Patient SafetyNCT04846660
Impact of Production Pressure in the Block Room on Patient Safety
A study testing Production pressure in people with Patient Safety and Anesthesia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
This randomized, single blinded simulation based study investigates the impact that production pressure can have on the safety of patients undergoing regional anesthesia. We created a high fidelity scenario where anesthesiologists and trainees were to perform a single shot infraclavicular ultrasound guided block. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Anesthesia
- What is being tested?
- Production pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2021to 30 May 2021
- 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 performed at least 10 regional anesthesia techniques including 5 infraclavicular blocks
- To consent to the study
Who cannot join
- To refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impact of Production Pressure in the Regional Anesthesia Block Room on Patient Safety, a Randomized Single Blind Study in a High Fidelity Simulation Environment
This randomized, single blinded simulation based study investigates the impact that production pressure can have on the safety of patients undergoing regional anesthesia. We created a high fidelity scenario where anesthesiologists and trainees were to perform a single shot infraclavicular ultrasound guided block. Participants were randomly assigned to the intervention or control group. Participants assigned to the intervention group were exposed to various production pressure generating interventions. The goal of this study was to look at the impact of production pressure on patient safety by scoring anesthesiologists' and trainees' performance and examining the differences between the two groups.
Read the detailed description
Sample size:
To our knowledge, no studies were performed to evaluate the impact of production pressure on anesthesiologists nor on how to emulate production pressure in a simulated environment. Although it is known that production pressure affects negatively healthcare workers' performance, it remains difficult to predict its impact on a scoring system such as the RAPS assessment tool. Therefore, we used a convenience sample based on the number of residents and staffs anesthesiologists who agreed to participate. 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 intend to recruit between 10 to 20 participants in each group.
Scenario:
Participants were asked to obtain consent and perform a single shot infraclavicular ultrasound guided block on a 50 year old woman with mild COPD. The simulation took place in situ in a regional anesthesia block room. Upon entering the room, the anesthesiology evaluation was already completed. A CAE infraclavicular block simulator was installed on a simulated patient. A simulated anesthesiology nurse was also present to assist only. All preparation steps and safety measures had to be initiated by the participant. Participants in the intervention group were exposed to 4 standardized pre-recorded audio interventions, encouraging them to proceed faster. The choice of these interventions was based on articles and surveys detailing the common sources of production pressure for the anesthesiologist.
Data collection:
Performances were filmed in order to be reviewed by three regional anesthesia experts. Participants were then asked to fulfill a questionnaire in another room. This form included a validated task load index grid (NASA) to quantify the amount of stress experienced, demographic data and a realism score.
- Conditions
- Patient Safety, Anesthesia
- Being tested
- Production pressure
- Keywords
- Production pressure, Time pressure
- Medical subject headings
- Time Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Production pressureOther
Participant exposed to production pressure
| Study group | Role | What they receive |
|---|---|---|
| Production pressured environment | Experimental | Participants in this group were exposed to 4 audio recordings applying standardized pressure. Unlimited time. Receives: Other: Production pressure |
| Regular environment | No intervention | The control group was asked to complete the same task also with unlimited time. They were not exposed to the audio recordings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAPS score
Score obtained from regional anesthesia experts using the RAPS assessment tool, a validated tool to measure performance of a regional anesthesia technique (see reference)
Measured: Through scenario completion (approximatively 25 minutes)
Secondary outcomes (2)
Time to complete the task
Time between skin asepsis and needle withdrawal
Measured: Through scenario completion (approximatively 25 minutes)
Stress level experienced
As measured by the NASA task load index, a validated tool to measure mental and physical stress experience during a task.
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 (approximatively 25 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start20 Mar 2021
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, Maisonneuve-Rosemont Hospital
- Responsible party
- Principal investigator, Marie-Eve Belanger, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846660
- Sponsor's protocol ID
- 2021-2533
- Status last verified
- Aug 2021
- First submitted
- 13 Apr 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lessard FO, Tanoubi I, Issa R, Blain J, Belanger ME. Examining the Impact of Time Pressure in Regional Anesthesia: A Prospective Randomized Simulation-Based Study. Anesth Analg. 2026 Nov 1;143(5):1164-1166. doi: 10.1213/ANE.0000000000008108. Epub 2026 May 15. No abstract available.
