- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573842
Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Intra operative hypotension is a risk factor in pediatric anesthesia (McCann ME et al.Pediatr Anesth 2014; 24: 68-73). Bedside ultrasonic assessment of the inferior vena cava (IVC) and IVC collapsibility index (IVCCI) has been shown to indicate fluid status in both adults and children breathing spontaneously (Marcell Szabó et al. BMC Anesthesiol. 2019; 19: 139., Lei Chen et al.Acad Emerg Med. 2007 Oct;14(10):841-5.). Ultrasound assessment of subclavian vein/axillary vein collapsibility has recently been shown to predict hypotension after induction of general anesthesia in adults (Min Hee Choi et al. Eur J Anaesthesiol 2020; 37:474-481). The inverstigators hypothesized that subclavian vein (SCV) collapsibility index is correlated to fasting time and potentially can be used to predict post induction hypotension in children.
Objective: To examine if ultrasound assessment of the diameter and collapsibility index of the SCV is correlated to fasting time and can be a predictor of post induction hypotension in children undergoing general anesthesia.
Design and setting: Prospective observational study in a day case surgical unit in a tertiary university hospital.
Patients: Children aged 0-18 years ASA 1-2 undergoing anesthesia for day case surgery after written and informed consent from parents is obtained according to local ethical permit. Exclusion criteria: ongoing medication for hypertension.
Measurements and results: Based on previous studies (Min Hee Choi et al. Eur J Anaesthesiol 2020; 37:474-481), a sample size of approximately 80 subjects will be needed. Data on fasting time will be collected after informed and written consent has been obtained. Before the induction of anesthesia, the patients will be breathing spontaneously in a supine position. Noninvasive blood pressure will be recorded. An ultrasound examination of SCV will then be performed on cross section of the vessel both in 2D and M-mode and the minimum and maximum diameters of the SCV will be recorded. Collapsibility index will then be calculated from these data as previously described (Min Hee Choi et al. Eur J Anaesthesiology 2020; 37:474-481). After this, the subjects will undergo anesthesia under which blood pressure will be recorded according to departmental standard as usual. SCV collapsibility index will then be investigated for potential significant correlation with fasting time and percentage decrease in blood pressure from baseline after anesthesia induction and during the surgical preparation phase, before start of surgery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Stockholm, Sweden, 171 76
- Karolinska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children undergoing anesthesia for day case surgery in the age group newborn to eighteen years.
Exclusion Criteria:
- Ongoing medication for hypertension. ASA status of more than 2.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SCV Collapsibility index correlation to post induction hypotension
Time Frame: 120 minutes
|
SCV Collapsibility index correlation to percentage change in non invasive blood pressure from baseline recordings pre anesthesia induction
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SCV Collapsibility index correlation to fasting time
Time Frame: 120 min minutes
|
SCV Collapsibility index correlation to fasting time in hours
|
120 min minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting time correlation to post induction hypotension
Time Frame: 120 minutes
|
percentage change in non invasive blood pressure from baseline recordings pre anesthesia induction
|
120 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Per-Arne Lönnqvist, Prof, Karolinska University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KarolinskaSCV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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