ASSESSMENT OF FLOW-BASED DYNAMIC INDICES TO PREDICT FLUID RESPONSIVENESS IN NEONATES
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Respiratory variations in peak velocity of aortic blood flow
Study Overview
Brief Summary
Administration of intravenous fluid boluses is a common intervention to treat perioperative hypotension. But, fluid administration may not always correct hypotension. Excessive intravenous fluid has many adverse affects. In quest of objective parameters to predict fluid responsiveness, static parameters like heart rate, blood pressure, central venous pressure and others failed to serve this purpose. Dynamic parameters, which are based on heart lung interaction are found to be useful in predicting fluid responsiveness in adults. Neonates physiology is different from adult population. So, we plan to conduct a study to validate the dynamic parameters viz. respiratory variation in aortic outflow, respiratory variation in velocity time integral of aortic flow and plethysmography variability index to predict fluid responsiveness in neonates undergoing procedures under general anaesthesia.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Late preterm (>34 weeks of gestational age) and term neonates upto 28 days of age scheduled for elective or emergency non-thoracic and non-cardiac surgeries.
Exclusion Criteria
- •Congenital heart disease Cardiac arrhythmias Neonates on inotropic and/ or vasoactive support Pneumonia/ Atelectasis Denial to participate in the study.
Outcomes
Primary Outcomes
Respiratory variations in peak velocity of aortic blood flow
Time Frame: 1. Baseline immediately after induction of anaesthesia. As a standard of care, an i.v. bolus of 10 ml/kg Ringers Lactate will be administered over 10 minutes after taking baseline measurement. | 2. Second measurement will be done 2 minutes after end of i.v. fluid bolus
Secondary Outcomes
- Respiratory variations in velocity time integral of aortic blood flow and plethysmographic variablility index(1. Baseline immediately after induction of anaesthesia. As a standard of care, an i.v. bolus of 10 ml/kg Ringers Lactate will be administered over 10 minutes after baseline measurements.)