Evaluation of echocardiographic indices to predict how infants less than 28 days respond to intravenous fluid bolus in peri-operative period

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/01/039217
• Lead Sponsor: Department of Anaesthesia and Intensive Care

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-16
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory variations in peak velocity of aortic blood flow	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Mani Kiran

Principal investigator

9885202360

dimond1989@gmail.com