An interventional study of Cerebral Oximeter in Cerebral Oxygen Desaturation and Post-operative Delirium, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Other
We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.
The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 491 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
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Exclusion Criteria:
Non-English Speaking*
Patients undergoing unilateral total hip arthroplasty
Device: Cerebral Oximeter
Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Also known as: oximeter
Oxygen Desaturation Incidences
The number of participant's experiencing an intra-operative cerebral oxygen desaturation event. Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours.
Time frame: Intra-operation (when the patient enters the operating room, up to 4 hours)
Duration of Oxygen Desaturation
Duration of cerebral oxygen desaturation
Time frame: Intra-op ( during the time the patient is in the operating room, up to 4 hours)
Presence of Post-operative Delirium
The number of patients who have post-operative delirium, as determined by counting the patients who suffer from this condition. Although recorded at various time points, the total number of participants experiencing post-operative delirium was summed and reported.
Time frame: Post-op Day 1, Post-op Day 2
Patients With Cognitive Dysfunction
The number of patients considered to experience cognitive dysfunction as identified by low scores on the mini-Cog. The Mini-Cog checks for the brain function (or the cognitive impairment) of the participant. The Mini-Cog does this by examining a patient's ability in two areas. This is done via a three-word recall test and the Clock Drawing Test. 1. Three-Word Recall 2. The Clock Drawing Test (CDT) There are five total points a person can score on the Mini-Cog: * Give one point for each word that was correctly remembered. (0-3 points) * Give two points for a correctly drawn clock, meaning the numbers are in roughly the correct locations and two hands are pointed to the 11 and the 2. The length of the hands does not matter. (0 or 2 points) If a patient scores less than three points, they are counted as experiencing cognitive dysfunction. Although collected across different time points, the total number of patients scoring less than 3 points were summed and reported.
Time frame: Post-op Day 1, Post-op Day 2
| Milestone | THA Patients |
|---|---|
| Started | 100 |
| Completed | 99 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
The number of participant's experiencing an intra-operative cerebral oxygen desaturation event. Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours.
| Participants | THA Patients |
|---|---|
| Oxygen Desaturation Incidences | 4 |
Duration of cerebral oxygen desaturation
| seconds | THA Patients |
|---|---|
| Duration of Oxygen Desaturation | 11 (5 to 120) |
The number of patients who have post-operative delirium, as determined by counting the patients who suffer from this condition. Although recorded at various time points, the total number of participants experiencing post-operative delirium was summed and reported.
| Participants | THA Patients |
|---|---|
| Presence of Post-operative Delirium | 0 |
The number of patients considered to experience cognitive dysfunction as identified by low scores on the mini-Cog. The Mini-Cog checks for the brain function (or the cognitive impairment) of the participant. The Mini-Cog does this by examining a patient's ability in two areas. This is done via a three-word recall test and the Clock Drawing Test. 1. Three-Word Recall 2. The Clock Drawing Test (CDT) There are five total points a person can score on the Mini-Cog: * Give one point for each word that was correctly remembered. (0-3 points) * Give two points for a correctly drawn clock, meaning the numbers are in roughly the correct locations and two hands are pointed to the 11 and the 2. The length of the hands does not matter. (0 or 2 points) If a patient scores less than three points, they are counted as experiencing cognitive dysfunction. Although collected across different time points, the total number of patients scoring less than 3 points were summed and reported.
| Participants | THA Patients |
|---|---|
| Post-Operative Day 1 — Abnormal Clock Drawing From baseline | 3 |
| Post-Operative Day 1 — Word Recall decrease From baseline | 4 |
| Post-Operative Day 2 — Abnormal Clock Drawing From baseline | 3 |
| Post-Operative Day 2 — Word Recall decrease From baseline | 3 |
Collected over up to 2 days following surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| THA Patients | 0/99 (0%) | 0/99 (0%) | 0/99 (0%) |
| Age, Continuous(years) | THA Patients |
|---|---|
| Mean | 60.6 ± 9.9 |
| Sex: Female, Male(Participants) | THA Patients |
|---|---|
| Female | 52 |
| Male | 47 |
| Race/Ethnicity, Customized(Participants) | THA Patients |
|---|---|
| Race Categories — Black or African American | 4 |
| Race Categories — White | 86 |
| Race Categories — Unknown | 9 |
| Body Mass Index(kg/m^2) | THA Patients |
|---|---|
| Mean | 28.2 ± 5.4 |
The record gives a start of Dec 2014, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2023, 6 years 7 months after primary completion.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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