NCT06141746

Brief Summary

Early detection of fluid accumulation in alveolar, interstitial and intracellular compartments of the lung due to intravascular absorption of irrigation fluid of PNL 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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

October 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

October 20, 2023

Last Update Submit

April 14, 2024

Conditions

Extravascular Lung WaterPercutaneous Nephrolithotomy

Outcome Measures

Primary Outcomes (1)

  • Lung congestion

    Incidence of Post-operative lung congestion quantified by number of sonographic B-lines in anterolateral lung ultrasound scan in patients undergoing percutaneous nephrolithotomy.

    1 hour postoperative

Secondary Outcomes (3)

  • Immediately Post-operative and after 24hours postoperative hemoglobin assessment.

    1 hour postoperative

  • Immediately Post-operative and after 24hours postoperative serum sodium and potassium assessment.

    1 hour postoperative

  • Immediately Post-operative and after 24hours postoperative arterial blood gases (ABG) assessment.

    1 hour postoperative

Interventions

Lung ultrasoundDEVICE

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be carried on patients who are undergoing percutaneous nephrolithotomy under general anesthesia between Nov.2023 and Nov.2024.

You may qualify if:

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

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 (13)

  • Romero V, Akpinar H, Assimos DG. Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Rev Urol. 2010 Spring;12(2-3):e86-96.

    PMID: 20811557BACKGROUND

  • De S, Autorino R, Kim FJ, Zargar H, Laydner H, Balsamo R, Torricelli FC, Di Palma C, Molina WR, Monga M, De Sio M. Percutaneous nephrolithotomy versus retrograde intrarenal surgery: a systematic review and meta-analysis. Eur Urol. 2015 Jan;67(1):125-137. doi: 10.1016/j.eururo.2014.07.003. Epub 2014 Jul 23.

    PMID: 25064687BACKGROUND

  • Rozentsveig V, Neulander EZ, Roussabrov E, Schwartz A, Lismer L, Gurevich B, Klein Y, Weksler N. Anesthetic considerations during percutaneous nephrolithotomy. J Clin Anesth. 2007 Aug;19(5):351-5. doi: 10.1016/j.jclinane.2007.02.010.

    PMID: 17869985BACKGROUND

  • Gehring H, Nahm W, Zimmermann K, Fornara P, Ocklitz E, Schmucker P. Irrigating fluid absorption during percutaneous nephrolithotripsy. Acta Anaesthesiol Scand. 1999 Mar;43(3):316-21. doi: 10.1034/j.1399-6576.1999.430312.x.

    PMID: 10081538BACKGROUND

  • Kukreja RA, Desai MR, Sabnis RB, Patel SH. Fluid absorption during percutaneous nephrolithotomy: does it matter? J Endourol. 2002 May;16(4):221-4. doi: 10.1089/089277902753752160.

    PMID: 12042103BACKGROUND

  • Atici S, Zeren S, Aribogan A. Hormonal and hemodynamic changes during percutaneous nephrolithotomy. Int Urol Nephrol. 2001;32(3):311-4. doi: 10.1023/a:1017527126481.

    PMID: 11583340BACKGROUND

  • Koroglu A, Togal T, Cicek M, Kilic S, Ayas A, Ersoy MO. The effects of irrigation fluid volume and irrigation time on fluid electrolyte balance and hemodynamics in percutaneous nephrolithotripsy. Int Urol Nephrol. 2003;35(1):1-6. doi: 10.1023/a:1025956810783.

    PMID: 14620272BACKGROUND

  • Mohta M, Bhagchandani T, Tyagi A, Pendse M, Sethi AK. Haemodynamic, electrolyte and metabolic changes during percutaneous nephrolithotomy. Int Urol Nephrol. 2008;40(2):477-82. doi: 10.1007/s11255-006-9093-6.

    PMID: 17318347BACKGROUND

  • Cordts PR, LaMorte WW, Fisher JB, DelGuercio C, Niehoff J, Pivacek LE, Dennis RC, Siebens H, Georgio A, Valeri CR, et al. Poor predictive value of hematocrit and hemodynamic parameters for erythrocyte deficits after extensive elective vascular operations. Surg Gynecol Obstet. 1992 Sep;175(3):243-8.

    PMID: 1514159BACKGROUND

  • Grathwohl KW, Bruns BJ, LeBrun CJ, Ohno AK, Dillard TA, Cushner HM. Does hemodilution exist? Effects of saline infusion on hematologic parameters in euvolemic subjects. South Med J. 1996 Jan;89(1):51-5. doi: 10.1097/00007611-199601000-00008.

    PMID: 8545692BACKGROUND

  • Guzelburc V, Balasar M, Colakogullari M, Guven S, Kandemir A, Ozturk A, Karaaslan P, Erkurt B, Albayrak S. Comparison of absorbed irrigation fluid volumes during retrograde intrarenal surgery and percutaneous nephrolithotomy for the treatment of kidney stones larger than 2 cm. Springerplus. 2016 Oct 4;5(1):1707. doi: 10.1186/s40064-016-3383-y. eCollection 2016.

    PMID: 27757377BACKGROUND

  • Wang CH, Chen NC, Tsai MS, Yu PH, Wang AY, Chang WT, Huang CH, Chen WJ. Therapeutic Hypothermia and the Risk of Hemorrhage: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicine (Baltimore). 2015 Nov;94(47):e2152. doi: 10.1097/MD.0000000000002152.

    PMID: 26632746BACKGROUND

  • Shin HJ, Na HS, Jeon YT, Park HP, Nam SW, Hwang JW. The impact of irrigating fluid absorption on blood coagulation in patients undergoing transurethral resection of the prostate: A prospective observational study using rotational thromboelastometry. Medicine (Baltimore). 2017 Jan;96(2):e5468. doi: 10.1097/MD.0000000000005468.

    PMID: 28079789BACKGROUND

Study Officials

  • Essam Ezzat

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Hala A Hashem

CONTACT

01145502643Halahashem797@gmail.com

Ibrahim Mohamed

CONTACT

01142429670Dr.ibraheemembaby@gmail.com

Study Design

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

Study Record Dates

First Submitted

October 20, 2023

First Posted

November 21, 2023

Study Start

April 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04