Hypothermia Prevention Measures in Osteosynthesis.

NCT05469958 | Completed

• 2 other identifiers: 2021/115-ENF-ASEPEYO nº21/2021INF-2021-14
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Hypothermia, Accidental; Hypothermia; Anesthesia

Keywords

hypothermia; body temperature; inadvertent hypothermia; unplanned hypothermia

Outcome Measures

Primary Outcomes (1)

• incidence of perioperative hypothermia

  Core temperature assessed with 3M (registered trademark) Spot-on dual sensor thermometer. It will be attached to the frontal region of the patient in awake and anesthetized patient. Validated in the USA by Eshragui et al. in 2014. Compared with pulmonary artery catheter (gold standard), difference of 0,5 ºC; validated in Spain by Gómez-Romero et al. in 2019; 289 repeated measures, Spearman correlation coefficient (r) 0.82\[95% Confidence Interval (CI)\] 0.77-0.85 with p\<0.001, with an interrelation coefficient (ICC) of 0.88 (95%CI 0.85-0.90). Bland-Altman repeated measures analysis for Spot-On and Swan Ganz catheter revealed a bias (SD) \[95% CI\] of 0,21°C (0.34) \[-2.27 to 2.71\]. Kollmann-Camaiora et al. validated it in 2019 respect to esophageal temperature probe measurement. Bland Altman Plot, Pearson Correlation (PC) and intraclass correlation coefficient with 400 repeated measures: PC 0.82, Bias of -0.27(95%CI \[-0.61-0.55\], and ICC 0.90 (95%CI \[0.88-0.92.\])

  perioperative period (since OR arrival until PACU Discharge)

Secondary Outcomes (3)

• prevalence of inadvertent perioperative hypothermia DESCRIPTION:

  perioperative period (since OR arrival until Post Anaesthesia Unit Discharge)

• incidence of postoperative or postanesthetic tremors in the surgical patient.

  postoperative period (since Postanaesthesia care unit arrival until the first documented vital sign registration)

• incidence of postoperative or postanesthetic tremors in the surgical patient. assessment of thermal comfort in postanesthesia care unit

  postoperative period (since Postanaesthesia care unit (PACU) arrival until PACU discharge)

Other Outcomes (2)

• incidence of infection up to 90 days postoperatively.

  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.

• incidence of readmission related to infection

  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.

Study Arms (2)

Intervention group

EXPERIMENTAL

a bundle of hypothermia prevention measures will be applied

Other: Hypothermia prevention bundle

Control group

ACTIVE COMPARATOR

Conventional care with textile blankets under patient demand.

Other: Conventional care

Interventions

Hypothermia prevention bundle OTHER

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

Intervention group

Conventional care OTHER

the patient will be attended with textile blankets on patient demand

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Asepeyo Hospital

Sant Cugat del Vallès, Barcelona-CATALUNYA, 08174, Spain

Location

Related Publications (29)

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Related Links

• 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.

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Gallart Fernández-Puebla, PhD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

• Jordi Castillo Gracía, PhD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is impossible to mask patients; they will notice whether are warmed or not. The care providers must know which protocol to carry on, so it's impossible to mask them. The PI will prepare the assignation groups by an randomization software.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 22, 2022
• Study Start: August 16, 2022
• Primary Completion: August 20, 2023
• Study Completion: May 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)