Anesthesia ProvidersNCT02354755
The Effect of Temperature on Anesthesia and Surgical Resident's Ability to Perform Clinical and Cognitive Tasks
An observational study of Anesthesia Providers, run by Vidya Raman.
Trial summary
The purpose of the current study is to examine whether changes in intraoperative ambient temperature has in impact on the clinical performance of the physicians in training which include Anesthesiology and Surgical residents, fellows and certified nurse anesthetists (CRNA). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Providers
- What is being tested?
- Psychomotor vigilance test (PVT
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2017
- Phase
- Observational
- 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
Study population: Physicians in training (Anesthesiology/surgery residents, fellows and certified registered nurse anesthetists.
Who may be able to join
- CRNA or surgery or anesthesiology resident fellow in ongoing surgery case
Who cannot join
- unwilling to participate
- any clinical circumstance that precludes participation
About this study
The purpose of the current study is to examine whether changes in intraoperative ambient temperature has in impact on the clinical performance of the physicians in training which include Anesthesiology and Surgical residents, fellows and certified nurse anesthetists (CRNA). Reaction times will be measured via a 10-minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device.
- Conditions
- Anesthesia Providers
- Being tested
- Psychomotor vigilance test (PVT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychomotor vigilance test (PVTDevice
The Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurements. The device measures the speed with which subject responds to visual stimulus (by pressing a response button).
| Study group | Role | What they receive |
|---|---|---|
| Cold room | Anesthesia providers intraoperatively placed in ambient room temperature of 65 degreees (cold room), completing a 10-minute psychomotor vigilance test (PVT), followed up by a questionnaire on SurveyMonkey Receives: Device: Psychomotor vigilance test (PVT | |
| Hot room | Anesthesia providers intraoperatively placed in ambient room temperature of 80 degreees (hot room), completing a 10-minute psychomotor vigilance test (PVT), followed up by a questionnaire on SurveyMonkey Receives: Device: Psychomotor vigilance test (PVT | |
| Control Room | as a control placed Anesthesia providers in ambient room temperature of 75 degreees (neutral room), completing a 10-minute psychomotor vigilance test (PVT), followed up by a questionnaire on SurveyMonkey Receives: Device: Psychomotor vigilance test (PVT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor vigilance test
The Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurements. The device measures the speed with which subject responds to visual stimulus (by pressing a response button).
Measured: 10 minutes
Secondary outcomes (1)
SurveyMonkey Questionairre
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia ProvidersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidya Raman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vidya Raman, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354755
- Sponsor's protocol ID
- IRB14-00858
- Status last verified
- Jan 2017
- First submitted
- 29 Jan 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Temperature on Anesthesia and Surgical Resident's Ability to Perform Clinical and Cognitive Tasks
- ClinicalTrials.gov ID
- NCT02354755
- Acronym / sponsor ID
- IRB14-00858
- Conditions
- Anesthesia Providers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vidya RamanUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 3 Feb 2015 (estimated)
- 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 purpose of the current study is to examine whether changes in intraoperative ambient temperature has in impact on the clinical performance of the physicians in training which include Anesthesiology and Surgical residents, fellows and certified nurse anesthetists (CRNA). Reaction times will be measured via a 10-minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cold room | – | Device: Psychomotor vigilance test (PVTAnesthesia providers intraoperatively placed in ambient room temperature of 65 degreees (cold room), completing a 10-minute psychomotor vigilance test (PVT), followed up by a questionnaire on SurveyMonkey |
| Hot room | – | Device: Psychomotor vigilance test (PVTAnesthesia providers intraoperatively placed in ambient room temperature of 80 degreees (hot room), completing a 10-minute psychomotor vigilance test (PVT), followed up by a questionnaire on SurveyMonkey |
| Control Room | – | Device: Psychomotor vigilance test (PVTas a control placed Anesthesia providers in ambient room temperature of 75 degreees (neutral room), completing a 10-minute psychomotor vigilance test (PVT), followed up by a questionnaire on SurveyMonkey |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians in training (Anesthesiology/surgery residents, fellows and certified registered nurse anesthetists.
Key inclusion criteria (1 listed)
- CRNA or surgery or anesthesiology resident fellow in ongoing surgery case
Key exclusion criteria (2 listed)
- unwilling to participate
- any clinical circumstance that precludes participation
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 |
|---|---|---|
| Psychomotor vigilance test (PVTThe Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurements. The device measures the speed with which subject responds to visual stimulus (by pressing a response button). | Device | Cold room, Control Room, Hot room |
Primary outcome
Psychomotor vigilance test
Time frame: 10 minutes
The Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurements. The device measures the speed with which subject responds to visual stimulus (by pressing a response button).
1 secondary outcome
SurveyMonkey Questionairre
Time frame: 10 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 31 Jan 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Providers, run by Vidya Raman.
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 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Psychomotor vigilance test (time frame: 10 minutes). 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 31 Jan 2017.