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

NCT04138082 | Completed

• 1 other identifier: SituationalAwarenessNoise
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Noise; Adverse Effect

Keywords

Situational Awareness; Randomized-Control Trial; Medical Simulation; Patient Security

Outcome Measures

Primary Outcomes (1)

• Time To Initiate Treatment of a severe bradycardia (TNIT)

  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 Outcomes (3)

• Time to completed the task

  Through scenario completion, an average of 30 minutes

• Swedish Occupational Fatigue Inventory (SOFI)Score

  Through scenario completion, an average of 30 minutes

• NASA Task Load Index (NASA-TLX) Score

  Through scenario completion, an average of 30 minutes

Study Arms (2)

High-dB Environment

EXPERIMENTAL

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

Low-dB Environment

NO INTERVENTION

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.

Interventions

Exposition to high-dB soundtrack OTHER

Already stated

High-dB Environment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Université de Montréal: collaborator

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (14)

• Katz JD. Noise in the operating room. Anesthesiology. 2014 Oct;121(4):894-8. doi: 10.1097/ALN.0000000000000319. No abstract available.

  PMID: 24878496 BACKGROUND

• Murthy VS, Malhotra SK, Bala I, Raghunathan M. Detrimental effects of noise on anaesthetists. Can J Anaesth. 1995 Jul;42(7):608-11. doi: 10.1007/BF03011878.

  PMID: 7553997 BACKGROUND

• Stevenson RA, Schlesinger JJ, Wallace MT. Effects of divided attention and operating room noise on perception of pulse oximeter pitch changes: a laboratory study. Anesthesiology. 2013 Feb;118(2):376-81. doi: 10.1097/ALN.0b013e31827d417b.

  PMID: 23263015 BACKGROUND

• Kurmann A, Peter M, Tschan F, Muhlemann K, Candinas D, Beldi G. Adverse effect of noise in the operating theatre on surgical-site infection. Br J Surg. 2011 Jul;98(7):1021-5. doi: 10.1002/bjs.7496.

  PMID: 21618484 BACKGROUND

• Broom MA, Capek AL, Carachi P, Akeroyd MA, Hilditch G. Critical phase distractions in anaesthesia and the sterile cockpit concept. Anaesthesia. 2011 Mar;66(3):175-9. doi: 10.1111/j.1365-2044.2011.06623.x.

  PMID: 21320085 BACKGROUND

• Drzymalski DM, Ceruzzi J, Camann WR. Noise in the obstetric operating room. Int J Obstet Anesth. 2017 Feb;29:87-88. doi: 10.1016/j.ijoa.2016.10.008. Epub 2016 Oct 28. No abstract available.

  PMID: 27884668 BACKGROUND

• Fritsch MH, Chacko CE, Patterson EB. Operating room sound level hazards for patients and physicians. Otol Neurotol. 2010 Jul;31(5):715-21. doi: 10.1097/MAO.0b013e3181d8d717.

  PMID: 20431500 BACKGROUND

• Wang X, Zeng L, Li G, Xu M, Wei B, Li Y, Li N, Tao L, Zhang H, Guo X, Zhao Y. A cross-sectional study in a tertiary care hospital in China: noise or silence in the operating room. BMJ Open. 2017 Sep 18;7(9):e016316. doi: 10.1136/bmjopen-2017-016316.

  PMID: 28928180 BACKGROUND

• Fitzgerald G, O'Donnell B. "In somno securitas" anaesthetists' noise exposure in Orthopaedic operating theatres. Ir Med J. 2012 Jul-Aug;105(7):239-41.

  PMID: 23008884 BACKGROUND

• Wright MC, Taekman JM, Endsley MR. Objective measures of situation awareness in a simulated medical environment. Qual Saf Health Care. 2004 Oct;13 Suppl 1(Suppl 1):i65-71. doi: 10.1136/qhc.13.suppl_1.i65.

  PMID: 15465958 BACKGROUND

• Schulz CM, Endsley MR, Kochs EF, Gelb AW, Wagner KJ. Situation awareness in anesthesia: concept and research. Anesthesiology. 2013 Mar;118(3):729-42. doi: 10.1097/ALN.0b013e318280a40f.

  PMID: 23291626 BACKGROUND

• Enser M, Moriceau J, Abily J, Damm C, Occhiali E, Besnier E, Clavier T, Lefevre-Scelles A, Dureuil B, Compere V. Background noise lowers the performance of anaesthesiology residents' clinical reasoning when measured by script concordance: A randomised crossover volunteer study. Eur J Anaesthesiol. 2017 Jul;34(7):464-470. doi: 10.1097/EJA.0000000000000624.

  PMID: 28394819 BACKGROUND

• McNeer RR, Bennett CL, Dudaryk R. Intraoperative Noise Increases Perceived Task Load and Fatigue in Anesthesiology Residents: A Simulation-Based Study. Anesth Analg. 2016 Feb;122(2):512-25. doi: 10.1213/ANE.0000000000001067.

  PMID: 26797555 BACKGROUND

• Feuerbacher RL, Funk KH, Spight DH, Diggs BS, Hunter JG. Realistic distractions and interruptions that impair simulated surgical performance by novice surgeons. Arch Surg. 2012 Nov;147(11):1026-30. doi: 10.1001/archsurg.2012.1480.

  PMID: 22801787 BACKGROUND

Study Officials

• Jean-François Gagné, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blindly assigned to the high dB or low dB group. They were also blinded to the purpose of the study until completion.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 24, 2019
• Study Start: February 28, 2019
• Primary Completion: April 24, 2019
• Study Completion: May 1, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)