NCT01639430

Brief Summary

Retrospective analysis of a quality measurement project examining the quality of vital parameter measurement in consecutive patients \>= 75 years presenting to the emergency department. Primary goal of the study is to evaluate the diagnostic accuracy of body temperature measurement using different methods to diagnose infection in patients \>= 75 years presenting to the emergency department. The secondary goal is to compare the reliability of tympanal and temporal artery thermometry with rectal temperature measurement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
427

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

July 10, 2012

Last Update Submit

July 11, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of rectal, tympanal and temporal artery thermometry to diagnose infection

    The primary outcome measure is the diagnostic accuracy of rectal, tympanal and temporal artery thermometry to diagnose infection in old patients presenting to the ED

    June 2012

Study Arms (1)

Geriatric patients ED

Consecutive patients \>= 75 years in the emergency department.

Other: rectal, tympanal and temporal artery thermometry

Interventions

Temperature measurement was done once in all patients included within the first hour of patients´presentation to the emergency department. Tympanal measurement was carried out by the use of infrared ear thermometry, temporal artery thermometry was done using infrared technology as well.

Geriatric patients ED

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients \>= 75 years presenting to the emergency department of an urban university-affiliated hospital (80.000 attendees per year).

You may qualify if:

  • \>= 75 years
  • given informed consent

You may not qualify if:

  • patients who do not speak the German language
  • patients with unstable cardiorespiratory status
  • presence of contraindications to one of the temperature measurement methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Nürnberg, emergency department

Nuremberg, Bavaria, 90419, Germany

Location

MeSH Terms

Conditions

FeverInfections

Interventions

Administration, Rectal

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, MucosalAdministration, TopicalDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior physician

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 12, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations