NCT03615898

Brief Summary

Background: The incidents related to medication are an important cause of avoidable health damage in the perioperative environment. Objectives: Describe the incidents related to medication reported in the national communication system of incidents in anaesthesia and resuscitation in Spain (SENSAR), and their relationship with morbidity. Methods: The investigators studied the incidents identified as medication errors of all those reported in the SENSAR database between January 1, 2008 and December 31, 2017. The researchers performed a descriptive analysis of independent variables: type of medication incident, moment in which the incident occurred, drug group involved and then a logistic regression in order to establish the relationship with the dependent variable: morbidity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7,072

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2008

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

10 years

First QC Date

July 31, 2018

Last Update Submit

September 7, 2018

Conditions

Keywords

medication incidents reporting system errors morbidity Spain

Outcome Measures

Primary Outcomes (1)

  • INCIDENTS RELATED TO MEDICATION

    Describe the incidents related to medication reported in the national communication system of incidents in anaesthesia and resuscitation in Spain (SENSAR), and their relationship with morbidity.

    10 YEARS

Secondary Outcomes (1)

  • MORBILITY

    10 YEARS

Interventions

TEN YEAR ANALYSIS OF MEDICATION ERRORS IN THE SPANISH INCIDENTS REPORTING SYSTEM IN ANAESTHESIA

Eligibility Criteria

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

The study population consisted of communications and analysis of the SENSAR database between January 1, 2008 and December 31, 2017

You may qualify if:

  • Incidents reported during the 10 years evaluation period.

You may not qualify if:

  • Reports with missing data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sanduende-Otero Y, Villalon-Coca J, Romero-Garcia E, Diaz-Cambronero O, Barach P, Arnal-Velasco D. Patterns in medication incidents: A 10-yr experience of a cross-national anaesthesia incident reporting system. Br J Anaesth. 2020 Feb;124(2):197-205. doi: 10.1016/j.bja.2019.10.013. Epub 2019 Nov 25.

Related Links

Study Officials

  • EVA ROMERO-GARCIA, MD

    Hospital Universitario La Fe

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 6, 2018

Study Start

January 1, 2008

Primary Completion

December 31, 2017

Study Completion

July 31, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share