HypothermiaNCT05469958
Hypothermia Prevention Measures in Osteosynthesis.
A study testing Hypothermia prevention bundle and Conventional care in people with Hypothermia and Hypothermia, Accidental, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypothermia, Hypothermia, Accidental, Hypothermia; Anesthesia
- What is being tested?
- Hypothermia prevention bundle and Conventional care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 16 Aug 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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".
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.
Read the 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.
- Being tested
- Hypothermia prevention bundle, Conventional care
- Keywords
- hypothermia, body temperature, inadvertent hypothermia, unplanned hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermia prevention bundleOther
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 careOther
the patient will be attended with textile blankets on patient demand
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | a bundle of hypothermia prevention measures will be applied Receives: Other: Hypothermia prevention bundle |
| Control group | Active comparator | Conventional care with textile blankets under patient demand. Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.])
Measured: perioperative period (since OR arrival until PACU Discharge)
Secondary outcomes (3)
prevalence of inadvertent perioperative hypothermia DESCRIPTION:
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.])
Measured: perioperative period (since OR arrival until Post Anaesthesia Unit Discharge)
incidence of postoperative or postanesthetic tremors in the surgical patient.
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;
Measured: 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
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.
Measured: postoperative period (since Postanaesthesia care unit (PACU) arrival until PACU discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start16 Aug 2022
- Primary completion20 Aug 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESther ESpunes Mestres, Universitat Internacional de Catalunya
- Investigators
- Alberto Gallart Fernández-Puebla, PhD, Study director, Universitat Internacional de CatalunyaJordi Castillo Gracía, PhD, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469958
- Sponsor's protocol ID
- 2021/115-ENF-ASEPEYO nº21/2021
- Other IDs
- INF-2021-14
- Status last verified
- May 2024
- First submitted
- 14 Jul 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balki I, Khan JS, Staibano P, Duceppe E, Bessissow A, Sloan EN, Morley EE, Thompson AN, Devereaux B, Rojas C, Rojas C, Siddiqui N, Sessler DI, Devereaux PJ. Effect of Perioperative Active Body Surface Warming Systems on Analgesic and Clinical Outcomes: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2020 Nov;131(5):1430-1443. doi: 10.1213/ANE.0000000000005145.
PubMed 33079867Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16.
PubMed 18927450Kollmann Camaiora A, Brogly N, Alsina E, de Celis I, Huercio I, Gilsanz F. Validation of the Zero-Heat-Flux thermometer (SpotOn(R)) in major gynecological surgery to monitor intraoperative core temperature: a comparative study with esophageal core temperature. Minerva Anestesiol. 2019 Apr;85(4):351-357. doi: 10.23736/S0375-9393.18.12188-2. Epub 2018 Jun 26.
PubMed 29945430Gomez-Romero FJ, Fernández-Prada M, Fernández-Suárez FE, Gutiérrez-Gonzalez C, Estrada-Martínez M, Cachero-Martínez D, Suárez-Fernández S, García-González N, Picatto-Hernández MD, Martínez- Ortega C, Navarro-Garcia JF. Intra-operative temperatura monitoring with two non-invasive devices (3M SpotOn and Dräger Tcore) in comparison with the swan-Ganz catheter. Cir Cardiov 2019; 26(4): 191-196.
Eshraghi Y, Nasr V, Parra-Sanchez I, Van Duren A, Botham M, Santoscoy T, Sessler DI. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014 Sep;119(3):543-549. doi: 10.1213/ANE.0000000000000319.
PubMed 25045862Su SF, Nieh HC. Efficacy of forced-air warming for preventing perioperative hypothermia and related complications in patients undergoing laparoscopic surgery: A randomized controlled trial. Int J Nurs Pract. 2018 Oct;24(5):e12660. doi: 10.1111/ijn.12660. Epub 2018 Apr 23.
