Cerebral Perfusion in the Beach Chair Position

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-25

Study Completion Date

2020-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Surgery to the shoulder may be performed with patients seated upright in a position known as the "Beach Chair Position (BCP)." This position has certain advantages compared to alternative surgical positions (e.g. side lying) in some situations. However, it has been found that surgery in the BCP can temporarily decrease the amount of oxygen in the brain as a result of the combined effects of gravity and anaesthesia. This can result in complications following surgery such as some memory loss and confusion. Rarely, more serious complications have been reported in the past including death and stroke.

Due to these reported complications the use of "cerebral oximetry" during shoulder surgery in the BCP has become more common. Before and during surgery, a monitor placed on the patients forehead measures the amount of oxygen present in the brain to help control this to an acceptable level. A number of monitors are now commercially available. Two monitors are commonly discussed in the literature; the INVOS™ 5100 and the FORE-SIGHT® machines. However, the actual relationship between the supply of oxygen to the brain during surgery and the chance of later developing problems with memory and thinking (known as "post operative cognitive decline" - POCD) is not clear. It is also not known if one monitor is more accurate than another at predicting these complications.

Therefore, the main aim of this study is to examine the relationship between cerebral oxygen levels during shoulder surgery and the incidence of POCD (i.e. problems with memory and thinking). A second aim is to compare the INVOS™ 5100 and FORE-SIGHT® monitors ability to measure cerebral oxygen and cerebral desaturation events (CDEs) as well as the importance of other key clinical variables (e.g. blood pressure, nausea, body fat etc).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

NCT01546636

Cerebral Ischemia

COMPLETED NA

Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position

NCT01535274

Stroke

COMPLETED NA

Ventilatory Influence on Cerebral Oxygenation During VATS

NCT05033353

Thoracic Diseases

COMPLETED NA

Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position

NCT06378710

Surgery

RECRUITING NA

Physiological Studies in the Prone Position in Patients With ARDS

NCT06586736

Acute Respiratory Distress Syndrome Mechanical Ventilation Prone Positioning

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PURPOSE OF THE INVESTIGATION The purpose of this investigation is to generate evidence about cerebral oxygenation during shoulder surgery and the incidence of POCD. Currently, evidence relating to POCD following surgery is conflicting and relates mostly to outcomes following cardiac surgery. There is a strong need to explore this relationship in the specific context of shoulder surgery in the BCP.

INTERVENTION GROUPS This study will involve a single prospective cohort. Patients who meet the selection criteria will be recruited to the study following voluntary informed consent . Cerebral oxygenation will be measured by application of cerebral oximeters to each patients forehead.

AIM OF THE STUDY This study has three aims; (i) To examine the relationship between cerebral desaturation during shoulder surgery in the BCP, and the incidence of POCD.

(ii) To determine the variation in cerebral oxygenation recorded using randomised (for superior/inferior) simultaneous application of the INVOS™ and FORE-SIGHT® oximeters, during shoulder surgery in the beach chair position.

(iii) Assess the relationships between cerebral oxygen desaturation during shoulder surgery in the BCP and variables including mean arterial pressure, incidence of nausea/vomiting, duration of hospital stay, BMI, hypertension and adverse events.

RESEARCH QUESTION There are three research questions correlating with the three research aims; (i) Is cerebral desaturation during shoulder surgery associated with POCD? (ii) Do the FORE-SIGHT® and INVOS™ 5100 devices vary in their measurement of cerebral oxygenation during shoulder surgery in the BCP? (iii) Is there a relationship between cerebral desaturation events during shoulder surgery in the BCP and variables including mean arterial blood pressure, post-operative nausea/vomiting, length of hospital stay, BMI, hypertension and any adverse events?

NULL HYPOTHESES The three null hypotheses are; (i) Cerebral desaturation as measured using cerebral oximetry is not related to POCD after shoulder surgery in the BCP.

(ii) There is no significant difference between the INVOS™ 5100 and the FORE-SIGHT® monitors assessment of cerebral oxygenation during shoulder surgery in the BCP.

(iii) There is no relationship between cerebral desaturation events during shoulder surgery in the BCP and variables including mean arterial blood pressure, the frequency of post-operative nausea/vomiting, length of hospital stay, BMI, hypertension and any adverse events.

PRIMARY HYPOTHESES The primary research hypotheses are; (i) Cerebral desaturation events during surgery in the BCP will be related to POCD.

(ii) The INVOS™ 5100 and the FORE-SIGHT® monitors will show no significant difference in their ability to measure cerebral oxygenation.

(iii) Cerebral desaturation events experienced during shoulder surgery in the BCP are related to a drop in mean arterial blood pressure, an increased likelihood of post-operative nausea and vomiting, greater length of hospital stay, a higher BMI, hypertension and greater frequency of adverse events.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgery patients

Patients receiving shoulder surgery in the Beach Chair Position, and monitored by both INVOS and FORE-SIGHT monitors.

Group Type EXPERIMENTAL

Dual-monitoring

Intervention Type DEVICE

Monitored using both INVOS and FORE-SIGHT monitors.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dual-monitoring

Monitored using both INVOS and FORE-SIGHT monitors.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Receiving treatment primarily by, but not restricted to, one of the Primary investigators for a shoulder condition that requires surgery in the BCP.
* Over 18 years of age
* Able to read and speak English

Exclusion Criteria

* Under 18 years of age
* Pregnant women
* Pre-operative Mini-Mental State Examination (MMSE) \< 24
* Pre-existing cerebrovascular disease as reported by the assessing medical consultant and recorded in patient charts
* Orthostatic hypotension
* American Society of Anaesthesiologists (ASA) physical status III, IV and V\*
* History of drug and/or alcohol abuse
* Neurological disease (e.g. previous stroke)
* Significant mood and anxiety disorders as determined by treating consultant.
* Any other condition, which in the opinion of the investigators, would render the patient unsuitable for participation in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No