Trial Outcomes & Findings for Observational Examination of Thermoregulation in Total Joint Arthroplasty (NCT NCT02225743)

NCT ID: NCT02225743

Last Updated: 2019-01-24

Results Overview

The incidence of ever being hypothermic (temperature \< 36.0 °C at one or more measurements) was the primary outcome. All temperatures were assessed with an Exergen temporal thermometer (precise to 0.1 °C). Each temporal measurement was taken and recorded three times for accuracy and the mean value utilized for data analysis at each time point. Temperatures were measured upon (1) leaving holding area; (2) operating room (OR) arrival; (3) after anesthetic induction; (4) upper body forced air warmer initiation (used for all patients); (5) incision; (6-8) every 30 minutes after incision; (9) leaving the OR; and (10) arrival to PACU. OR temperature and humidity were recorded throughout.

• Recruitment status: COMPLETED
• Target enrollment: 120 participants
• Primary outcome timeframe: Starting with temperature measurement prior to leaving preoperative holding for OR and ending after temperature taken on arrival in recovery room
• Results posted on: 2019-01-24

Participant Flow

Participant milestones

Measure	Joint Arthroplasty Participants undergoing joint replacement Observation Of Temperature: Participants temperature will be recorded perioperatively.
Overall Study STARTED	120
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	Joint Arthroplasty Participants undergoing joint replacement Observation Of Temperature: Participants temperature will be recorded perioperatively.
Overall Study Withdrawal by Subject	18

Baseline Characteristics

Observational Examination of Thermoregulation in Total Joint Arthroplasty

Baseline characteristics by cohort

Measure	Joint Arthroplasty n=102 Participants Participants undergoing joint replacement Observation Of Temperature: Participants temperature will be recorded perioperatively.
Age, Continuous	63.5 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Total Knee Arthroplasty	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: Starting with temperature measurement prior to leaving preoperative holding for OR and ending after temperature taken on arrival in recovery room

Population: Ever hypothermic (temperature \<36.0 degrees C) during the perioperative period

The incidence of ever being hypothermic (temperature < 36.0 °C at one or more measurements) was the primary outcome. All temperatures were assessed with an Exergen temporal thermometer (precise to 0.1 °C). Each temporal measurement was taken and recorded three times for accuracy and the mean value utilized for data analysis at each time point. Temperatures were measured upon (1) leaving holding area; (2) operating room (OR) arrival; (3) after anesthetic induction; (4) upper body forced air warmer initiation (used for all patients); (5) incision; (6-8) every 30 minutes after incision; (9) leaving the OR; and (10) arrival to PACU. OR temperature and humidity were recorded throughout.

Outcome measures

Measure	Hypothermia n=102 Participants Hypothermia was defined as a temperature less than 36.0 °C. .
Incidence of Hypothermia	74 Participants

Adverse Events

Joint Arthroplasty

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

Sylvia Wilson, MD

Medical University of South Carolina

Phone: 843-792-2322

Email: wilsosh@musc.edu

Results disclosure agreements

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