Call- Associated Acute Fatigue in Surgical Residency (CAFIS)

This study has been completed.
Sponsor:
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01284842
First received: January 26, 2011
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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 Intervention
Sleep Deprivation
Other: 24-Hour-Call

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Call-associated Acute Fatigue in Surgical Residency- Subjective Perception or Objective Fact?

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Technical and cognitive performance [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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:
  • Sleepiness and Fatigue [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 38
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 24-Hour-Call
    one 24-Hour-Call within the regular surgical schedule
    Other Name: LapSim
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.

Methods:

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.

  Eligibility

Ages Eligible for Study:   28 Years to 50 Years
Genders Eligible for Study:   Both
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
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284842

Locations
Germany
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
Investigators
Principal Investigator: Katja KM Maschuw, MD Philipps- University, Marburg, Germany
  More Information

No publications provided

Responsible Party: Katja Maschuw, MD, Philipps-University Marburg, Germany
ClinicalTrials.gov Identifier: NCT01284842     History of Changes
Other Study ID Numbers: Philipps-University Marburg
Study First Received: January 26, 2011
Last Updated: January 26, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
sleep-deprivation
virtual reality
residency
performance

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

ClinicalTrials.gov processed this record on September 22, 2014