Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT04573842
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Intra operative hypotension is a risk factor in pediatric anesthesia (McCann ME et al.Pediatr Anesth 2014; 24: 68-73). In summary, the study aims at examine if ultrasound assessment of the diameter and collapsibility index of the subclavian vein is correlated to fasting time and if they are correlated to the degree of hypotension seen post anesthesia induction in children undergoing general anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Complication; Hypotension on Induction; Hypovolemia	Other: Ultrasound assessment of SCV

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 Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
• Actual Study Start Date: Nov 30, 2020
• Actual Primary Completion Date: Oct 7, 2021
• Actual Study Completion Date: Oct 7, 2021

Outcome Measures

Primary Outcome Measures

1. SCV Collapsibility index correlation to post induction hypotension [120 minutes]

   SCV Collapsibility index correlation to percentage change in non invasive blood pressure from baseline recordings pre anesthesia induction

Secondary Outcome Measures

1. SCV Collapsibility index correlation to fasting time [120 min minutes]

   SCV Collapsibility index correlation to fasting time in hours

Other Outcome Measures

1. Fasting time correlation to post induction hypotension [120 minutes]

   percentage change in non invasive blood pressure from baseline recordings pre anesthesia induction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden	171 76

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Study Chair: Per-Arne Lönnqvist, Prof, Karolinska University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jacob Karlsson, Principal Investigator, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT04573842
• Other Study ID Numbers: KarolinskaSCV
• First Posted: Oct 5, 2020
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypotension; Hypovolemia

Study Results

No Results Posted as of Jun 21, 2022