The Effect of Fatigue on the Clinical Performance | NCT01801345

Studies
The Effect of Fatigue on the Clinical Performance

NCT01801345

Sponsor

Endeavor Health

Status

Completed

Last Update Posted

Sep 11, 2019Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Fatigue

Interventions

Fatigued
Rested

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Feb 25, 2013

First Submission Date that Met QC Criteria

Feb 26, 2013

First Posted Date

Feb 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2019

Last Update Posted Date

Sep 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fatigued	Other		Fatigued
Rested

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical performance Score	Performance score on Stat c-section rating scale based on video rating by 2 raters	24 months

Secondary Outcomes

Measure	Description	Time Frame
Stanford Sleepiness Scale	SSS scores in rested and fatigue arms	24months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evanston Hospital		Evanston	Illinois	60201	United States

Condition Browse Module

MeSH Terms

ID	Term
D005221	Fatigue

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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