NCT01801345

Brief Summary

The primary aim of this randomized controlled trial is to examine the effect of fatigue on clinical performance in a simulated obstetric emergency. This scenario was chosen because it is a common clinical situation faced by anesthesia providers on call and therefore likely to occur when a provider is fatigued. Secondary outcomes will include the evaluation of other factors that worsen fatigue related decrement in performance including age, years of training/practice and clinical load prior to study participation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

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

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
2.1 years 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

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

February 25, 2013

Last Update Submit

September 9, 2019

Conditions

Fatigue

Keywords

Human PerformanceClinical Performance

Outcome Measures

Primary Outcomes (1)

  • Clinical performance Score

    Performance score on Stat c-section rating scale based on video rating by 2 raters

    24 months

Secondary Outcomes (1)

  • Stanford Sleepiness Scale

    24months

Study Arms (2)

Rested

OTHER

Subjects will perform the scenario, once during a normal workday (rested)

Other: Rested

Fatigued

ACTIVE COMPARATOR

Subjects will perform the scenario after working a 12-24 hour overnight shift (fatigued).

Other: Fatigued

Interventions

FatiguedOTHER
Fatigued
RestedOTHER
Rested

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All attending anesthesiologists taking overnight call at Evanston Hospital will be eligible participants.

You may not qualify if:

  • Resident physician or trainee, physician not taking overnight in house call.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 28, 2013

Study Start

August 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

US(1)