Observational Examination of Thermoregulation in Total Joint Arthroplasty

NCT ID: NCT02225743

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-06-30

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.

Detailed Description

Peri-operative hypothermia can have deleterious effects. While there is no standard consistent definition within the literature mild hypothermia is commonly defined as a core temperature between 34 and 36 °C. Mild hypothermia has been shown to increase the occurrence of surgical site infections, cardiac morbidity, coagulopathy leading to increased blood loss and transfusion requirements, impaired drug metabolism, and prolonged emergence from anesthesia. In addition, there is evidence that maintaining intra-operative normothermia can shorten hospital length of stay. Despite the fact that intra-operative temperature monitoring and warming are considered standard of care, peri-operative hypothermia in total joint arthroplasty patients remains an issue for several reasons. A large proportion of patient undergoing joint replacement are elderly, making them susceptible to peri-operative hypothermia. In addition, regional anesthesia causes vasodilation and promotes heat flow from the core to the periphery and impairs central and autonomic thermoregulation such that patients receiving neuraxial anesthesia can be particularly susceptible to perioperative hypothermia. Finally, core temperature monitoring is typically not used during regional anesthesia and hypothermia may go undetected for long periods of time.

The primary goal of this study was to examine the incidence of hypothermia during lower extremity arthroplasty. A secondary aim was to identify patient and operative factors associated with hypothermia in order to improve future preventative strategies. Our hypothesis was that peri-operative hypothermia occurs in the majority of patients undergoing lower extremity arthroplasty. In addition, we hypothesized that certain patient and anesthetic factors (such as low body mass index and receiving general anesthesia) would increase the incidence of hypothermia.

Conditions

Hypothermia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Joint Arthroplasty

Participants undergoing joint replacement

Observation Of Temperature

Intervention Type: OTHER

Participants temperature will be recorded perioperatively.

Interventions

Observation Of Temperature

Participants temperature will be recorded perioperatively.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients unable to give informed consent will be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia H Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Wanda Jones

Role: STUDY_DIRECTOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18494388 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8606715 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22388109 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25603202 (View on PubMed)

Other Identifiers

Pro00035290

Identifier Type: OTHER

Identifier Source: secondary_id

Thermoregulation Total Joint

Identifier Type: -

Identifier Source: org_study_id