Basic Hemodynamics in Correlation With Noninvasive Cardiac Output: A Diagnostic Reliability Issue During Percutaneous Nephrolithotomy Bleeding Under Spinal Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Stroke volume index (SVI)
Study Overview
Brief 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
Detailed 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).
The 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 is 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), 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled for percutaneous nephrolithotomy endoscopic operation
- •Both sexes,
- •Age 18 - 70 years.
- •PCNL operation time ≥120 minutes.
Exclusion Criteria
- •Patient refusal.
- •PCNL operation time <120 minutes.
- •Hypersensitivity to amide local anesthetics.
- •General contraindications to spinal anesthesia, coagulopathy.
- •Cardiac, hepatic, renal or respiratory failure.
- •Difficult communication.
Arms & Interventions
cop variables
non invasive cop vsriables correlation to basic monitoring variables during prone position spinal anesthesia intervention pcnl operation at basic ,1hour and 2hours .
Intervention: spinal anesthesia monitoring (Procedure)
Outcomes
Primary Outcomes
Stroke volume index (SVI)
Time Frame: up to 120 minutes.
continuous stroke volume index (stroke volume divided by the body weight) during prone position spinal anesthesia
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Abd Latif Ghanim
Associate Professor os anesthesia ICU & Pain medicine.
Mansoura University