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Completed

NCT Number: NCT04050241

Workload in Anesthesiological Practice

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glidescope intubation

Device

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

Device

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 outcomes

  1. Perceived workload

    Time frame: Immediately after the procedure/intervention

    Results from the self-reported NASA Task Load Index will be considered as measure of perceived subjective workload

Secondary outcomes

  1. Quantitative workload

    Time frame: During the laryngoscopy/intubation procedure

    Reaction times to a secondary auditory task will be used as a measure of mental workload

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2019
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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