Observational Examination of Thermoregulation in Total Joint Arthroplasty

NCT02225743 | Completed Results

• 2 other identifiers: Thermoregulation Total JointPro00035290
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Total joint patients have poor outcomes with infection since they are having permanent hardware implanted. Infection prevention in this group is therefore critical and a major source of discussion in both the orthopedic and anesthesia literature. Hypothermia has been shown to increase the risk of infection and blood loss. However, studies have not examined when in the operation or how fast patients temperatures drop. This study will observe how patients' temperatures change during total joint arthroplasty. By identifying when body temperature changes occur, prevention strategies may be developed and implemented.

Conditions

Hypothermia

Keywords

Hypothermia; Total Hip Joint Prosthesis; Total Knee Joint Prosthesis

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypothermia

  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.

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

Study Arms (1)

Joint Arthroplasty

Participants undergoing joint replacement

Other: Observation Of Temperature

Interventions

Observation Of Temperature OTHER

Participants temperature will be recorded perioperatively.

Joint Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults 18 years or older that are having a total joint replacement surgery.

You may qualify if:

• Adults 18 years of age and over that are scheduled to undergo total hip or total knee joint arthroplasty.

You may not qualify if:

• Patients unable to give informed consent will be excluded.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (4)

• Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. doi: 10.1016/j.bpa.2007.10.004.

  PMID: 18494388 BACKGROUND

• Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.

  PMID: 8606715 BACKGROUND

• Seamon MJ, Wobb J, Gaughan JP, Kulp H, Kamel I, Dempsey DT. The effects of intraoperative hypothermia on surgical site infection: an analysis of 524 trauma laparotomies. Ann Surg. 2012 Apr;255(4):789-95. doi: 10.1097/SLA.0b013e31824b7e35.

  PMID: 22388109 BACKGROUND

• Sun Z, Honar H, Sessler DI, Dalton JE, Yang D, Panjasawatwong K, Deroee AF, Salmasi V, Saager L, Kurz A. Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air. Anesthesiology. 2015 Feb;122(2):276-85. doi: 10.1097/ALN.0000000000000551.

  PMID: 25603202 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sylvia Wilson, MD
• Organization: Medical University of South Carolina

wilsosh@musc.edu

843-792-2322

Study Officials

• Sylvia H Wilson, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Wanda Jones

  Medical University of South Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 26, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 24, 2019
• Results First Posted: January 24, 2019

Record last verified: 2019-01

Locations

US (1)