Call- Associated Acute Fatigue in Surgical Residency

Sleep Deprivation Clinical Trial

— CAFIS  

Official title:

Call-associated Acute Fatigue in Surgical Residency- Subjective Perception or Objective Fact?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284842
• Other study ID #: Philipps-University Marburg
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: January 26, 2011
• Start date: October 2007
• Est. completion date: February 2008

Study information

• Verified date: June 2008
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Sleep Deprivation

Intervention

Other:
• 24-Hour-Call
one 24-Hour-Call within the regular surgical schedule

Locations

Country	Name	City	State
Germany	Department of Visceral-, Thoracic- and Vascular Surgery, Univeristy Hospital Giessen and Marburg- Location Marburg	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sleepiness and Fatigue	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.	4 months