Transurethral Resection of ProstateNCT06079177
B-lines Score as Indicator for the Systemic Volumetric Load During TURP
An observational study of Transurethral Resection of Prostate, run by Kasr El Aini Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 60 to 90 years, men only
- Conditions the study is for
- Transurethral Resection of Prostate
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with age ≥ 60 years undergoing TURP surgery
Who may be able to join
- Age ≥ 60 years.
- American Society of Anesthesiologists Classification (ASA ) I, II, and III.
- Full conscious patients.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Abeer Ahmed, professor contact
About this study
Official title: B-lines Score Derived From Lung Ultrasonography as a Noninvasive Indicator for the Systemic Volumetric Load During TURP. A Prospective Observational Study.
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
- Being tested
- Ultrasound
- Keywords
- Lung Ultrasonography score (LUS), extravascular lung water (EVLW), Transurethral resection of the prostate (TURP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
LUS using B-lines Caval-Aorta index using ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive ability of the LUS using B-lines for the presence of systemic volume overload in patients undergoing endoscopic TURP
using ultrasound
Measured: 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.
using ultrasound
Measured: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Correlation between the absolute value of LUS, Caval-Aorta index .
using ultrasound
Measured: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Correlation between the relative changes of the LUS and Caval-Aorta index
using ultrasound
Measured: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Mar 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Transurethral Resection of ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Saad Abd-El Kader, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079177
- Sponsor's protocol ID
- MD-295/2022
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23166168Rassweiler 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.
PubMed 16469429Nakahira 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.
PubMed 24782656Zhao 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.
PubMed 26298866El-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.
PubMed 27051368Anile 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.
PubMed 28612302Volpicelli 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.
PubMed 24821071Salama 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.
PubMed 30664523
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-lines Score Derived From Lung Ultrasonography as a Noninvasive Indicator for the Systemic Volumetric Load During TURP. A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06079177
- Acronym / sponsor ID
- MD-295/2022
- Conditions
- Transurethral Resection of Prostate
- Keywords
- Lung Ultrasonography score (LUS), extravascular lung water (EVLW), Transurethral resection of the prostate (TURP)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male patients with age ≥ 60 years undergoing TURP surgery | – | Device: UltrasoundAll 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) |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with age ≥ 60 years undergoing TURP surgery
Key inclusion criteria (3 listed)
- Age ≥ 60 years.
- American Society of Anesthesiologists Classification (ASA ) I, II, and III.
- Full conscious patients.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundLUS using B-lines Caval-Aorta index using ultrasound | Device | Male patients with age ≥ 60 years undergoing TURP surgery |
Primary outcome
Predictive ability of the LUS using B-lines for the presence of systemic volume overload in patients undergoing endoscopic TURP
Time frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
using ultrasound
3 secondary outcomes
Predictive ability of the Caval-Aorta index as predictors of systemic volume overload in patients undergoing endoscopic TURP.
Time frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Correlation between the absolute value of LUS, Caval-Aorta index .
Time frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Correlation between the relative changes of the LUS and Caval-Aorta index
Time frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 23166168Demirel 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.
- Background: PubMed 16469429Rassweiler 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.
- Background: PubMed 24782656Nakahira 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.
- Background: PubMed 26298866Zhao 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.
- Background: PubMed 27051368El-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.
- Background: PubMed 28612302Anile 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.
- Background: PubMed 24821071Volpicelli 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.
- Background: PubMed 30664523Salama 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer Ahmed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transurethral Resection of Prostate, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Saad, assi prof (01223911524, dalia_saad@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive ability of the LUS using B-lines for the presence of systemic volume overload in patients undergoing endoscopic TURP (time frame: From the preoperative period (T0) to 60 Minutes postoperative (T PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06079177, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024; AzTrials last refreshed its copy on 29 Oct 2026.