Hypothermia Prevention Measures in Osteosynthesis.

Sponsor

Universitat Internacional de Catalunya (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05469958

Collaborator

(none)

124

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

19.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia Hypothermia, Accidental Hypothermia; Anesthesia	Other: Hypothermia prevention bundle Other: Conventional care	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Prevention

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".

Anticipated Study Start Date :

Aug 16, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group a bundle of hypothermia prevention measures will be applied	Other: 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
Active Comparator: Control group Conventional care with textile blankets under patient demand.	Other: Conventional care the patient will be attended with textile blankets on patient demand

Arm

Intervention/Treatment

Experimental: Intervention group

a bundle of hypothermia prevention measures will be applied

Other: 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

Active Comparator: Control group

Conventional care with textile blankets under patient demand.

Other: Conventional care

the patient will be attended with textile blankets on patient demand

Outcome Measures

Primary Outcome Measures

incidence of perioperative hypothermia [perioperative period (since OR arrival until PACU Discharge)]
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.])

Secondary Outcome Measures

prevalence of inadvertent perioperative hypothermia DESCRIPTION: [perioperative period (since OR arrival until Post Anaesthesia Unit Discharge)]
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.])
incidence of postoperative or postanesthetic tremors in the surgical patient. [postoperative period (since Postanaesthesia care unit arrival until the first documented vital sign registration)]
BEDSIDE SHIVERING ASSESMENT SCALE (BSAS): ordinal scale that evaluates the presence or absence of postoperative or postanesthetic tremors. Created in 2008 by Badjatia et al. it consists of 4 levels, with a minimum value of 0 and a maximum value of 3;
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)]
Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Scale endorsed by the International Organization for Standardization 10551:2019. Scale for measuring indoor thermal comfort. It consists of 7 Likert-type items, where the patient is asked the sensation of cold or heat before discharge from the PACU; the center of the scale is thermal neutrality (0), the left pole registers cold, and the minimum score is -3 and the right pole evaluates heat and the maximum value is +3.

Other Outcome Measures

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.]
Self-developed questionnaire created ad-hoc for postoperative data collection (Q2), telephone management: it will be validated in parallel to the clinical research study. In relation to infection, the questions will be: Have you had any wound-related problems such as fluid leakage, positive culture specimen, or spontaneous wound opening after surgery? Have you required medical follow-up for deliberate opening of the surgical wound? Have you had localized wound pain, swelling, edema or redness, localized heat, fever? Have you visited an emergency department because of malaise, feeling of fever or fever higher than 38 Celsius degree(ºC)? Have you had any imaging test to diagnose infection? The patient will be considered to have infection when an affirmative answer to 3 of the 5 questions is obtained.
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.]
Self-developed questionnaire created ad-hoc for postoperative data collection (Q2), telephone management: it will be validated in parallel to the clinical research study. In relation to Readmission, the questions will be: Have you been readmitted to a hospital for wound-related problems? 7) Have you had surgery to clean the wound in the operating room?

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asepeyo Hospital	Sant Cugat Del Vallès	Barcelona-CATALUNYA	Spain	08174

Sponsors and Collaborators

Universitat Internacional de Catalunya

Investigators

Study Director: Alberto Gallart Fernández-Puebla, PhD, Universitat Internacional de Catalunya
Study Director: Jordi Castillo Gracía, PhD, Universitat Internacional de Catalunya