PubMed 29682865Ruetzler K, Kurz A. Consequences of perioperative hypothermia. Handb Clin Neurol. 2018;157:687-697. doi: 10.1016/B978-0-444-64074-1.00041-0.
PubMed 30459033Granum MN, Kaasby K, Skou ST, Gronkjaer M. Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery: A Nonrandomized Controlled Study of Two Different Methods of Preoperative and Intraoperative Warming. J Perianesth Nurs. 2019 Oct;34(5):999-1005. doi: 10.1016/j.jopan.2019.03.004. Epub 2019 Jun 15.
PubMed 31213348Aydin H, Simsek T, Demiraran Y. Effects of Inadvertent Perioperative Hypothermia on Metabolic and Inflammatory Mediators. Turk J Anaesthesiol Reanim. 2019 Dec;47(6):448-455. doi: 10.5152/TJAR.2019.94715. Epub 2019 Aug 15.
PubMed 31828241Kang S, Park S. Effect of the ASPAN Guideline on Perioperative Hypothermia Among Patients With Upper Extremity Surgery Under General Anesthesia: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Jun;35(3):298-306. doi: 10.1016/j.jopan.2019.11.004. Epub 2020 Jan 28.
PubMed 32005604Camus Y, Delva E, Lienhart A. Hypothermie peropératoire non provoquee chez l'adulte. EMC (Elsevier Masson SAS, Paris), Anesthésie-Réanimation, 36-413-A-10,2007.
Boddu C, Cushner J, Scuderi GR. Inadvertent Perioperative Hypothermia During Orthopedic Surgery. Am J Orthop (Belle Mead NJ). 2018 Jul;47(7). doi: 10.12788/ajo.2018.0056.
PubMed 30075036Duff J, Walker K, Edward KL, Ralph N, Giandinoto JA, Alexander K, Gow J, Stephenson J. Effect of a thermal care bundle on the prevention, detection and treatment of perioperative inadvertent hypothermia. J Clin Nurs. 2018 Mar;27(5-6):1239-1249. doi: 10.1111/jocn.14171. Epub 2018 Feb 1.
PubMed 29149456Nordgren M, Hernborg O, Hamberg A, Sandstrom E, Larsson G, Soderstrom L. The Effectiveness of Four Intervention Methods for Preventing Inadvertent Perioperative Hypothermia During Total Knee or Total Hip Arthroplasty. AORN J. 2020 Mar;111(3):303-312. doi: 10.1002/aorn.12961.
PubMed 32128778Akers JL, Dupnick AC, Hillman EL, Bauer AG, Kinker LM, Hagedorn Wonder A. Inadvertent Perioperative Hypothermia Risks and Postoperative Complications: A Retrospective Study. AORN J. 2019 Jun;109(6):741-747. doi: 10.1002/aorn.12696.
PubMed 31135987
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT05469958
- Acronym / sponsor ID
- 2021/115-ENF-ASEPEYO nº21/2021
- Keywords
- hypothermia, body temperature, inadvertent hypothermia, unplanned hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Hypothermia prevention bundlea bundle of hypothermia prevention measures will be applied |
| Control group | Active comparator | Other: Conventional careConventional care with textile blankets under patient demand. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermia prevention bundlepre-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 | Other | Intervention group |
| Conventional carethe patient will be attended with textile blankets on patient demand | Other | Control group |
Primary outcome
incidence of perioperative hypothermia
Time frame: 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.])
3 secondary outcomes
prevalence of inadvertent perioperative hypothermia DESCRIPTION:
Time frame: perioperative period (since OR arrival until Post Anaesthesia Unit Discharge)
incidence of postoperative or postanesthetic tremors in the surgical patient.
Time frame: 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
Time frame: postoperative period (since Postanaesthesia care unit (PACU) arrival until PACU discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 33079867Balki I, Khan JS, Staibano P, Duceppe E, Bessissow A, Sloan EN, Morley EE, Thompson AN, Devereaux B, Rojas C, Rojas C, Siddiqui N, Sessler DI, Devereaux PJ. Effect of Perioperative Active Body Surface Warming Systems on Analgesic and Clinical Outcomes: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesth Analg. 2020 Nov;131(5):1430-1443. doi: 10.1213/ANE.0000000000005145.
