Impact of Noise on Anesthesiologists' and Trainees' Situational Awareness in a High Fidelity Simulation Environment

October 22, 2019 updated by: Jean-François Gagne, Maisonneuve-Rosemont Hospital

Examining the Impact of Noise on Anesthesiologists' and Trainees' Situational Awareness in a High Fidelity Simulation Environment: a Prospective, Simulation-based, Randomized Trial

The study is a single blinded randomized control trial. Participants were blinded to the purpose of the study and to the level of noise they would be exposed. Anesthesiology residents and certified anesthesiologists were recruited.The goal of this study was to measure the time needed to initiate treatment(TNIT) of a severe bradycardia while performing a spinal anesthesia in a high-fidelity simulation environment with either a low or a high ambient dB-level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sample size To the investigators' knowledge, no similar study was done and predicting the difference in reaction time depending on level of noise is difficult. In comparable studies, sample size is small. The investigators then used a convenience sample based on the number of residents and staffs anesthesiologists who agreed to participate; the number of participants in this study exceeds the number of participants in previous research. Using the t value and the degrees-of-freedom of the unpaired t-test, the investigators calculated the effect size (r) to characterize the magnitude of the effect and evaluate if the sample size is enough to answer the research hypothesis. An r value of around 0.2 was considered a "weak" effect, 0.5 "medium", and 0.8 "strong". We recruited 15 participants in each group.

Simulation scenario The scenario was performed in situ in an operating room of the investigators' tertiary care hospital. It consisted of doing a spinal anesthesia for a 61 years old woman for a total hip replacement. She was known for stable asthma, high blood pressure and dyslipidemia. Upon entering the room, the anesthesiology evaluation and signed consentment were already completed. A simulated patient with a lumbar puncture simulator fixed on its back (Kyoto Kagaku M43B Lumbar Puncture Simulator II ®) was in position on the operating table for the technique. A simulated anesthesiology nurse was also present in the room. Standard monitoring with EKG, pulse oximeter, non invasive blood pressure were projected on a remotely controlled monitor with Castle Andersen ApS' SimMon app®. Simulated intravenous access was also already in place with the possibility to inject drugs if needed.

The participant then proceeded to the technique. Upon completion of local anesthesia, a mild auto-resolutive drop in heart rate from 85 to 65 without any other hemodynamic change. This benign change was used to try addressing hyper vigilance which is often happening in simulation scenarios. At the moment of dural puncture, a vasovagal event happened. It consisted of a standardised progressive diminution of the heart rate from 80 bpm to 30 bpm. After 10 seconds, blood pressure would fall to 70/40 with appropriate alarms at standard levels. The simulated patient did not tell its discomfort spontaneously but answered to questions if asked. After appropriate treatment, (putting the patient in dorsal position, administration of vasopressors or parasympatholytics) vital signs normalised in less than 30 seconds. The participant was then assigned to complete a questionnaire in another room.

Data Collection All participants were filmed for further revision. Demographics were gathered with a questionnaire. Collected datas were age, sex, resident or anesthesiologist status, number of years as a certified anesthesiologist or year of residency and if a hearing deficit was previously diagnosed. Participants also rated scenario realism on a 1 to 5 Likert scale.

Noise sensitivity was measured with Weinstein's Noise Sensitivity Scale, a 21-items validated questionnaire

After completion, collected datas were explained to the participants, questions were answered and if needed a more complete debriefing was made.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be a certified anesthesiologist or anesthesiology resident
  • To have at least two months of anesthesiology exposure
  • To consent to the study

Exclusion Criteria:

  • To refuse to participate
  • To have a hearing impairment diagnosis that affected anesthesiology practice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-dB Environment
While performing the spinal anesthesia, the participants were exposed to a pre-recorded soundtrack of one of the investigators' operating rooms while the anesthesiology team was performing a spinal anesthesia. It included instruments noise and discussion but alarms, pulse oximetry and discussion with the patient were removed. The level of the soundtrack was set to be at 70 dB with peaks up to 100 dB, this level was recorded for every participant with Iphone™ application SoundMeter X 10.3 by Faber Acoustical, which has been both choosed in accordance with similar studies. The average noise was measured using the LEq value on a ''A'' scale (dB(A)) which correlate with frequencies perceived by the human ear. Speakers where placed at each corner of the room. Since literature describe that noise can initially enhance performance but is a transitory effect, the investigators decided to expose the experimental group to the maximum level of noise without any gradation.
Other: Exposition to high-dB soundtrack
Already stated
No Intervention: Low-dB Environment
The control group performed the same spinal anesthesia simulation scenario but without any soundtrack. The ambient noise in the room was recorded with the same method for each participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Initiate Treatment of a severe bradycardia (TNIT)
Time Frame: Through scenario completion, an average of 30 minutes
The time to treatment of the vasovagal event was measured in seconds from the beginning of the bradycardia to the moment of appropriate treatment as previously defined(putting the simulated patient in dorsal position, administration of vasopressors or parasympatholytics). The investigators use this time as an indirect and pragmatic measure of participants' situational awareness without the need to regularly stop the scenario as a Situation Awareness Rating Technique (SAGAT) would need.
Through scenario completion, an average of 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to completed the task
Time Frame: Through scenario completion, an average of 30 minutes
The time to realize the task which is from the beginning of the technique (landmark palpation) until cerebro-spinal fluid is obtained.
Through scenario completion, an average of 30 minutes
Swedish Occupational Fatigue Inventory (SOFI)Score
Time Frame: Through scenario completion, an average of 30 minutes
The Swedish Occupational Fatigue Inventory is a 5 category questionnaire to assess occupational fatigue.(Lack of energy, physical exertion,physical discomfort,lack of motivation and sleepiness). Each category is declined in 4 adjectives that the participant has to rate on a scale from 0 to 6 (low agreement to high agreement). Results are reported for each category as the sum of each of its adjective from 0 to 24 (from low occupational fatigue to high occupational fatigue.
Through scenario completion, an average of 30 minutes
NASA Task Load Index (NASA-TLX) Score
Time Frame: Through scenario completion, an average of 30 minutes

The participant has to rate each 6 category on a continous scale of 21 points as shown below.

  • Mental Demand From very low to very high
  • Physical Demand From very low to very high
  • Temporal demand From very low to very high
  • Performance From perfect to failure (This scale in interpreted in a reverse way)
  • Effort From very low to very high
  • Frustration From very low to very high The next step for the participant is to do a pairwise comparison of each category by selection the most contributive.

Results are presented with transformation of the 21 points to a 100 points scale as a rating from 0 to 100 ( Low to high task load) By using pairwise comparison, a weighted global result is also presented with a score from 0 to 100 (Low to high task load)
Through scenario completion, an average of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

Université de Montréal

Investigators

  • Principal Investigator: Jean-François Gagné, MD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2019

Primary Completion (Actual)

April 24, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 22, 2019

First Posted (Actual)

October 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SituationalAwarenessNoise

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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