Sleep Disorders, Circadian Rhythm Clinical Trial
Official title:
The Impact of Night Float on Anesthesiology Resident Sleep Patterns
NCT number | NCT03325244 |
Other study ID # | 11590 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 7, 2017 |
Est. completion date | January 19, 2018 |
Verified date | April 2021 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Residency training requires hospital presence twenty-four hours a day. At times this necessitates working extended shifts, including night shifts, resulting in altered sleep patterns and sleep deprivation. Since 2003, the Accreditation Council for Graduate Medical Education (ACGME) has enforced duty hour regulations limiting shift length, the amount of weekly hours worked, and other variables governing shift work. Numerous studies have sought to determine the impact of duty hour regulations on the quality of patient care and resident education. In addition to affecting patient care, medical resident sleep deprivation also has the potential to affect residents' well-being and their ability to perform basic tasks. A study in surgical residents showed reduced efficiency and safety in performing simulated laparoscopy following a period of sleep deprivation that was worse with novices compared to experienced residents. Recently, UVA found that resident physicians have greater difficulty controlling speed and driving performance with increased reaction times and minor and major lapses in attention in the driving simulator following six consecutive night shifts. To comply with duty hour restrictions, residency programs have adopted various strategies including the creation of night float systems where residents are required to work multiple nights in a row. Reduced shift length has been associated with decreased medical errors, motor vehicle collisions, and percutaneous injuries.Surgical residents who transitioned to a night float system from 24-hour call every 3rd day reported reduced fatigue, more time for sleep and independent reading and increased family time, while nurses and patients reported improved communication and quality of patient care. In a pilot study of urology residents assigned to a 12-hour day shift (Monday-Friday), 12-hour night float (Sunday-Friday) or 24-hour home call, actigraphy was used to measure total sleep time, sleep latency and depth of sleep. Night float did not impact total sleep time or quality of sleep. However, these studies did not establish the optimal shift duration
Status | Completed |
Enrollment | 20 |
Est. completion date | January 19, 2018 |
Est. primary completion date | January 19, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - postgraduate year (PGY) 2, 3, and 4 Anesthesia residents Exclusion Criteria: - history of pacemaker or other medical device - unable or unwilling to consent and comply with the protocol - history of sleep disorder |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Health System | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Ayas NT, Barger LK, Cade BE, Hashimoto DM, Rosner B, Cronin JW, Speizer FE, Czeisler CA. Extended work duration and the risk of self-reported percutaneous injuries in interns. JAMA. 2006 Sep 6;296(9):1055-62. — View Citation
Barger LK, Cade BE, Ayas NT, Cronin JW, Rosner B, Speizer FE, Czeisler CA; Harvard Work Hours, Health, and Safety Group. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005 Jan 13;352(2):125-34. — View Citation
Goldstein MJ, Kim E, Widmann WD, Hardy MA. A 360 degrees evaluation of a night-float system for general surgery: a response to mandated work-hours reduction. Curr Surg. 2004 Sep-Oct;61(5):445-51. — View Citation
Huffmyer JL, Moncrief M, Tashjian JA, Kleiman AM, Scalzo DC, Cox DJ, Nemergut EC. Driving Performance of Residents after Six Consecutive Overnight Work Shifts. Anesthesiology. 2016 Jun;124(6):1396-403. doi: 10.1097/ALN.0000000000001104. — View Citation
Ko JS, Readal N, Ball MW, Han M, Pierorazio PM. Call Schedule and Sleep Patterns of Urology Residents Following the 2011 ACGME Reforms. Urol Pract. 2016 Mar;3(2):147-152. — View Citation
Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA. Effect of reducing interns' work hours on serious medical errors in intensive care units. N Engl J Med. 2004 Oct 28;351(18):1838-48. — View Citation
Philibert I, Nasca T, Brigham T, Shapiro J. Duty-hour limits and patient care and resident outcomes: can high-quality studies offer insight into complex relationships? Annu Rev Med. 2013;64:467-83. doi: 10.1146/annurev-med-120711-135717. Epub 2012 Oct 26. Review. — View Citation
Reed DA, Fletcher KE, Arora VM. Systematic review: association of shift length, protected sleep time, and night float with patient care, residents' health, and education. Ann Intern Med. 2010 Dec 21;153(12):829-42. doi: 10.7326/0003-4819-153-12-201012210-00010. Review. — View Citation
Sen S, Kranzler HR, Didwania AK, Schwartz AC, Amarnath S, Kolars JC, Dalack GW, Nichols B, Guille C. Effects of the 2011 duty hour reforms on interns and their patients: a prospective longitudinal cohort study. JAMA Intern Med. 2013 Apr 22;173(8):657-62; discussion 663. doi: 10.1001/jamainternmed.2013.351. — View Citation
Tsafrir Z, Korianski J, Almog B, Many A, Wiesel O, Levin I. Effects of Fatigue on Residents' Performance in Laparoscopy. J Am Coll Surg. 2015 Aug;221(2):564-70.e3. doi: 10.1016/j.jamcollsurg.2015.02.024. Epub 2015 Mar 4. — View Citation
Wang Y, Loparo KA, Kelly MR, Kaplan RF. Evaluation of an automated single-channel sleep staging algorithm. Nat Sci Sleep. 2015 Sep 18;7:101-11. doi: 10.2147/NSS.S77888. eCollection 2015. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | sleep time | total sleep time as measured by EEG monitor | daily over 13 day period (Day 1 -Day 12) | |
Secondary | activity level | • as measured by activity monitor | daily over 13 day period (Day 1-Day 12) |
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