Hypothermia; Anesthesia, Hypothermia Following Anesthesia
Conditions
Brief summary
This prospective, randomized, single-center study compares intraoperative heat loss at the core temperature level in patients scheduled for direct anterior total hip arthroplasty under general anesthesia and who will or will not, according to randomization, receive one hour of pre-warming with a pulsed air thermal blanket prior to anesthesia induction.
Detailed description
In patients undergoing surgery, intraoperative hypothermia can occur because of anesthesia-induced inhibition of thermoregulation and heat loss associated with the patient's exposure to an environment maintained at a temperature below normal skin temperature. Randomized trials show that even mild hypothermia results in serious complications, including surgical wound infection, coagulopathy and increased blood transfusions, and delayed postoperative recovery. All products used during general anesthesia profoundly alter thermoregulatory control, reducing the activation thresholds of the main defenses against cold, which are the closure of the arteriovenous shunt and the generation of shivering. Impaired thermoregulation, combined with a cold operating room environment and direct-anterior hip surgical approach and exposure, causes hypothermia in almost all unheated patients. The body core temperature is finely tuned to maintain an average of 37°C by balancing heat gain and loss. The nasopharynx is an excellent alternative to patient core temperature monitoring when esophageal monitoring is excluded for surgical reasons or blocked by an airway protected by an airway device.
Interventions
PROCEDUREPreoperative warming
Patients enrolled in surgery who will not receive 30 minutes of pulsed air thermal blanket warming prior to induction of anesthesia (3M™ Bair Hugger™ Adult Integral Blanket, Model 300 Dimensions: 213 cm x 91 cm)
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Unblinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA 1-2-3 * Scheduled for direct anterior-approached total hip replacement surgery under general anesthesia
Exclusion criteria
* pregnant women * patients with: 1. peripheral neuropathy or other severe neurological pathology 2. immunosuppression 3. chronic renal insufficiency or severe hepatic insufficiency 4. major congenital or acquired hemostasis disorders 5. craniofacial dysmorphism or anatomical alterations of the upper airways 6. known thermoregulatory disorders * patients with a preoperative body temperature \> 37.5°C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core body temperature | Intraoperative | Variation of core body temperature during surgery, i.e. the difference between the temperature at the time of induction of general anaesthesia and the minimum temperature recorded during the procedure, as well as its evolution over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shivering | First 6 hours after surgery | The incidence of shivering in the first 6 hours post-surgery |
| Patient comfort | First 6 hours after surgery | Comfort in the recovery room by visual analogical scale (VAS 0-100) |
| Surgical site infection | 30 days after surgery | Incidence of surgical site infection at 30 days postoperative |
| Intraoperative blood loss | Intraoperative | Total intraoperative blood loss |
| QoR-15 | Day-1 and Day-3 after surgery | Postoperative patient satisfaction and functional outcome (QoR-15 at D1 and D3) |
| LoS | 30 days after surgery | Length of stay in hospital |
| Postoperative complications | 3 days after surgery | The occurrence of side effects related to hypothermia (cardiovascular, infectious and hemorrhagic complications) |
Countries
Belgium
Outcome results
None listed