Anesthesia, GeneralNCT03155555
Comparison of Carotid Peak Systolic Velocity Variation With Aortic Peak Systolic Velocity Variation in Pediatric Non-Cardiac Surgery
An observational study of Anesthesia, General and Anesthesia, Endotracheal, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Anesthesia, General, Anesthesia, Endotracheal, Mechanical Ventilation
- What is being tested?
- Measurement of aortic and carotid Doppler peak systolic velocity variation
- How many people
- 52 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2016to 17 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Eligible patients consenting for inclusion
Who may be able to join
- Patients scheduled for mon-cardiac surgeries under general endotracheal anaesthesia in supine position with expected duration more than 1 hour
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012
About this study
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
- Being tested
- Measurement of aortic and carotid Doppler peak systolic velocity variation
- Keywords
- Fluid Responsiveness, Pediatric surgery, General endotracheal anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of aortic and carotid Doppler peak systolic velocity variationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Children aged 1-12 years undergoing major surgeries under general endotracheal anaesthesia with mechanical ventilation under neuromuscular blockade Receives: Other: Measurement of aortic and carotid Doppler peak systolic velocity variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measurements made within 3 minutes
Secondary outcomes (1)
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
Measured: Measurements made within 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startDec 2016
- Primary completion17 Dec 2017
- Study completion17 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Subhrashis Guha Niyogi, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Subhrashis Guha Niyogi, MBBS, Principal investigator, Junior Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155555
- Sponsor's protocol ID
- NK/3046/MD/400
- Status last verified
- Apr 2019
- First submitted
- 14 May 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31811550
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Carotid Peak Systolic Velocity Variation With Aortic Peak Systolic Velocity Variation in Pediatric Non-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03155555
- Acronym / sponsor ID
- NK/3046/MD/400
- Conditions
- Anesthesia, General, Anesthesia, Endotracheal, Mechanical Ventilation, Fluid Responsiveness
- Keywords
- Fluid Responsiveness, Pediatric surgery, General endotracheal anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 17 Dec 2017 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Measurement of aortic and carotid Doppler peak systolic velocity variationChildren aged 1-12 years undergoing major surgeries under general endotracheal anaesthesia with mechanical ventilation under neuromuscular blockade |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Eligible patients consenting for inclusion
Key inclusion criteria (1 listed)
- Patients scheduled for mon-cardiac surgeries under general endotracheal anaesthesia in supine position with expected duration more than 1 hour
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of aortic and carotid Doppler peak systolic velocity variationAortic 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. | Other | Experimental |
Primary outcome
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
1 secondary outcome
Correlation between aortic peak systolic velocity variation measured from apical and suprasternal windows
Time frame: Measurements made within 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 31811550Niyogi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhrashis Guha Niyogi, MBBS principal investigator
Junior Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General and Anesthesia, Endotracheal, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of carotid peak systolic velocity variation with aortic peak systolic velocity variation (time frame: Measurements made within 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03155555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.