Comparison of Carotid Peak Systolic Velocity Variation With Aortic Peak Systolic Velocity Variation in Pediatric Non-Cardiac Surgery

NCT03155555 | Completed

• 1 other identifier: NK/3046/MD/400
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether carotid Doppler peak systolic velocity can be an easy to measure possible surrogate for echocardiographic measurement of aortic peak systolic velocity variation which is an index of fluid responsiveness in mechanically ventilated children intra-operatively.

Conditions

Anesthesia, General; Anesthesia, Endotracheal; Mechanical Ventilation; Fluid Responsiveness

Keywords

Fluid Responsiveness; Pediatric surgery; General endotracheal anaesthesia

Outcome Measures

Primary Outcomes (1)

• Comparison of carotid peak systolic velocity variation with aortic peak systolic velocity variation

  Comparison of carotid peak systolic velocity variation with aortic peak systolic velocity variation by Bland-Altman analysis

  Measurements made within 3 minutes

Secondary Outcomes (1)

• Correlation between aortic peak systolic velocity variation measured from apical and suprasternal windows

  Measurements made within 3 minutes

Study Arms (1)

Experimental

Children aged 1-12 years undergoing major surgeries under general endotracheal anaesthesia with mechanical ventilation under neuromuscular blockade

Other: Measurement of aortic and carotid Doppler peak systolic velocity variation

Interventions

Measurement of aortic and carotid Doppler peak systolic velocity variation OTHER

Aortic peak systolic velocity variation to be measured by echocardiography from apical five chamber and suprasternal windows alongwith carotid peak systolic velocity variation by Doppler ultrasound simultaneously at intermittent time points intermittently.

Experimental

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients consenting for inclusion

You may qualify if:

• Patients scheduled for mon-cardiac surgeries under general endotracheal anaesthesia in supine position with expected duration more than 1 hour

You may not qualify if:

• Known congenital heart disease
• Any non-sinus rhythm, arrhythmias
• Patients on vasoactive medications
• Chest wall deformities, situs non solitus (eg. dextrocardia)
• Patients scheduled for open chest surgeries
• History of neck surgery/ carotid interventions

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education & Research

Chandigarh, 160012, India

Location

Related Publications (1)

• Niyogi SG, Sen IM, Jayant A, Mandal B, Bhardwaj N, Yaddanapudi S, Mathew P. Surrogate indices of aortic peak systolic velocity variation to monitor fluid responsiveness in pediatric non-cardiac surgery: a prospective observational study. J Clin Monit Comput. 2020 Dec;34(6):1159-1166. doi: 10.1007/s10877-019-00431-8. Epub 2019 Dec 7.

  PMID: 31811550 DERIVED

Study Officials

• Subhrashis Guha Niyogi, MBBS

  Junior Resident

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident, Department of Anaesthesia and Intensive care

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 16, 2017
• Study Start: December 1, 2016
• Primary Completion: December 17, 2017
• Study Completion: December 17, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)