We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Call- Associated Acute Fatigue in Surgical Residency (CAFIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01284842
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : January 27, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Sleep Deprivation Other: 24-Hour-Call

Detailed Description:

Summary Background Data:

The effect of acute partial sleep deprivation on surgical proficiency is still controversially discussed. The present study is the first to measure objective physiological parameters of fatigue in respect to subjective perceptions of sleepiness in VR- research of surgical performance.


38 surgeons were explored on three consecutive mornings: prior to a 24-Hour- Call, post-call and after 24 hours resting. Hours of sleep were recorded. Subjective alertness was assessed using the standardized Stanford-Sleepiness-Scale (SSS). Saliva cortisol concentrations and pupillary activity were measured by ELISA and pupillography. The VR-simulator LapSim® was used to assess technical skills through defined low- fidelity VR-tasks "cutting", "clip applying" and cognitive skills through defined high-fidelity VR-tasks "intracorporal suturing", "VR-cholecystectomy". Objective alertness was measured by the standardized d2-Paper-Pencil-Test.

Study Design

Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Call-associated Acute Fatigue in Surgical Residency- Subjective Perception or Objective Fact?
Study Start Date : October 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: 24-Hour-Call
    one 24-Hour-Call within the regular surgical schedule
    Other Name: LapSim

Outcome Measures

Primary Outcome Measures :
  1. Technical and cognitive performance [ Time Frame: 3 days ]
    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.

Secondary Outcome Measures :
  1. Sleepiness and Fatigue [ Time Frame: 4 months ]
    Sleepiness was assessed by Stanford Sleepiness Sclae (SSS) and fatigue was measured through pupillography and saliva cortisol concentration on three consecutive mornings- pre- and post call and after 24 hours resting.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   28 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Lack of required VR- training
  • Lack of informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284842

Department of Visceral-, Thoracic- and Vascular Surgery, Univeristy Hospital Giessen and Marburg- Location Marburg
Marburg, Hessen, Germany, 35041
Sponsors and Collaborators
Philipps University Marburg Medical Center
Principal Investigator: Katja KM Maschuw, MD Philipps University Marburg Medical Center
More Information

Responsible Party: Katja Maschuw, MD, Philipps-University Marburg, Germany
ClinicalTrials.gov Identifier: NCT01284842     History of Changes
Other Study ID Numbers: Philipps-University Marburg
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: June 2008

Keywords provided by Philipps University Marburg Medical Center:
virtual reality

Additional relevant MeSH terms:
Sleep Deprivation
Signs and Symptoms
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders