Injury as a Result of PositioningBCPNCT02674334
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
A study testing NIRS and NIRS monitored not treated in people with Injury as a Result of Positioning, run by West Virginia University at 1 site in United States.
Trial summary
The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Injury as a Result of Positioning
- What is being tested?
- NIRS and NIRS monitored not treated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- elective shoulder surgery in the beach chair position
Who cannot join
- less than 18 years of age
- preoperative score of 23 or less on the pre-operative Mini Mental State Exam
- traumatic brain injury
- transient ischemic attack
- cerebrovascular incident
- any apparent clinical neurologic dysfunction
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- carotid artery stenosis
- known vascular malformation in head
- inability to have blood pressure measured in the opposite extremity
- malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506-9196
About this study
The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.
Read the detailed description
In this prospective, randomized, controlled study, investigators used a standardized anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia management and would not affect the post-operative cognitive outcomes of participants undergoing surgery in the beach chair position. Investigators secondarily wanted to document the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in participants placed in the BCP if the MAP was strictly maintained.
- Conditions
- Injury as a Result of Positioning
- Being tested
- NIRS, NIRS monitored not treated
- Keywords
- orthopedic procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
Also called Near infrared spectroscopy
Near infrared spectroscopy (NIRS) monitor allows anesthesiologist to treat cerebral desaturations according to NIRS results while maintaining Mean Arterial Pressure (MAP) at least 60mmHG or at least 80% of baseline
NIRS monitored not treatedDevice
Also called Near infrared spectroscopy
Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.
| Study group | Role | What they receive |
|---|---|---|
| NIRS Monitored Not Treated | Active comparator | Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS) Receives: Device: NIRS monitored not treated |
| NIRS Monitored and Treated | Active comparator | Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS) Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With 20+% Cerebral Desaturation Events
Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position
Measured: one day
Secondary outcomes (1)
Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value
Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) > 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value.
Measured: baseline and up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Injury as a Result of PositioningStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George K Bal, West Virginia University
- Investigators
- George K Bal, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674334
- Sponsor's protocol ID
- 1409418786
- Acronym
- BCP
- Status last verified
- Aug 2017
- First submitted
- 10 Dec 2015
- Last updated
- 11 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Only group data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
- ClinicalTrials.gov ID
- NCT02674334
- Acronym / sponsor ID
- BCP / 1409418786
- Conditions
- Injury as a Result of Positioning
- Keywords
- orthopedic procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 11 Sep 2017
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 this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.
Detailed description
In this prospective, randomized, controlled study, investigators used a standardized anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia management and would not affect the post-operative cognitive outcomes of participants undergoing surgery in the beach chair position. Investigators secondarily wanted to document the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in participants placed in the BCP if the MAP was strictly maintained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIRS Monitored Not Treated | Active comparator | Device: NIRS monitored not treatedAnesthesiologist blinded to Near Infrared Spectroscopy (NIRS) |
| NIRS Monitored and Treated | Active comparator | Device: NIRSAnesthesiologist treats based on Near Infrared Spectroscopy (NIRS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years of age
- elective shoulder surgery in the beach chair position
Key exclusion criteria (10 listed)
- less than 18 years of age
- preoperative score of 23 or less on the pre-operative Mini Mental State Exam
- traumatic brain injury
- transient ischemic attack
- cerebrovascular incident
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 |
|---|---|---|
| NIRSAlso: Near infrared spectroscopyNear infrared spectroscopy (NIRS) monitor allows anesthesiologist to treat cerebral desaturations according to NIRS results while maintaining Mean Arterial Pressure (MAP) at least 60mmHG or at least 80% of baseline | Device | NIRS Monitored and Treated |
| NIRS monitored not treatedAlso: Near infrared spectroscopyNear infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care. | Device | NIRS Monitored Not Treated |
Primary outcome
Percentage of Participants With 20+% Cerebral Desaturation Events
Time frame: one day
Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position
1 secondary outcome
Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value
Time frame: baseline and up to two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only group data will be available.
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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.
George K Bal, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS and NIRS monitored not treated in people with Injury as a Result of Positioning, run by West Virginia University 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 10 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 11 Sep 2017. 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?
Yes. Results are posted in the registry (first posted 11 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With 20+% Cerebral Desaturation Events (time frame: one day). 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 11 Sep 2017.