Sleep DeprivationCAFISNCT01284842
Call- Associated Acute Fatigue in Surgical Residency
An observational study of Sleep Deprivation, run by Philipps University Marburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 28 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- 24-Hour-Call
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * 38 surgeons (20 male, 18 female) * 4 senior registrars, 15 junior registrars, 19 interns * age 24-48 years; mean 30 years
Who may be able to join
- 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
Who cannot join
- Lack of required VR- training
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Visceral-, Thoracic- and Vascular Surgery, Univeristy Hospital Giessen and Marburg- Location Marburg
Marburg, Hesse, 35041
About this study
Official title: Call-associated Acute Fatigue in Surgical Residency- Subjective Perception or Objective Fact?
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.
Read the 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.
- Conditions
- Sleep Deprivation
- Being tested
- 24-Hour-Call
- Keywords
- sleep-deprivation, virtual reality, residency, performance
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-Hour-CallOther
Also called LapSim
one 24-Hour-Call within the regular surgical schedule
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Investigators
- Katja KM Maschuw, MD, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284842
- Sponsor's protocol ID
- Philipps-University Marburg
- Acronym
- CAFIS
- Status last verified
- Jun 2008
- First submitted
- 26 Jan 2011
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Call-associated Acute Fatigue in Surgical Residency- Subjective Perception or Objective Fact?
- ClinicalTrials.gov ID
- NCT01284842
- Acronym / sponsor ID
- CAFIS / Philipps-University Marburg
- Conditions
- Sleep Deprivation
- Keywords
- sleep-deprivation, virtual reality, residency, performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 28 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * 38 surgeons (20 male, 18 female) * 4 senior registrars, 15 junior registrars, 19 interns * age 24-48 years; mean 30 years
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Lack of required VR- training
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-Hour-CallAlso: LapSimone 24-Hour-Call within the regular surgical schedule | Other | – |
Primary outcome
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.
1 secondary outcome
Sleepiness and Fatigue
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja KM Maschuw, MD principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical and cognitive performance (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.