Ultrasound Assessment of Extravascular Lung Water in Patients Undergoing Percutaneous Nephrolithotomy

Percutaneous Nephrolithotomy Clinical Trial

Official title:

Ultrasound Assessment of Irrigation Fluid Effect on Extravascular Lung Water in Patients Undergoing Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06141746
• Other study ID #: Extravascular lung water
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Hala A Hashem
• Phone: 01145502643
• Email: Halahashem797[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study protocol:

Anesthetic technique:- After adequate pre-oxygenation for 3-5 min, General anesthesia will be induced by intravenous lidocaine 60 mg, propofol (2mg/kg) and cis-atracurium (0.15 mg/ kg) to facilitate endotracheal intubation by a cuffed endotracheal tube (size 6.5-7.5-mm), then the patient will be connected to mechanical ventilation which will be maintained with an 8 ml/ kg tidal volume, and ventilation frequency well be adjusted to maintain end-tidal CO2 between 30-35 mmHg. Anesthesia will be maintained with isoflurane (0.8-1.0%) in a mixture of oxygen and air (50:50%) and cis-atracurium (0.03 mg/ kg) and maintained every 20 min. Standard monitoring will be used intraoperatively including non-invasive arterial blood pressure, electrocardiography, end-tidal CO2, peripheral oxygen saturation and esophageal core temperature. Patients will receive one liter of normal saline infused over the first 2 hours intraoperatively as their fasting requirements and will be infused with 3 ml/kg/hour of Ringer's acetate as a maintenance fluid. Intraoperative hypotension (more than 20% decrease of the baseline of the patient ) will be treated by a bolus dose of crystalloid (4 ml/kg) as well as a bolus dose of ephedrine (3 mg). Atropine (0.5 mg) will be used to treat bradycardia if the heart rate is <60 beat/min. At end of surgery, isoflurane will be discontinued, and neuromuscular block will be antagonized using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), intravenous paracetamol will be given as analgesia and boluses of fentanil Intraoperative as needed . Extubation will performed when patients began breathing spontaneously and were able to respond to verbal requests and discharge to post-Anesthesia Care Unit (PACU) but if the patient is not fulfilling criteria of extubation so discharge will be to Intensive care unit (ICU). If acute Postoperative lung congestion occurs with postoperative hypoxemia and desaturation, it will be treated with furosemide.

Blood samples will be collected for CBC, ABG and electrolytes as sodium and potassium Pre-operative, intraoperative and Immediately Post-operative.

Lung ultrasound scan technique: -

Each patient will be assessed for the presence of B-lines before induction of anesthesia and after end of anesthesia. A curved 2-6-MHz probe of Mindray machine will be used to do a series of scans with the patient in the supine position by applying the probe perpendicular to the skin over intercostal spaces along anatomical reference lines. More precisely, we will scan the anterolateral hemithoraxes along the parasternal, midclavicular, anterior axillary and mid-axillary lines. The left hemithorax will be scanned from the second to the fourth intercostal space, whereas the right lung will be scanned from the second to the fifth intercostal space, giving a total of 28 scanning sites. The edematous lung shows B-lines as vertical narrow bands originating from the pleural line and extending to the bottom of the image. A B-line score of ≤5 will be considered a normal sonographic pattern, since a few B-lines can be present in healthy subjects, especially above the diaphragm.

Data collection:- Patient characteristics

• Age

• Sex

• Medical disease

• Drug intake Operative data

• Mean arterial blood pressure (MAP), heart rate and peripheral oxygen saturation during the following times (before induction of anesthesia, every 15 minutes after intubation, and at the end of surgery)

• Intraoperative complication and interventions.

• Duration of surgery

• Duration of anesthesia

• Type, volume and height of irrigation fluid.

• Ultrasound guided extravascular lung water.

Postoperative data

• Hemoglobin assessment.

• Serum sodium level.

• Serum potassium level.

• Arterial blood gases (ABG).

• Ultrasound guided extravascular lung water.

Statistical analysis:-

●Descriptive analysis Statistical analysis will be carried out by the SPSS statistical software package version 26.0 (IBM/SPSS, Inc., Chicago, IL). Baseline characteristics will be defined using descriptive statistics. Categorical variables were stated as an absolute number (n) and a relative frequency (%), and continuous variables will be represented as a median (interquartile range) or as a mean (± SD), depending on the normality of the distribution. The normality of distribution will be tested by the one-sample Kolmogorov-Smirnov test.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• •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

Related Conditions & MeSH terms

• Extravascular Lung Water
• Percutaneous Nephrolithotomy

Intervention

Device:
• Lung ultrasound
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (13)

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. — View Citation

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. — View Citation

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. Erratum In: Eur Urol. 2016 Apr;69(4):e85. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediately Post-operative and after 24hours postoperative hemoglobin assessment.	Immediately Post-operative and after 24hours postoperative hemoglobin assessment.	1 hour postoperative
Secondary	Immediately Post-operative and after 24hours postoperative serum sodium and potassium assessment.	Immediately Post-operative and after 24hours postoperative serum sodium and potassium assessment.	1 hour postoperative
Secondary	Immediately Post-operative and after 24hours postoperative arterial blood gases (ABG) assessment.	Immediately Post-operative and after 24hours postoperative arterial blood gases (ABG) assessment.	1 hour postoperative