NCT01284842

Brief Summary

The study aimed to evaluate the effects of 24-Hour-Call-associated acute partial sleep deprivation on surgical residents' technical and cognitive performance in a virtual reality (VR) setting. Physiological parameters were used to quantify fatigue in respect to hours of sleep and subjective degrees of sleepiness. Technical performance and cognitive skills were assessed through low- and high fidelity tasks usig the VR- simulator LapSim. Objective alertness was measured by the standardized d2-Paper-Pencil-Test. Cited assessments were performed on three consecutive mornings- pre- and post-call as after 24 hours resting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
Last Updated

January 27, 2011

Status Verified

June 1, 2008

Enrollment Period

4 months

First QC Date

January 26, 2011

Last Update Submit

January 26, 2011

Conditions

Keywords

sleep-deprivationvirtual realityresidencyperformance

Outcome Measures

Primary Outcomes (1)

  • Technical and cognitive performance

    Technical and cognitive performance was assessed in a VR-setting of defined parameters of performance and the d2-Paper-Pencil-Test on three consecutive mornings- pre- and post call and after 24 hours resting.

    3 days

Secondary Outcomes (1)

  • Sleepiness and Fatigue

    4 months

Interventions

one 24-Hour-Call within the regular surgical schedule

Also known as: LapSim

Eligibility Criteria

Age28 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* 38 surgeons (20 male, 18 female) * 4 senior registrars, 15 junior registrars, 19 interns * age 24-48 years; mean 30 years

You may qualify if:

  • Surgical interns, junior- or senior residents
  • Successful completion of a minimum of 10 basic VR- tasks with the VR- simulator LapSim: "camera navigation", "coordination", "clip applying", "Cutting", and "diathermy cutting" and a minimum of 5 sessions of advanced VR- tasks: "fine dissection", "intracorporal suturing" and "VR- cholecystectomy"
  • Voluntary participation
  • Written informed consent

You may not qualify if:

  • Lack of required VR- training
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral-, Thoracic- and Vascular Surgery, Univeristy Hospital Giessen and Marburg- Location Marburg

Marburg, Hesse, 35041, Germany

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

CD56 Antigen

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Neural Cell Adhesion MoleculesCell Adhesion Molecules, NeuronalCell Adhesion MoleculesMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsAntigens, Differentiation, T-LymphocyteAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkers

Study Officials

  • Katja KM Maschuw, MD

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

October 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 27, 2011

Record last verified: 2008-06

Locations