Work Related StressNCT04050241
Workload in Anesthesiological Practice
A study testing Glidescope intubation and Mcintosh intubation in people with Work Related Stress, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Work Related Stress
- What is being tested?
- Glidescope intubation and Mcintosh intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2018to 10 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Anesthetists with expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
Who cannot join
- Anesthetists that refuse to participate
- Anesthetists without expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
- Anesthetists that have left hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Work Related Stress
- Being tested
- Glidescope intubation, Mcintosh intubation
- Keywords
- Mental workload, Anesthesia, Laryngoscopy, Intubation, Perceived workload
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope | Experimental | Anesthetists performing intubation with the Glidescope videolaryngoscope. Receives: Device: Glidescope intubation |
| Direct laryngoscope | Experimental | Anesthetists performing intubation with the Mcintosh laryngoscope. Receives: Device: Mcintosh intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived workload
Results from the self-reported NASA Task Load Index will be considered as measure of perceived subjective workload
Measured: Immediately after the procedure/intervention
Secondary outcomes (1)
Quantitative workload
Reaction times to a secondary auditory task will be used as a measure of mental workload
Measured: During the laryngoscopy/intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start19 Jun 2018
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work Related StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Orena, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Investigators
- Elenora F Orena, PhD, Principal investigator, Fondazione IRCCS Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050241
- Sponsor's protocol ID
- AR-INNCB-02-2011
- Status last verified
- Oct 2019
- First submitted
- 1 Aug 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective and Subjective Mental Workload During Direct and Indirect Laryngoscopy in Anesthetists: an In-vivo, Cross-over Randomized Study
- ClinicalTrials.gov ID
- NCT04050241
- Acronym / sponsor ID
- AR-INNCB-02-2011
- Conditions
- Work Related Stress
- Keywords
- Mental workload, Anesthesia, Laryngoscopy, Intubation, Perceived workload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope | Experimental | Device: Glidescope intubationAnesthetists performing intubation with the Glidescope videolaryngoscope. |
| Direct laryngoscope | Experimental | Device: Mcintosh intubationAnesthetists performing intubation with the Mcintosh laryngoscope. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthetists with expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
Key exclusion criteria (3 listed)
- Anesthetists that refuse to participate
- Anesthetists without expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
- Anesthetists that have left hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glidescope intubationAnesthetists 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. | Device | Videolaryngoscope |
| Mcintosh intubationAnesthetists 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. | Device | Direct laryngoscope |
Primary outcome
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
1 secondary outcome
Quantitative workload
Time frame: During the laryngoscopy/intubation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elenora F Orena, PhD principal investigator
Fondazione IRCCS Istituto Neurologico Carlo Besta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glidescope intubation and Mcintosh intubation in people with Work Related Stress, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived workload (time frame: Immediately after the procedure/intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.