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

April 12, 2019 updated by: Dr. Subhrashis Guha Niyogi, Postgraduate Institute of Medical Education and Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education & Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible patients consenting for inclusion

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of carotid peak systolic velocity variation with aortic peak systolic velocity variation
Time Frame: Measurements made within 3 minutes
Comparison of carotid peak systolic velocity variation with aortic peak systolic velocity variation by Bland-Altman analysis
Measurements made within 3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between aortic peak systolic velocity variation measured from apical and suprasternal windows
Time Frame: Measurements made within 3 minutes
Correlation between aortic peak systolic velocity variation measured from apical and suprasternal windows by Bland-Altman analysis
Measurements made within 3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Subhrashis Guha Niyogi, MBBS, Junior resident

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 17, 2017

Study Completion (Actual)

December 17, 2017

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK/3046/MD/400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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