Trial Outcomes & Findings for Total Shoulder Arthroplasty Near-infrared Spectroscopy (NCT NCT02198183)

Results Overview

The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of \>20% from baseline that lasts for 90 seconds or longer.

Recruitment status

COMPLETED

Target enrollment

34 participants

Primary outcome timeframe

Day of surgery

Results posted on

2023-01-17

Participant Flow

Participant milestones

Participant milestones
Measure	Near-infrared Spectroscopy Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
Overall Study STARTED	34
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Total Shoulder Arthroplasty Near-infrared Spectroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Near-infrared Spectroscopy n=25 Participants Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	17 Participants n=99 Participants
Age, Continuous	67 years STANDARD_DEVIATION 8 • n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	14 Participants n=99 Participants
Region of Enrollment United States	25 participants n=99 Participants

PRIMARY outcome

Timeframe: Day of surgery

The number of Cerebral Desaturation Events (CDE) that occured. CDE is defined as a reduction in cerebral tissue oxygen saturation of \>20% from baseline that lasts for 90 seconds or longer.

Outcome measures

Outcome measures
Measure	Near-infrared Spectroscopy n=25 Participants Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
Number of Cerebral Desaturation Events	0 Number of CDE Incidences

SECONDARY outcome

Timeframe: Day of surgery

Cardiac output of patients as measured in liters per minute

Outcome measures

Outcome measures
Measure	Near-infrared Spectroscopy n=25 Participants Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
Cardiac Output (CO)	5.6 liters per minute Standard Deviation 1.2

SECONDARY outcome

Timeframe: Day of surgery

Average cardiac index for patients, a measurement of how efficient the heart is pumping. Measured in liters per minute per meters squared of heart size.

Outcome measures

Outcome measures
Measure	Near-infrared Spectroscopy n=25 Participants Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
Cardiac Index (CI)	3 L/min/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: Day of surgery

Stroke volume, the amount of blood pumped by the left ventricle of the heart with each contraction. Measured in milliliters.

Outcome measures

Outcome measures
Measure	Near-infrared Spectroscopy n=25 Participants Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
Stroke Volume (SV)	74 milliliters Standard Deviation 11

SECONDARY outcome

Timeframe: Day of surgery

mean arterial pressure and noninvasive blood pressure will be represented as a percentage of baseline after surgery. A lower percentage is a worse outcome.

Outcome measures

Outcome measures
Measure	Near-infrared Spectroscopy n=25 Participants Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
Mean Arterial Pressure (MAP) GA without PPV	76 percent Standard Deviation 15
Mean Arterial Pressure (MAP) GA with PPV	67 percent Standard Deviation 17

SECONDARY outcome

Timeframe: Day of surgery

a lower score is a better outcome.

Outcome measures

Outcome measures
Measure	Near-infrared Spectroscopy n=25 Participants Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
End Tidal Carbon Dioxide (ETCO2) GA without PPV	44 mmHg Standard Deviation 5
End Tidal Carbon Dioxide (ETCO2) GA with PPV	45 mmHg Standard Deviation 6

SECONDARY outcome

Timeframe: Day of surgery

Outcome measures

Outcome measures
Measure	Near-infrared Spectroscopy n=25 Participants Casmed Fore-Sight Elite and Non-invasive Cardiac Output Monitor (NICOM) Casmed Fore-Sight Elite Non-invasive Cardiac Output Monitor (NICOM)
Intravenous Fluid Volume	1408 mL Standard Deviation 227

Adverse Events

Near-infrared Spectroscopy

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 Jacques Yadeau

Hospital for Special Surgery, Anesthesiology

Phone: 2126061036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place