Noise; Adverse EffectNCT04138082
Impact of Noise on Anesthesiologists' and Trainees' Situational Awareness in a High Fidelity Simulation Environment
A study testing Exposition to high-dB soundtrack in people with Noise; Adverse Effect, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Noise; Adverse Effect
- What is being tested?
- Exposition to high-dB soundtrack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 28 Feb 2019to 1 May 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be a certified anesthesiologist or anesthesiology resident
- To have at least two months of anesthesiology exposure
- To consent to the study
Who cannot join
- To refuse to participate
- To have a hearing impairment diagnosis that affected anesthesiology practice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Noise; Adverse Effect
- Being tested
- Exposition to high-dB soundtrack
- Keywords
- Situational Awareness, Randomized-Control Trial, Medical Simulation, Patient Security
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposition to high-dB soundtrackOther
Already stated
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through scenario completion, an average of 30 minutes
Secondary outcomes (3)
Time to completed the task
The time to realize the task which is from the beginning of the technique (landmark palpation) until cerebro-spinal fluid is obtained.
Measured: Through scenario completion, an average of 30 minutes
Swedish Occupational Fatigue Inventory (SOFI)Score
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.
Measured: Through scenario completion, an average of 30 minutes
NASA Task Load Index (NASA-TLX) Score
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)
Measured: Through scenario completion, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start28 Feb 2019
- Primary completion24 Apr 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Noise; Adverse EffectStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Principal investigator, Jean-François Gagne, Maisonneuve-Rosemont Hospital
- Investigators
- Jean-François Gagné, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138082
- Sponsor's protocol ID
- SituationalAwarenessNoise
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katz JD. Noise in the operating room. Anesthesiology. 2014 Oct;121(4):894-8. doi: 10.1097/ALN.0000000000000319. No abstract available.
PubMed 24878496Murthy 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.
PubMed 7553997Stevenson 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.
PubMed 23263015Kurmann 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.
PubMed 21618484Broom 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.
PubMed 21320085Drzymalski 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.
PubMed 27884668Fritsch 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.
PubMed 20431500Wang 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.
PubMed 28928180Fitzgerald G, O'Donnell B. "In somno securitas" anaesthetists' noise exposure in Orthopaedic operating theatres. Ir Med J. 2012 Jul-Aug;105(7):239-41.
PubMed 23008884Wright 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.
PubMed 15465958Schulz 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.
PubMed 23291626Enser 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.
PubMed 28394819McNeer 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.
PubMed 26797555Feuerbacher 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.
PubMed 22801787
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Noise on Anesthesiologists' and Trainees' Situational Awareness in a High Fidelity Simulation Environment: a Prospective, Simulation-based, Randomized Trial
- ClinicalTrials.gov ID
- NCT04138082
- Acronym / sponsor ID
- SituationalAwarenessNoise
- Conditions
- Noise; Adverse Effect
- Keywords
- Situational Awareness, Randomized-Control Trial, Medical Simulation, Patient Security
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 24 Oct 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dB Environment | Experimental | Other: Exposition to high-dB soundtrackWhile 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- To be a certified anesthesiologist or anesthesiology resident
- To have at least two months of anesthesiology exposure
- To consent to the study
Key exclusion criteria (2 listed)
- To refuse to participate
- To have a hearing impairment diagnosis that affected anesthesiology practice.
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 |
|---|---|---|
| Exposition to high-dB soundtrackAlready stated | Other | High-dB Environment |
Primary outcome
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.
3 secondary outcomes
Time to completed the task
Time frame: Through scenario completion, an average of 30 minutes
Swedish Occupational Fatigue Inventory (SOFI)Score
Time frame: 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
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 24 Oct 2019.
- Background: PubMed 24878496Katz JD. Noise in the operating room. Anesthesiology. 2014 Oct;121(4):894-8. doi: 10.1097/ALN.0000000000000319. No abstract available.
- Background: PubMed 7553997Murthy 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.
- Background: PubMed 23263015Stevenson 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.
- Background: PubMed 21618484Kurmann 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.
- Background: PubMed 21320085Broom 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.
- Background: PubMed 27884668Drzymalski 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.
- Background: PubMed 20431500Fritsch 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.
- Background: PubMed 28928180Wang 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.
- Background: PubMed 23008884Fitzgerald G, O'Donnell B. "In somno securitas" anaesthetists' noise exposure in Orthopaedic operating theatres. Ir Med J. 2012 Jul-Aug;105(7):239-41.
- Background: PubMed 15465958Wright 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.
- Background: PubMed 23291626Schulz 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.
- Background: PubMed 28394819Enser 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.
- Individual participant dataSharing planned: No
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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.
Jean-François Gagné, MD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposition to high-dB soundtrack in people with Noise; Adverse Effect, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 3 inclusion and 2 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 24 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 Canada. 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?
Time To Initiate Treatment of a severe bradycardia (TNIT) (time frame: Through scenario completion, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04138082, which also lists 14 linked publications.
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 24 Oct 2019.