Trial Outcomes & Findings for Cerebral Oxygenation in Total Hip Arthroplasty Patients (NCT NCT02325154)

NCT ID: NCT02325154

Last Updated: 2024-12-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Intra-operation (when the patient enters the operating room, up to 4 hours)
• Results posted on: 2024-12-27

Participant Flow

Participant milestones

Measure	THA Patients Patients undergoing unilateral total hip arthroplasty Cerebral Oximeter: Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Overall Study STARTED	100
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	THA Patients Patients undergoing unilateral total hip arthroplasty Cerebral Oximeter: Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Overall Study Physician Decision	1

Baseline Characteristics

Cerebral Oxygenation in Total Hip Arthroplasty Patients

Baseline characteristics by cohort

Measure	THA Patients n=99 Participants Patients undergoing unilateral total hip arthroplasty Cerebral Oximeter: Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Age, Continuous	60.6 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Race/Ethnicity, Customized Race Categories · Black or African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Race Categories · White	86 Participants n=5 Participants
Race/Ethnicity, Customized Race Categories · Unknown	9 Participants n=5 Participants
Body Mass Index	28.2 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants

PRIMARY outcome

Timeframe: Intra-operation (when the patient enters the operating room, up to 4 hours)

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.

Outcome measures

Measure	THA Patients n=99 Participants Patients undergoing unilateral total hip arthroplasty Cerebral Oximeter: Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Oxygen Desaturation Incidences	4 Participants

SECONDARY outcome

Timeframe: Intra-op ( during the time the patient is in the operating room, up to 4 hours)

Population: only 4 patients had desaturation events

Duration of cerebral oxygen desaturation

Outcome measures

Measure	THA Patients n=4 Participants Patients undergoing unilateral total hip arthroplasty Cerebral Oximeter: Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Duration of Oxygen Desaturation	11 seconds Interval 5.0 to 120.0

SECONDARY outcome

Timeframe: Post-op Day 1, Post-op Day 2

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.

Outcome measures

Measure	THA Patients n=99 Participants Patients undergoing unilateral total hip arthroplasty Cerebral Oximeter: Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Presence of Post-operative Delirium	0 Participants

SECONDARY outcome

Timeframe: Post-op Day 1, Post-op Day 2

Population: From baseline to POD 1, 7 patients had positive scores in Mini-Cog Test. On POD 2, one patient withdrew from the study, so 6 patients reported positive scores in Mini-Cog test.

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.

Outcome measures

Measure	THA Patients n=99 Participants Patients undergoing unilateral total hip arthroplasty Cerebral Oximeter: Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Patients With Cognitive Dysfunction Post-Operative Day 1 · Abnormal Clock Drawing From baseline	3 Participants
Patients With Cognitive Dysfunction Post-Operative Day 1 · Word Recall decrease From baseline	4 Participants
Patients With Cognitive Dysfunction Post-Operative Day 2 · Abnormal Clock Drawing From baseline	3 Participants
Patients With Cognitive Dysfunction Post-Operative Day 2 · Word Recall decrease From baseline	3 Participants

Adverse Events

THA Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sean Garvin

Hospital for Special Surgery, Anesthesiology

Phone: 2126061036

Email: GarvinS@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place