Workload in Anesthesiological Practice
Primary Purpose
Work Related Stress
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Glidescope intubation
Mcintosh intubation
Sponsored by
About this trial
This is an interventional supportive care trial for Work Related Stress focused on measuring Mental workload, Anesthesia, Laryngoscopy, Intubation, Perceived workload
Eligibility Criteria
Inclusion Criteria:
- Anesthetists with expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
Exclusion Criteria:
- Anesthetists that refuse to participate
- Anesthetists without expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
- Anesthetists that have left hearing loss
Sites / Locations
- Fondazione IRCCS Istituto Neurologico Carlo Besta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Videolaryngoscope
Direct laryngoscope
Arm Description
Anesthetists performing intubation with the Glidescope videolaryngoscope.
Anesthetists performing intubation with the Mcintosh laryngoscope.
Outcomes
Primary Outcome Measures
Perceived workload
Results from the self-reported NASA Task Load Index will be considered as measure of perceived subjective workload
Secondary Outcome Measures
Quantitative workload
Reaction times to a secondary auditory task will be used as a measure of mental workload
Full Information
NCT ID
NCT04050241
First Posted
August 1, 2019
Last Updated
October 28, 2019
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
1. Study Identification
Unique Protocol Identification Number
NCT04050241
Brief Title
Workload in Anesthesiological Practice
Official Title
Objective and Subjective Mental Workload During Direct and Indirect Laryngoscopy in Anesthetists: an In-vivo, Cross-over Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates differences in perceived and objective workload in anesthetists during intubation procedure with a direct (Mcintosh) or indirect (Glidescope) laryngoscope. Expert anesthetists will perform 3 intubations per device, while completing a secondary task, during which reaction times to an auditory stimulus will be recorded, and will complete a questionnaire (the NASA-Task Load Index) to evaluate their perceived workload at the end of each procedure.
Detailed Description
Intubation and laryngoscopy are the most demanding procedure in anesthesiological routine clinical practice, associated with high workload. The measurement and management of workload is considered important in anesthesiology to prevent work-related stress and errors in performance. New devices, thanks to advances in technology, seem promising in reducing operators' workload and improving safety and success of intubation processes.
Therefore, in this study, based on previous results, the hypothesis that the Glidescope videolaryngoscope reduces operators' perceived and and objective workload, as compared to the standard Mcintosh laryngoscope, will be tested.
Expert anesthetists will perform 3 intubations per device in a randomized order, while completing a secondary task, during which reaction times (verbal responses) to an auditory stimulus (a clacson) will be recorded, and operators will complete a questionnaire (the NASA-Task Load Index) to evaluate their perceived workload at the end of each procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work Related Stress
Keywords
Mental workload, Anesthesia, Laryngoscopy, Intubation, Perceived workload
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videolaryngoscope
Arm Type
Experimental
Arm Description
Anesthetists performing intubation with the Glidescope videolaryngoscope.
Arm Title
Direct laryngoscope
Arm Type
Experimental
Arm Description
Anesthetists performing intubation with the Mcintosh laryngoscope.
Intervention Type
Device
Intervention Name(s)
Glidescope intubation
Intervention Description
Anesthetists will perform intubation in patients undergoing elective neurosurgery with the Glidescope videolaryngoscope, while completing a secondary auditory task. Response times to the secondary task will be recorded, and operators will complete the NASA Task Load Index questionnaire at the end of each procedure.
Intervention Type
Device
Intervention Name(s)
Mcintosh intubation
Intervention Description
Anesthetists will perform intubation in patients undergoing elective neurosurgery with the Mcintosh laryngoscope, while completing a secondary auditory task. Response times to the secondary task will be recorded, and operators will complete the NASA Task Load Index questionnaire at the end of each procedure.
Primary Outcome Measure Information:
Title
Perceived workload
Description
Results from the self-reported NASA Task Load Index will be considered as measure of perceived subjective workload
Time Frame
Immediately after the procedure/intervention
Secondary Outcome Measure Information:
Title
Quantitative workload
Description
Reaction times to a secondary auditory task will be used as a measure of mental workload
Time Frame
During the laryngoscopy/intubation procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anesthetists with expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
Exclusion Criteria:
Anesthetists that refuse to participate
Anesthetists without expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
Anesthetists that have left hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elenora F Orena, PhD
Organizational Affiliation
Fondazione IRCCS Istituto Neurologico Carlo Besta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta
City
Milan
ZIP/Postal Code
20133
Country
Italy
12. IPD Sharing Statement
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Workload in Anesthesiological Practice
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