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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2014/12/005336
Date of registration: 30-12-2014
Prospective Registration: No
Primary sponsor: Manipal University
Public title: Respiratory variation in two blood flow parameters in anaesthetised and ventilated children
Scientific title: Respiratory variation in aortic flow peak velocity and inferior vena cava diameter as indicator of fluid responsiveness in mechanically ventilated children- A cross sectional study.
Date of first enrolment: 13-12-2011
Target sample size: 42
Recruitment status: Completed
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7898
Study type:  Interventional
Study design:  Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
 
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Dr Sagar M S   
Address:  Door No: 3342 MCC B Block 4th cross, 15th Main Davangere Department of Anaesthesiology Kasturba Medical College, Manpal Manipal University 576104 Mumbai, KARNATAKA India
Telephone: 9972825621
Email: drshreepathi@gmail.com
Affiliation:  Kasturba Medical College
Name: Dr Shreepathi K Achar   
Address:  Department of Anaesthesiology Kasturba Medical College, Manipal Manipal University 576104 Udupi, KARNATAKA India
Telephone: 9972825621
Email: drshreepathi@gmail.com
Affiliation:  Kasturba Medical College
Key inclusion & exclusion criteria
Inclusion criteria: healthy children posted for elective surgical procedures under general anaesthesia were chosen.
Exclusion criteria: Children with congenital or acquired heart diseases and cardiac arrhythmias

Children suffering from pulmonary and renal diseases

Children presenting with mass in the abdomen/raised intra-abdominal pressure



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Health Condition 1: null- Helathy children posted for planned surgery
Intervention(s)
Intervention1: Fluid Challenge: 10 ml/kg of crystalloid was administered
Intervention2: Fluid challenge: Study parameters are measured in patient before fluid challenge ,and the same measurements repeated again after the intervention i.e fluid challenge. The change in the parameters will be later calculated and compared with a standard method.
Control Intervention1: Two study parameters measured after fluid challenge: Study parameters are measured again after fluid challenge in the same group
Primary Outcome(s)
Respiratory variation in aortic flow peak velocity and inferior vena cava (IVC) diameter as predictors of fluid responsiveness

Timepoint: Intraoperative period
Secondary Outcome(s)
Effect of fluid challenge on fasting status

Timepoint: Intraoperative period
Secondary ID(s)
NIL
Source(s) of Monetary Support
Kasturba Hospital, Manipal
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 13/12/2011
Contact:
Kasturba Medical College Institutional Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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