Workload in Anesthesiological Practice

Work Related Stress Clinical Trial

Official title:

Objective and Subjective Mental Workload During Direct and Indirect Laryngoscopy in Anesthetists: an In-vivo, Cross-over Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050241
• Other study ID #: AR-INNCB-02-2011
• Status: Completed
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: July 10, 2019

Study information

• Verified date: October 2019
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Occupational Stress
• Work Related Stress

Intervention

Device:
• Glidescope intubation
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.
• Mcintosh intubation
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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived workload	Results from the self-reported NASA Task Load Index will be considered as measure of perceived subjective workload	Immediately after the procedure/intervention
Secondary	Quantitative workload	Reaction times to a secondary auditory task will be used as a measure of mental workload	During the laryngoscopy/intubation procedure