NCT02161497

Brief Summary

The investigators are studying the difference between the history taken from parents prior to their child's anesthesia to information gleaned routinely from a patient information system called Ofek.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

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

June 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

June 10, 2014

Last Update Submit

April 27, 2015

Conditions

Anesthesia

Keywords

Medical History TakingElectronic Health RecordsPediatricsParents

Outcome Measures

Primary Outcomes (1)

  • Number of discrepancies found between clinical history and information received from OFEK system, the reasons for those discrepancies and how they influenced peri-operative clinical decision making.

    Immediate

Secondary Outcomes (4)

  • Average time spent using OFEK system per patient.

    Immediate

  • Average time spent taking clinical history per patient.

    Immediate

  • Number of discrepancies found between clinical history and information received from OFEK system that do not influence peri-operative clinical decision making.

    Immediate

  • Reasons for each discrepancy.

    Immediate

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Parents of children being interviewed at pre anesthesia assessment

You may qualify if:

  • Children presenting with parent/s for pre-operative assessment
  • Ages newborn to 16 years
  • Elective and emergency surgery

You may not qualify if:

  • Premature infants still hospitalized in the Neonatal intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Study Officials

  • David R Hoppenstein, MBBCh

    Meir Medical Center Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 11, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 28, 2015

Record last verified: 2014-06

Locations

IL(1)