Workload in Anesthesiological Practice

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

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.

Study Overview

• Status: Completed
• Conditions: Work Related Stress
• Intervention / Treatment: Device: Glidescope intubation; Device: Mcintosh intubation

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Neurologico Carlo Besta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Videolaryngoscope; Anesthetists performing intubation with the Glidescope videolaryngoscope.	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.
Experimental: Direct laryngoscope; Anesthetists performing intubation with the Mcintosh laryngoscope.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative workload	Reaction times to a secondary auditory task will be used as a measure of mental workload	During the laryngoscopy/intubation procedure

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Investigators: Principal Investigator: Elenora F Orena, PhD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Anesthesia; Intubation; Laryngoscopy; Mental workload; Perceived workload
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: AR-INNCB-02-2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No