PubMed 42138972
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Production Pressure in the Regional Anesthesia Block Room on Patient Safety, a Randomized Single Blind Study in a High Fidelity Simulation Environment
- ClinicalTrials.gov ID
- NCT04846660
- Acronym / sponsor ID
- 2021-2533
- Conditions
- Patient Safety, Anesthesia
- Keywords
- Production pressure, Time pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Université de Montréal, Maisonneuve-Rosemont Hospital
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 15 Apr 2021 (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.
This randomized, single blinded simulation based study investigates the impact that production pressure can have on the safety of patients undergoing regional anesthesia. We created a high fidelity scenario where anesthesiologists and trainees were to perform a single shot infraclavicular ultrasound guided block. Participants were randomly assigned to the intervention or control group. Participants assigned to the intervention group were exposed to various production pressure generating interventions. The goal of this study was to look at the impact of production pressure on patient safety by scoring anesthesiologists' and trainees' performance and examining the differences between the two groups.
Detailed description
Sample size:
To our knowledge, no studies were performed to evaluate the impact of production pressure on anesthesiologists nor on how to emulate production pressure in a simulated environment. Although it is known that production pressure affects negatively healthcare workers' performance, it remains difficult to predict its impact on a scoring system such as the RAPS assessment tool. Therefore, we used a convenience sample based on the number of residents and staffs anesthesiologists who agreed to participate. 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 intend to recruit between 10 to 20 participants in each group.
Scenario:
Participants were asked to obtain consent and perform a single shot infraclavicular ultrasound guided block on a 50 year old woman with mild COPD. The simulation took place in situ in a regional anesthesia block room. Upon entering the room, the anesthesiology evaluation was already completed. A CAE infraclavicular block simulator was installed on a simulated patient. A simulated anesthesiology nurse was also present to assist only. All preparation steps and safety measures had to be initiated by the participant. Participants in the intervention group were exposed to 4 standardized pre-recorded audio interventions, encouraging them to proceed faster. The choice of these interventions was based on articles and surveys detailing the common sources of production pressure for the anesthesiologist.
Data collection:
Performances were filmed in order to be reviewed by three regional anesthesia experts. Participants were then asked to fulfill a questionnaire in another room. This form included a validated task load index grid (NASA) to quantify the amount of stress experienced, demographic data and a realism score.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Production pressured environment | Experimental | Other: Production pressureParticipants in this group were exposed to 4 audio recordings applying standardized pressure. Unlimited time. |
| Regular environment | No intervention | –The control group was asked to complete the same task also with unlimited time. They were not exposed to the audio recordings. |
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 performed at least 10 regional anesthesia techniques including 5 infraclavicular blocks
- To consent to the study
Key exclusion criteria (1 listed)
- To refuse to participate
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 |
|---|---|---|
| Production pressureParticipant exposed to production pressure | Other | Production pressured environment |
Primary outcome
RAPS score
Time frame: Through scenario completion (approximatively 25 minutes)
Score obtained from regional anesthesia experts using the RAPS assessment tool, a validated tool to measure performance of a regional anesthesia technique (see reference)
2 secondary outcomes
Time to complete the task
Time frame: Through scenario completion (approximatively 25 minutes)
Stress level experienced
Time frame: Through scenario completion (approximatively 25 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 20 Aug 2021.
- Derived from this study: PubMed 42138972Lessard FO, Tanoubi I, Issa R, Blain J, Belanger ME. Examining the Impact of Time Pressure in Regional Anesthesia: A Prospective Randomized Simulation-Based Study. Anesth Analg. 2026 Nov 1;143(5):1164-1166. doi: 10.1213/ANE.0000000000008108. Epub 2026 May 15. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Production pressure in people with Patient Safety and Anesthesia, run by Ciusss de L'Est de l'Île de Montréal 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 1 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 20 Aug 2021. 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?
RAPS score (time frame: Through scenario completion (approximatively 25 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 NCT04846660, which also lists 1 linked publication.
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 20 Aug 2021.