Disturbing Factors in the Operating Room

NCT03163537 | Completed FDA Device

• 1 other identifier: HEEL-2016-01
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Observation of disturbing factors in the operating room and comparison between day and night shift. The investigators have chosen to observe kidney transplantations, since this type of operation has the same priority during day and night. Stress levels of surgeons will be measured using the HealthPatch.

Conditions

Disturbing Factors; Stress

Outcome Measures

Primary Outcomes (1)

• Factors that are disturbing for vascular surgeons during kidney transplantations

  One investigator will report all factors that potentially disturb the vascular surgeon during kidney transplantation. Nature and severity of the disturbing factors will be reported, such as opening and closing of doors, beepers. For this, the investigators will use an observational tool for assessing surgical flow disruptions (Parker SE, et al. Development and evaluation of an observational tool for assessing surgical flow disruptions and their impact on surgical performance. World J Surg 2010; 34(2): 353-361)

  2 hours

Secondary Outcomes (2)

• Stress levels

  2 hours

• State Trait Anxiety Inventory

  5 minutes

Study Arms (3)

Kidney transplantation, postmortal, day

Device: HealthPatch

Kidney transplantation, postmortal, night

Device: HealthPatch

Kidney transplantation, living donor

Device: HealthPatch

Interventions

HealthPatch DEVICE

Smart patch that is able to measure stress real time using an algorithm between HR and HRV

Kidney transplantation, living donor; Kidney transplantation, postmortal, day; Kidney transplantation, postmortal, night

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Vascular surgeons during kidney transplantation

You may qualify if:

• All vascular surgeons who are able to perform elective as well as postmoral kidney transplantations

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 23, 2017
• Study Start: July 1, 2016
• Primary Completion: May 12, 2017
• Study Completion: May 13, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05