta index using ultrasound

Male patients with age ≥ 60 years undergoing TURP surgery

Eligibility Criteria

• Age: 60 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients with age ≥ 60 years undergoing TURP surgery

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Dalia Saad

Cairo, Egypt

Location

Related Publications (8)

• 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.

  PMID: 23166168 BACKGROUND

• 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.

  PMID: 16469429 BACKGROUND

• 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.

  PMID: 24782656 BACKGROUND

• 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.

  PMID: 26298866 BACKGROUND

• 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.

  PMID: 27051368 BACKGROUND

• 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.

  PMID: 28612302 BACKGROUND

• 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.

  PMID: 24821071 BACKGROUND

• 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.

  PMID: 30664523 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Dalia Saad, assi prof

CONTACT

01223911524; dalia_saad@kasralainy.edu.eg

Abeer Ahmed, professor

CONTACT

abeer_ahmed@kasralainy.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 12, 2023
• Study Start: March 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)