Topics

Basic Hemodynamic Monitoring Reliability During Percutaneous Nephrolithotomy.

2019-02-07 18:37:16 | BioPortfolio

Summary

This prospective pre and post-quasi-descriptive single group interventional study will be done at urology and nephrology center -Mansoura University during the year 2019, for a 3-month duration, starting 1-2-2019 till 1-4-2019 after approval of IRB (Institutional Review Board) code no R/18.03.103 on 5/5/2018, Mansoura Faculty of Medicine. correlating Basic hemodynamics with noninvasive cardiac output for diagnostic reliability during percutaneous nephrolithotomy hidden bleeding under spinal anesthesia

Description

Hypothesis: On the concept of patient safety, using basic noninvasive monitoring tools (Blood pressure, HR, pulse oximetry O2 Saturation) are late and deceiving and non-reliable hemodynamic measuring tools in diagnosing the progression of the silent hidden bleeding during percutaneous nephrolithotomy surgery (PCNL) operations and necessitate adding noninvasive COP (bioimpedance based) monitor for minute to minute detection of the hemodynamic changes during (PCNL) surgery (necessitates high level spinal anesthesia and prolonged prone position with its hemodynamic burden, carries high risk of inaccessible uncontrollable bleeding).

Aim of the work:

Targeting more intraoperative patient safety by determination of the credibility of basic hemodynamic monitors in reflecting the real cardiopulmonary functions during PCNL operation (high risk hidden bleeding) under prone position spinal anesthesia.

Achieved by using correlation between intraoperative noninvasive thoracic bioimpedance [COP -oxygenation] monitor and the usually used basic intraoperative [hemodynamic-oxygenation] monitoring systems; two outcome categories will be correlated; a)-Circulatory category: thoracic bioimpedance based COP hemodynamic parameters including (cardiac output COP-stroke volume SV -stroke index SI- cardiac index CI-cardiac performance index CPI-stroke volume variability SVV, systemic vascular resistance SVR, systemic vascular resistance index SVRI) correlation with the usual basic hemodynamic monitoring dependent parameters noninvasive blood pressure NIBP (systolic SBP and mean MAP) and the heart rate HR. b)- Oxygenation category: (Oxygen delivery (Do2), Oxygen delivery index (Do2I), Oxygen content (Cao2) correlation with the basic monitor pulse oximeter oxygen saturation (Sao2).

Correlation will be done at 3 times first basal (just after prone position adjustment and before PCNL puncture, after 60 min then after 120 minutes of prone position adjustment.

Patient & Methods:

This prospective pre and post-quasi-descriptive single group interventional study will be done at urology and nephrology center -Mansoura University during the year 2019, for a 3-month duration, starting 1-2-2019 till 1-4-2019 after approval of IRB (Institutional Review Board) code no R/18.03.103 on 5/5/2018, Mansoura Faculty of Medicine.

Sample size calculation Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 15.0.5 for Windows (2017) using results obtained by a pilot study conducted on 5 patients at Mansoura urology and nephrology center (January-2019) with the difference in reliability (as measured by Cronbach's alpha) between mean non-invasive blood pressure (MAP) and stroke volume index (SVI) as the primary outcome. We choose the SVI over other monitoring tools as cardiac output or the cardiac index due to its relatively more available measurement tools. A sample size of 32 patients is needed to achieve 90% power and detect the difference between the Cronbach's alpha of the MAP (considered to be the null hypothesis) of 0.974 and the Cronbach's alpha for the SVI of 0.988 using a two-sided F-test with a significance level of 0.05. The expected number of drop-outs is 8, so a total of 40 patients will be enrolled into the study.

Preparation:

After patient examination and consultation about any comorbidities. A consent will be taken after explanation of the anesthetic procedures, 1000 ml Ringers solution during 30 minutes before aesthesia the morning of the procedure.

Intraoperative management:

After attaching all standard monitors (ECG, NIBP, pulse oximeter) and the COP bio-impedance monitor recording basal data (COP, CI, SV, CPI, CaO2, Do2, DO2I, SVR, SVV.

During sitting position intrathecal anesthesia was conducted in the sitting position under complete aseptic condition using heavy bupivacaine 15mg (3ml) plus 20 mic =0.2ml Fentanyl 25G needle after 2 ml Lidocaine skin infiltration. lithotomy position till anaesthesia level documented T4 and fixed and lower urinary tract endoscopy then shifting the patient to prone position and after adjustment of the prone position precautions 2 bellows one under the chest and one under the pelvis with pliable free moving abdomen jell ring under the patient head knees and in front of heels, then the basal data recording and after that data recording every 10 minutes till end of the operative procedure. Blood sampling at basal, 60 and 120 minutes for HB level detection.

Episodes of perioperative: Hypotension is defined as mean arterial blood pressure (MBP) less than 65 mmHg, will be managed by using bolus doses of ephedrine 6 mg, fluids and blood transfusion according to patients HB level with blood transfusion cut point of 8mg/dl. Bradycardia is defined as HR less than 60 b/m. will be managed by atropine 0.5 mg bolus. Desaturation is defined as SaO2< 90% will be managed by stop surgery, increase O2 flow via the oxygen face mask from 5 to 10 liters/minute, chest auscultation and verbal patient examination with shift to lithotomy position if desaturation persist and keep all tools and drugs ready for intubation and mechanical ventilation if needed. Nausea will be managed by treatment of hypotension as a common cause and propofol 20 mg. vomiting will be treated by dexamethasone 0.1mg/Kg with metoclopramide 0.1mg/Kg.

