Physiological StressNCT06180044
Physiologic Burden to the Surgeon During Orthopaedic Surgery
An observational study of Physiological Stress, run by University of Utah at 1 site in United States.
Trial summary
The investigator's plan to quantify the physiologic impact of orthopaedic surgery on the surgeon and operating team. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Physiological Stress
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 3 Aug 2026
- 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Orthopaedic surgeons, orthopaedic fellows, and orthopaedic residents performing surgery.
Who may be able to join
- Orthopaedic surgeons, orthaopedic fellows, and orthopaedic residents.
- Up to 750 surgical patients of the participating surgeons will be included for demographic chart review.
Who cannot join
- Non-surgeons, fellows, or residents.
- Female participants that are or become pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: Quantification of Physiologic Burden to the Surgeon During Orthopaedic Surgery
The investigator's plan to quantify the physiologic impact of orthopaedic surgery on the surgeon and operating team.
Read the detailed description
The prevalence of musculoskeletal pain among orthopaedic surgeons is inordinately high. Poor surgical ergonomics and physiological stress have been shown to impair surgical performance and cause injuries. Various approaches, techniques and instruments have been designed to improve surgical outcomes for patients. There has been nominal research in the area of occupational hazards such surgeries impose upon the surgeon. Several studies have demonstrated a higher risk of cervical spondylosis and rotator cuff tears amongst surgeons. However, little has been studied on the impacts of some of these approaches, techniques, and instruments on surgeons' physiologic measures.
The investigator's will use The Hexoskin Smart Vest to capture physiological data from surgeons during the study.
- Conditions
- Physiological Stress
- Keywords
- Surgeon, Orthopaedic surgery, Hexoskin Smart Vest, Physiologic data
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Heart Rate (beats per minute, bpm)
Average surgeon heart rate prior to surgery.
Measured: 30 minutes before surgery
Average Heart Rate (beats per minute, bpm)
Average surgeon heart rate during surgery.
Measured: During entire surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start28 Nov 2023
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pelt, University of Utah
- Investigators
- Christopher Pelt, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180044
- Sponsor's protocol ID
- 170873
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Physiologic Burden to the Surgeon During Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT06180044
- Acronym / sponsor ID
- 170873
- Conditions
- Physiological Stress
- Keywords
- Surgeon, Orthopaedic surgery, Hexoskin Smart Vest, Physiologic data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 22 Dec 2023 (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.
The investigator's plan to quantify the physiologic impact of orthopaedic surgery on the surgeon and operating team.
Detailed description
The prevalence of musculoskeletal pain among orthopaedic surgeons is inordinately high. Poor surgical ergonomics and physiological stress have been shown to impair surgical performance and cause injuries. Various approaches, techniques and instruments have been designed to improve surgical outcomes for patients. There has been nominal research in the area of occupational hazards such surgeries impose upon the surgeon. Several studies have demonstrated a higher risk of cervical spondylosis and rotator cuff tears amongst surgeons. However, little has been studied on the impacts of some of these approaches, techniques, and instruments on surgeons' physiologic measures.
The investigator's will use The Hexoskin Smart Vest to capture physiological data from surgeons during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Orthopaedic surgeons, orthopaedic fellows, and orthopaedic residents performing surgery.
Key inclusion criteria (2 listed)
- Orthopaedic surgeons, orthaopedic fellows, and orthopaedic residents.
- Up to 750 surgical patients of the participating surgeons will be included for demographic chart review.
Key exclusion criteria (2 listed)
- Non-surgeons, fellows, or residents.
- Female participants that are or become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average Heart Rate (beats per minute, bpm)
Time frame: 30 minutes before surgery
Average surgeon heart rate prior to surgery.
Average Heart Rate (beats per minute, bpm)
Time frame: During entire surgical procedure
Average surgeon heart rate during surgery.
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 7 Aug 2026.
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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.
Christopher Pelt, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiological Stress, run by University of Utah at 1 site in United States.
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 2 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 7 Aug 2026. 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 United States. 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?
Average Heart Rate (beats per minute, bpm) (time frame: 30 minutes before surgery). The study lists 2 primary outcomes in all. 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 7 Aug 2026.