NCT04760249

Brief Summary

At a tertiary care university hospital a specialized interdisciplinary team of paediatric anaesthesiologists and paediatric intensivists was established for providing analgosedation for diagnostic and therapeutic procedures. The aim of the present study was to analyse the incidence and risk factors of adverse events during procedural sedation performed by the Children's Analgosedation Team (CAST).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
784

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 7, 2021

Last Update Submit

February 17, 2021

Conditions

Sedation Complication

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Respiratory, hemodynamic, and other adverse events

    From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours

Secondary Outcomes (9)

  • Incidence of serious adverse events

    From the beginning of sedation (administration of 1. sedation drug) until the end of sedation (patient regained consciousness), assessed up to 6 hours

  • Age

    At the beginning of sedation (administration of 1. sedation drug)

  • Sex

    At the beginning of sedation (administration of 1. sedation drug)

  • American Society of Anesthesiology (ASA) status

    At the beginning of sedation (administration of 1. sedation drug)

  • Date of sedation

    At the beginning of sedation (administration of 1. sedation drug)

  • +4 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children from 1 day to 20 years

You may qualify if:

  • Children (age 0-20 years) receiving procedural sedation
  • Procedural sedation performed by the Children's Analgosedation Team

You may not qualify if:

  • Missing medical records
  • Procedural sedation not performed by the Children's Analgosedation Team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 18, 2021

Study Start

September 1, 2015

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

February 18, 2021

Record last verified: 2021-02