NCT04573842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2021

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

10 months

First QC Date

September 28, 2020

Last Update Submit

June 16, 2022

Conditions

Anesthesia ComplicationHypotension on InductionHypovolemia

Outcome Measures

Primary Outcomes (1)

  • SCV Collapsibility index correlation to post induction hypotension

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

    120 minutes

Secondary Outcomes (1)

  • SCV Collapsibility index correlation to fasting time

    120 min minutes

Other Outcomes (1)

  • Fasting time correlation to post induction hypotension

    120 minutes

Interventions

Ultrasound assessment of SCVOTHER

An ultrasound examination of the SCV will be performed before anesthesia induction. Apart from this, the protocol does not differ at all from the ordinary fashion

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children aged 0-18 years ASA 1-2 undergoing anesthesia for day case surgery

You may qualify if:

  • Children undergoing anesthesia for day case surgery in the age group newborn to eighteen years.

You may not qualify if:

  • Ongoing medication for hypertension. ASA status of more than 2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Per-Arne Lönnqvist, Prof

    Karolinska University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

November 30, 2020

Primary Completion

October 7, 2021

Study Completion

October 7, 2021

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)