Study Results
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Basic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2022-08-16
2024-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group
a bundle of hypothermia prevention measures will be applied
Hypothermia prevention bundle
pre-warming of the patient for 10 minutes with forced air blankets before the surgery starts, which will be maintained during surgery and during the immediate postoperative period, the intravenous perfusions will be warmed up to 38 Celsius degree (ºC) and the environmental temperature will be controlled at 21 Celsius degree (ºC) during surgery
Control group
Conventional care with textile blankets under patient demand.
Conventional care
the patient will be attended with textile blankets on patient demand
Interventions
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Hypothermia prevention bundle
pre-warming of the patient for 10 minutes with forced air blankets before the surgery starts, which will be maintained during surgery and during the immediate postoperative period, the intravenous perfusions will be warmed up to 38 Celsius degree (ºC) and the environmental temperature will be controlled at 21 Celsius degree (ºC) during surgery
Conventional care
the patient will be attended with textile blankets on patient demand
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Universitat Internacional de Catalunya
OTHER
Responsible Party
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ESther ESpunes Mestres
Principal Investigator
Principal Investigators
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Alberto Gallart Fernández-Puebla, PhD
Role: STUDY_DIRECTOR
Universitat Internacional de Catalunya
Jordi Castillo Gracía, PhD
Role: STUDY_DIRECTOR
Universitat Internacional de Catalunya
Locations
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Asepeyo Hospital
Sant Cugat del Vallès, Barcelona-CATALUNYA, Spain
Countries
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References
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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Spanish Society of Preventive Medicine, Public Health and Hygiene. \[Internet\].Madrid. Zero Infection Project.
European Centre for Disease Prevention and Control. \[Internet\]. Stockholm. Annual reports ECDC. Healthcare-associated infections: surgical site infections.
NHSN: National Healthcare Safety Network \[Internet\]USA: United States department of health \&human services; Patient Safety Component manual: Surgical Site Infection (SSI)
International organization for standardization (2020). Ergonomics of the thermal environment. (Standard No. 10551:2019.
Other Identifiers
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INF-2021-14
Identifier Type: OTHER
Identifier Source: secondary_id
2021/115-ENF-ASEPEYO nº21/2021
Identifier Type: -
Identifier Source: org_study_id
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