Clinical trial NCT05469958: Hypothermia Prevention Measures in Osteosynthesis.
Official title: Efficacy of Perioperative Hypothermia Prevention Measures in Osteosynthesis. Clinical Trial With Control Group and Validation Into Spanish of the "BEDSIDE SHIVERING ASSESSMENT SCALE".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Hypothermia, Accidental
Hypothermia; Anesthesia
Keywords: hypothermia
body temperature
inadvertent hypothermia
unplanned hypothermia
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized control study with a control group and 90 days follow-up for assessing the decrease in the incidence of inadvertent perioperative hypothermia in the osteosynthesis surgical patients after the application of a bundle in prevention measures during the perioperative period, assessing thermal comfort, tremors (validation into spanish a tremors assessment scale), surgical site infections and readmissions.

Detailed description: Introduction: Perioperative hypothermia, defined as a core body temperature lower than 36 ºC (Celsius degree), is a major problem in the surgical setting. Between 20 and 70% of patients may develop it unintentionally, affecting, to varying degrees, patient safety. Since the beginning of the 90's, serious complications associated with its appearance have been described: infection, alteration of thermal comfort, shivering and increased readmissions.

Objective: to identify whether the application of a bundle of prevention measures against the occurrence of Inadvertent Perioperative Hypothermia in the osteosynthesis surgical patient decreases the incidence of perioperative hypothermia. Secondary objectives to identify the prevalence of inadvertent perioperative hypothermia in the osteosynthesis surgical patient, to determine if the application of a bundle of preventive measures against the occurrence of inadvertent hypothermia decreases the incidence of postoperative or postanesthetic tremors in the surgical patient, to determine if the application of a bundle of preventive measures against the occurrence of inadvertent hypothermia increases the thermal comfort of surgical patients in the immediate postoperative period, to identify the impact of the application of a bundle of prevention measures against the occurrence of inadvertent perioperative hypothermia in the osteosynthesis surgical patients in relation to surgical site infection up to 90 days postoperative follow up and hospital readmissions associated with the occurrence of infection up to 90 days from surgery, to identify possible variables related to the incidence of surgical site infection at 90 days in the hypothermic patient with respect to the normothermic patient and to validate the Spanish translation of the "BEDSIDE SHIVERING ASSESSMENT SCALE" for tremors in the post anesthesia care unit (PACU).

Methodology:First phase: validation and adaptation to Spanish of the "BEDSIDE SHIVERING ASSESSMENT SCALE" (measurement of tremor in patients) with a prospective study with 40 patients.

Second phase: a controlled Randomized Clinical Trial (RCT) will be carried out, in which the intervention group (IG) will implement the bundle of prevention measures against the appearance of perioperative hypothermia and the control group (CG), the usual treatment with textile blankets will be carried out at the patient's request.

A stratified randomization will be carried out to guarantee an equal distribution by groups in the variables type of operating room, type of anesthesia, anesthetic risk (ASA Physical Status 3, maintaining an equal or similar cluster in both the IG and the CG.

124 osteosynthesis trauma surgery patients will be randomized, 62 in each group.

To the intervention group, a bundle of hypothermia prevention measures will be applied before the start of anesthesia, based on: pre-warming of the patient for 10 minutes with a convective heating system (forced air blankets) which will be maintained during surgery and immediate postoperative period, intravenous perfusions will be warmed to 38 Celsius degree(ºC) and the environmental temperature will be controlled at 21 Celsius degree(ºC) . To the control group, will perform the usual treatment with textile blankets on patient demand as usual.

This study will be carried out at the Economic Health Assistance for Employees and Laborers hospital (ASEPEYO) in Barcelona (Spain) which is an accidents at work hospital. The target population is all patients undergoing osteosynthesis trauma surgery of the upper limb, lower limb, and spine.

Expected results: an improvement in patient safety is expected with a decrease in the incidence of perioperative hypothermia, shivering, with an improvement in postoperative thermal comfort.

Eligibility criteria: Inclusion Criteria:

* Undergoing general, spinal locoregional and peripheral locoregional anesthesia, with or without sedation, with nature of elective and urgent surgery in the specialty of trauma surgery with osteosynthesis technique in lower extremities, upper extremities (including clavicle) and spine.

Exclusion Criteria:

* patient in surgical protocol for positive Coronavirus 19 desease, febrile process, thyroid pathology (hypothyroidism/hyperthyroidism), treatment with nitrates, hemodynamically unstable that may require resuscitation with massive intravenous fluids; osteosynthesis in fingers, metacarpals, metatarsals and distal radius fractures, Grade III open fractures, as well as all patients with Quetelet Body Mass Index with value higher than 40 Kg/m2

Primary outcomes:
measure: incidence of perioperative hypothermia
timeFrame: perioperative period (since OR arrival until PACU Discharge)
Secondary outcomes:
measure: prevalence of inadvertent perioperative hypothermia DESCRIPTION:
timeFrame: perioperative period (since OR arrival until Post Anaesthesia Unit Discharge)
measure: incidence of postoperative or postanesthetic tremors in the surgical patient.
timeFrame: postoperative period (since Postanaesthesia care unit arrival until the first documented vital sign registration)
measure: incidence of postoperative or postanesthetic tremors in the surgical patient. assessment of thermal comfort in postanesthesia care unit
timeFrame: postoperative period (since Postanaesthesia care unit (PACU) arrival until PACU discharge)
Other outcomes:
measure: incidence of infection up to 90 days postoperatively.
timeFrame: Data will be collected for the PI three times in the postoperative period; the day 30 after surgery, the day 60 after surgery, and de day 90 after surgery. The day of the surgery will be considered the day 1.
measure: incidence of readmission related to infection
timeFrame: Data will be collected for the PI three times in the postoperative period; the day 30 after surgery, the day 60 after surgery, and de day 90 after surgery. The day of the surgery will be considered the day 1.
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Asepeyo Hospital
state: Barcelona-CATALUNYA
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Alberto Gallart Fernández-Puebla, PhD
role: STUDY_DIRECTOR
affiliation: Universitat Internacional de Catalunya
name: Jordi Castillo Gracía, PhD
role: STUDY_DIRECTOR
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