Observational Examination of Thermoregulation in Total Joint Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Joint Arthroplasty Participants undergoing joint replacement |
Other: Observation Of Temperature
Participants temperature will be recorded perioperatively.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Hypothermia [Starting with temperature measurement prior to leaving preoperative holding for OR and ending after temperature taken on arrival in recovery room]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
Sponsors and Collaborators
- Medical University of South Carolina
Investigators
- Principal Investigator: Sylvia H Wilson, MD, Medical University of South Carolina
- Study Director: Wanda Jones, Medical University of South Carolina
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. Review.
- 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.
- 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.
- Thermoregulation Total Joint
- Pro00035290
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Joint Arthroplasty |
|---|---|
| Arm/Group Description | Participants undergoing joint replacement Observation Of Temperature: Participants temperature will be recorded perioperatively. |
| Period Title: Overall Study | |
| STARTED | 120 |
| COMPLETED | 102 |
| NOT COMPLETED | 18 |
Baseline Characteristics
| Arm/Group Title | Joint Arthroplasty |
|---|---|
| Arm/Group Description | Participants undergoing joint replacement Observation Of Temperature: Participants temperature will be recorded perioperatively. |
| Overall Participants | 102 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
63.5
(11.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
64
62.7%
|
| Male |
38
37.3%
|
| Total Knee Arthroplasty (Count of Participants) | |
| Count of Participants [Participants] |
54
52.9%
|
Outcome Measures
| Title | Incidence of Hypothermia |
|---|---|
| Description | 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. |
| Time Frame | Starting with temperature measurement prior to leaving preoperative holding for OR and ending after temperature taken on arrival in recovery room |
Outcome Measure Data
| Analysis Population Description |
|---|
| Ever hypothermic (temperature <36.0 degrees C) during the perioperative period |
| Arm/Group Title | Hypothermia |
|---|---|
| Arm/Group Description | Hypothermia was defined as a temperature less than 36.0 °C. . |
| Measure Participants | 102 |
| Count of Participants [Participants] |
74
72.5%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Joint Arthroplasty | |
| Arm/Group Description | Participants undergoing joint replacement Observation Of Temperature: Participants temperature will be recorded perioperatively. | |
All Cause Mortality |
||
| Joint Arthroplasty | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Joint Arthroplasty | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/102 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Joint Arthroplasty | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/102 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sylvia Wilson, MD |
|---|---|
| Organization | Medical University of South Carolina |
| Phone | 843-792-2322 |
| wilsosh@musc.edu |
- Thermoregulation Total Joint
- Pro00035290