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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03155555
Other study ID # NK/3046/MD/400
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2016
Est. completion date December 17, 2017

Study information

Verified date April 2019
Source Postgraduate Institute of Medical Education and Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 17, 2017
Est. primary completion date December 17, 2017
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
India Postgraduate Institute of Medical Education & Research Chandigarh

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Correlation between aortic peak systolic velocity variation measured from apical and suprasternal windows Correlation between aortic peak systolic velocity variation measured from apical and suprasternal windows by Bland-Altman analysis Measurements made within 3 minutes
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