Intraoperative pain will be managed by fentanyl 0.5 mcg/kg, IV infusion of paracetamol 10mg/kg, propofol 50 mg increments, or general anesthesia using ETT and inhalational maintenance if there is still more than 15 min expected time to end the surgical procedure by shifting to lithotomy position and then General anesthesia induction with endotracheal intubation with mechanical ventilation then continue surgery and the case excluded from the study and replaced as a dropout case.

Primary outcome:

Stroke volume index (SVI)

Secondary outcome:

Hemoglobin (HB) (blood sampling at basal after 1h then after 2 hours), cardiac output (COP)- Stroke volume (SV)- Cardiac performance index (CPI)-systemic vascular resistance (SVR) - systemic vascular resistance index (SVRI) - stroke volume variability (SVV)- Oxygen delivery DOI-cardiac Index-oxygen content (Cao2) - Oxygen delivery (DO2)- Oxygen delivery index (DO2I). Noninvasive Intraoperative hemodynamic (systolic blood pressure (SBP), mean blood pressure (MAP), heart rate (HR) and O2 saturation (SaO2). All mentioned variables will be recorded basal and every 10 minutes till end of surgery.

Statistical analysis

IBM's SPSS statistics (Statistical Package for the Social Sciences) for windows (version 25) will be used for statistical analysis of the collected data. Shapiro-Wilk test will be used to check the normality of the data distribution. Normally distributed continuous variables will be expressed as mean ± SD while categorical variables and the abnormally distributed continuous ones will be expressed as median and inter-quartile range or number and percentage (as appropriate). Reliability analysis will be conducted using Cronbach's alpha test. Student t test and Mann-Whitney will be used for normally and abnormally distributed continuous data respectively. Chi square test will be used for categorical data using the crosstabs function. All tests will be conducted with 95% confidence interval. If needed, bivariate correlations will be assessed using Pearson's or Spearman's correlation coefficient depending on the nature of data. P (probability) value < 0.05 will be considered statistically significant.

Study Design

Conditions

Renal Stone

Intervention

spinal anesthesia monitoring

Status

Not yet recruiting

Source

Mansoura University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-02-07T18:37:16-0500

Clinical Trials [4234 Associated Clinical Trials listed on BioPortfolio]

Shockwave Lithotripsy (SWL) Under Selective, General Anesthesia.

SWL is widely used in the treatment of patients with renal and ureteral calculi. Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: ston...

Continuous Spinal Anesthesia in Renal Transplantation

Renal transplantation is now recognized as a treatment of choice for patients with end-stage renal disease. An adequate anesthetic technique should achieve hemodynamic stability and enhanc...

Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the stu...

Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block

In major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (CSA) and combined spinal epidural anesthesia (CSE) are safe and reliable anaesthesia methods. Our r...

RIRS Versus ESWL for the Treatment of Renal Stones

To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size.

PubMed Articles [8896 Associated PubMed Articles listed on BioPortfolio]

Spinal anesthesia compared with general anesthesia for neonates with hypertrophic pyloric stenosis. A retrospective study.

Studies of spinal anesthesia in children are limited to a reduced group of high-risk patients and it remains relatively underused compared with general anesthesia in this age group in most institution...

Loss of Corneal Reflex in Children Undergoing Spinal Anesthesia: A Case Series.

Spinal anesthesia is administered for select procedures in the pediatric population and offers a safe alternative to general anesthesia. In this case series, we report loss of corneal and eyelash refl...

Application of an Infant Spinal Anesthesia Protocol in Infants Presenting for Inguinal Herniorrhaphy Improves Operating Room and Post Anesthesia Recovery Unit Utilization.

Spinal anesthesia is a safe and beneficial alternative to general anesthesia in infants (1, 2). We would like to share a prospective observational study of infants undergoing inguinal herniorrhaphy un...

Spinal anesthesia for lumbar spine surgery correlates with fewer total medications and less frequent use of vasoactive agents: A single center experience.

Anesthesiologists at our hospital commonly administer spinal anesthesia for routine lumbar spine surgeries. Anecdotal impressions suggested that patients received fewer anesthesia-administered intrave...

Ureteroscopy in patients with spinal cord injury: outcomes from a spinal injury unit and a review of literature.

Spinal cord injury (SCI) patients are at increased risk of developing urolithiasis. Ureteroscopic management for stone disease in SCI patients is underreported. Endourologists face many challenges in ...

Medical and Biotech [MESH] Definitions

A severe pain in the lower back radiating to the groin, scrotum, and labia which is most commonly caused by a kidney stone (RENAL CALCULUS) passing through the URETER or by other urinary track blockage. It is often associated with nausea, vomiting, fever, restlessness, dull pain, frequent urination, and HEMATURIA.

Procedure in which an anesthetic is injected directly into the spinal cord.

The continuous measurement of physiological processes, blood pressure, heart rate, renal output, reflexes, respiration, etc., in a patient or experimental animal; includes pharmacologic monitoring, the measurement of administered drugs or their metabolites in the blood, tissues, or urine.

A local anesthetic of the amide type now generally used for surface anesthesia. It is one of the most potent and toxic of the long-acting local anesthetics and its parenteral use is restricted to spinal anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1006)

Hospital unit providing continuous monitoring of the patient following anesthesia.

More From BioPortfolio on "Basic Hemodynamic Monitoring Reliability During Percutaneous Nephrolithotomy."

Quick Search

Relevant Topics

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Anesthesia
Anesthesia is the loss of feeling or sensation in all or part of the body. It may result from damage to nerves or can be induced by an anesthetist (a medical professional) using anesthetics such as thiopental or propofol or sevoflurane during a surgical ...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...


Searches Linking to this Trial