NCT06220734

Brief Summary

Early detection of fluid accumulation in alveolar, interstitial, and intracellular compartments of the lung due to intravascular absorption of irrigation fluid of TURP guided by lung ultrasound by detection of sonographic B lines.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 14, 2024

Last Update Submit

January 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of intraoperative lung congestion quantified by number of sonographic B-lines in anterolateral lung ultrasound scan in patients undergoing TURP

    Early detection of fluid accumulation in alveolar, interstitial, and intracellular compartments of the lung due to intravascular absorption of irrigation fluid of TURP guided by lung ultrasound by detection of sonographic B lines

    1 year

Interventions

transurethral resection of the prostate for indicated patients then US was done for early detection of fluid accumulation in the lungs

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

men attended at assuit university hospital, for underwent transurethral resection of the prostate and fulfilled inclusion criteria

You may qualify if:

  • ASA Class I, II or III adult patients of age group 18-65 years.
  • Patient undergoing TURP.

You may not qualify if:

  • Patients unable to provide written consent.
  • Patients less than 18 years or above 65 years.
  • ASA Class IV.
  • Patients previously diagnosed to suffer from interstitial lung disease.
  • patients who will receive intraoperative diuretics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gravenstein D. Transurethral resection of the prostate (TURP) syndrome: a review of the pathophysiology and management. Anesth Analg. 1997 Feb;84(2):438-46. doi: 10.1097/00000539-199702000-00037. No abstract available.

    PMID: 9024044BACKGROUND
  • Gupta K, Rastogi B, Jain M, Gupta PK, Sharma D. Electrolyte changes: An indirect method to assess irrigation fluid absorption complications during transurethral resection of prostate: A prospective study. Saudi J Anaesth. 2010 Sep;4(3):142-6. doi: 10.4103/1658-354X.71505.

    PMID: 21189849BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

None Retained

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Monica Nabil ELcellini

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

January 14, 2024

First Posted

January 24, 2024

Study Start

April 5, 2024

Primary Completion

April 5, 2025

Study Completion

August 5, 2025

Last Updated

January 24, 2024

Record last verified: 2024-01