Perioperative Hypothermia
Conditions
Brief summary
The purpose of this study is to determine if placement of a forced-air warming device prior to institution of regional anesthesia improves perioperative temperature control in patients undergoing total hip arthroplasty.
Interventions
DEVICEBair-Paws Warming Device
Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
DEVICEBair-Hugger Warming Device
Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing total hip arthroplasty under neuraxial anesthesia, * age 55-85, * BMI 18-40
Exclusion criteria
* allergy to local anesthetics, * patients electing to have general anesthesia for their total hip arthroplasty, * pregnancy, * prisoners, * patients unable to give informed consent, * English as a second language, * active infectious or febrile illness (measured temperature \> 37.5 degrees Celsius).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System.. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | — |
| Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | — |
| Incidence of Postoperative Shivering in Recovery Room. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | — |
| Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | — |
| Incidence of Perioperative Cardiac Events. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | Incidence of perioperative arrhythmias or myocardial ischemia. |
| Temporal Artery Verus SpotOn (3M) Temperature Readings. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision. |
| Intraoperative Blood Loss. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | Intraoperative blood loss in mL's. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre-Warming Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming. | 47 |
| Control Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution). | 51 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Pre-Warming | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 28 Participants | 54 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 23 Participants | 44 Participants |
| Age, Continuous | 66.1 years STANDARD_DEVIATION 6.37 | 66.5 years STANDARD_DEVIATION 7.41 | 66.3 years STANDARD_DEVIATION 6.9 |
| Baseline Temperature | 36.6 Degrees Celisius STANDARD_DEVIATION 0.4 | 36.7 Degrees Celisius STANDARD_DEVIATION 0.37 | 36.6 Degrees Celisius STANDARD_DEVIATION 0.39 |
| Region of Enrollment United States | 47 participants | 51 participants | 98 participants |
| Sex: Female, Male Female | 27 Participants | 24 Participants | 51 Participants |
| Sex: Female, Male Male | 20 Participants | 27 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 51 |
| serious Total, serious adverse events | 0 / 47 | 0 / 51 |
Outcome results
Primary
Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Warming | Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System.. | 35.7 Degrees Celsius | Standard Deviation 0.47 |
| Control | Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System.. | 35.4 Degrees Celsius | Standard Deviation 0.49 |
Secondary
Incidence of Perioperative Cardiac Events.
Incidence of perioperative arrhythmias or myocardial ischemia.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Warming | Incidence of Perioperative Cardiac Events. | 1 Patients |
| Control | Incidence of Perioperative Cardiac Events. | 0 Patients |
Secondary
Incidence of Postoperative Shivering in Recovery Room.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-Warming | Incidence of Postoperative Shivering in Recovery Room. | 1 Number of patients reporting shivering |
| Control | Incidence of Postoperative Shivering in Recovery Room. | 14 Number of patients reporting shivering |
Secondary
Intraoperative Blood Loss.
Intraoperative blood loss in mL's.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Warming | Intraoperative Blood Loss. | 263 mL | Standard Deviation 109 |
| Control | Intraoperative Blood Loss. | 307 mL | Standard Deviation 116 |
Secondary
Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Warming | Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System. | 35.7 Degrees Celsius | Standard Deviation 0.4 |
| Control | Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System. | 35.4 Degrees Celsius | Standard Deviation 0.4 |
Secondary
Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Warming | Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System. | 35.4 Degrees Celsius | Standard Deviation 0.8 |
| Control | Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System. | 35.1 Degrees Celsius | Standard Deviation 0.6 |
Secondary
Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Warming | Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System. | 36.7 Degrees Celsius | Standard Deviation 0.4 |
| Control | Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System. | 36.6 Degrees Celsius | Standard Deviation 0.4 |
Secondary
Temporal Artery Verus SpotOn (3M) Temperature Readings.
Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.
Time frame: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Warming | Temporal Artery Verus SpotOn (3M) Temperature Readings. | 36.5 Degrees Celsius | Standard Deviation 0.5 |
| Control | Temporal Artery Verus SpotOn (3M) Temperature Readings. | 36.5 Degrees Celsius | Standard Deviation 0.5 |