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

NCT ID: NCT06079177

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-12-30

Brief Summary

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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

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Conditions

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Transurethral Resection of Prostate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Ultrasound

Intervention Type DEVICE

LUS using B-lines Caval-Aorta index using ultrasound

Interventions

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Ultrasound

LUS using B-lines Caval-Aorta index using ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dalia Saad Abd-El Kader

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dalia Saad

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Dalia Saad, assi prof

Role: CONTACT

01223911524

Abeer Ahmed, professor

Role: CONTACT

Facility Contacts

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Dalia Saad

Role: primary

01223911301

References

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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.

Reference Type BACKGROUND
PMID: 23166168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16469429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24782656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26298866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27051368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28612302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24821071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30664523 (View on PubMed)

Other Identifiers

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MD-295/2022

Identifier Type: -

Identifier Source: org_study_id

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