NCT02354755

Brief 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). Reaction times will be measured via a 10-minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

January 29, 2015

Last Update Submit

January 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    10 minutes

Secondary Outcomes (1)

  • SurveyMonkey Questionairre

    10 minutes

Study Arms (3)

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

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

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

Device: Psychomotor vigilance test (PVT

Interventions

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).

Cold roomControl RoomHot room

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Physicians in training (Anesthesiology/surgery residents, fellows and certified registered nurse anesthetists.

You may qualify if:

  • CRNA or surgery or anesthesiology resident fellow in ongoing surgery case

You may not qualify if:

  • unwilling to participate
  • any clinical circumstance that precludes participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 3, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01