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Completed

NCT Number: NCT05213377

Preoperative Warming, Hypothermia and Functional Recovery in Total Hip Arthroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Liège

Liège, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1-2-3
  • Scheduled for direct anterior-approached total hip replacement surgery under general anesthesia

Exclusion criteria

  • pregnant women
  • patients with:
  • peripheral neuropathy or other severe neurological pathology
  • immunosuppression
  • chronic renal insufficiency or severe hepatic insufficiency
  • major congenital or acquired hemostasis disorders
  • craniofacial dysmorphism or anatomical alterations of the upper airways
  • known thermoregulatory disorders
  • patients with a preoperative body temperature > 37.5°C.

Treatment and study plan

Preoperative warming

Procedure

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)

Primary outcomes

  1. Core body temperature

    Time frame: 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 outcomes

  1. Intraoperative blood loss

    Time frame: Intraoperative

    Total intraoperative blood loss

  2. Shivering

    Time frame: First 6 hours after surgery

    The incidence of shivering in the first 6 hours post-surgery

  3. Patient comfort

    Time frame: First 6 hours after surgery

    Comfort in the recovery room by visual analogical scale (VAS 0-100)

  4. Patient comfort

    Time frame: First 6 hours after surgery

    Length of stay in the recovery room

  5. Surgical site infection

    Time frame: 30 days after surgery

    Incidence of surgical site infection at 30 days postoperative

  6. Postoperative complications

    Time frame: 3 days after surgery

    The occurrence of side effects related to hypothermia (cardiovascular, infectious and hemorrhagic complications)

  7. QoR-15

    Time frame: Day-1 and Day-3 after surgery

    Postoperative patient satisfaction and functional outcome (QoR-15 at D1 and D3)

  8. LoS

    Time frame: 30 days after surgery

    Length of stay in hospital

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Effect of Preoperative Warming on Intraoperative Hypothermia and Postoperative Functional Recovery Outcomes in Direct Anterior-approached Total Hip Arthroplasty: a Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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