NCT04050241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

August 1, 2019

Last Update Submit

October 28, 2019

Conditions

Work Related Stress

Keywords

Mental workloadAnesthesiaLaryngoscopyIntubationPerceived workload

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quantitative workload

    During the laryngoscopy/intubation procedure

Study Arms (2)

Videolaryngoscope

EXPERIMENTAL

Anesthetists performing intubation with the Glidescope videolaryngoscope.

Device: Glidescope intubation

Direct laryngoscope

EXPERIMENTAL

Anesthetists performing intubation with the Mcintosh laryngoscope.

Device: Mcintosh intubation

Interventions

Glidescope intubationDEVICE

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.

Videolaryngoscope
Mcintosh intubationDEVICE

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.

Direct laryngoscope

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anesthetists with expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate

You may not qualify if:

  • Anesthetists that refuse to participate
  • Anesthetists without expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
  • Anesthetists that have left hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Elenora F Orena, PhD

    Fondazione IRCCS Istituto Neurologico Carlo Besta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 8, 2019

Study Start

June 19, 2018

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

October 30, 2019

Record last verified: 2019-10

Locations

IT(1)