- Background: PubMed 18927450Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16.
- Background: PubMed 29945430Kollmann Camaiora A, Brogly N, Alsina E, de Celis I, Huercio I, Gilsanz F. Validation of the Zero-Heat-Flux thermometer (SpotOn(R)) in major gynecological surgery to monitor intraoperative core temperature: a comparative study with esophageal core temperature. Minerva Anestesiol. 2019 Apr;85(4):351-357. doi: 10.23736/S0375-9393.18.12188-2. Epub 2018 Jun 26.
- BackgroundGomez-Romero FJ, Fernández-Prada M, Fernández-Suárez FE, Gutiérrez-Gonzalez C, Estrada-Martínez M, Cachero-Martínez D, Suárez-Fernández S, García-González N, Picatto-Hernández MD, Martínez- Ortega C, Navarro-Garcia JF. Intra-operative temperatura monitoring with two non-invasive devices (3M SpotOn and Dräger Tcore) in comparison with the swan-Ganz catheter. Cir Cardiov 2019; 26(4): 191-196.
- Background: PubMed 25045862Eshraghi Y, Nasr V, Parra-Sanchez I, Van Duren A, Botham M, Santoscoy T, Sessler DI. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014 Sep;119(3):543-549. doi: 10.1213/ANE.0000000000000319.
- Background: PubMed 29682865Su SF, Nieh HC. Efficacy of forced-air warming for preventing perioperative hypothermia and related complications in patients undergoing laparoscopic surgery: A randomized controlled trial. Int J Nurs Pract. 2018 Oct;24(5):e12660. doi: 10.1111/ijn.12660. Epub 2018 Apr 23.
- Background: PubMed 30459033Ruetzler K, Kurz A. Consequences of perioperative hypothermia. Handb Clin Neurol. 2018;157:687-697. doi: 10.1016/B978-0-444-64074-1.00041-0.
- Background: PubMed 31213348Granum MN, Kaasby K, Skou ST, Gronkjaer M. Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery: A Nonrandomized Controlled Study of Two Different Methods of Preoperative and Intraoperative Warming. J Perianesth Nurs. 2019 Oct;34(5):999-1005. doi: 10.1016/j.jopan.2019.03.004. Epub 2019 Jun 15.
- Background: PubMed 31828241Aydin H, Simsek T, Demiraran Y. Effects of Inadvertent Perioperative Hypothermia on Metabolic and Inflammatory Mediators. Turk J Anaesthesiol Reanim. 2019 Dec;47(6):448-455. doi: 10.5152/TJAR.2019.94715. Epub 2019 Aug 15.
- Background: PubMed 32005604Kang S, Park S. Effect of the ASPAN Guideline on Perioperative Hypothermia Among Patients With Upper Extremity Surgery Under General Anesthesia: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Jun;35(3):298-306. doi: 10.1016/j.jopan.2019.11.004. Epub 2020 Jan 28.
- BackgroundCamus Y, Delva E, Lienhart A. Hypothermie peropératoire non provoquee chez l'adulte. EMC (Elsevier Masson SAS, Paris), Anesthésie-Réanimation, 36-413-A-10,2007.
- Background: PubMed 30075036Boddu C, Cushner J, Scuderi GR. Inadvertent Perioperative Hypothermia During Orthopedic Surgery. Am J Orthop (Belle Mead NJ). 2018 Jul;47(7). doi: 10.12788/ajo.2018.0056.
- Spanish Society of Preventive Medicine, Public Health and Hygiene. \[Internet\].Madrid. Zero Infection Project.Link provided by the sponsor.
- European Centre for Disease Prevention and Control. \[Internet\]. Stockholm. Annual reports ECDC. Healthcare-associated infections: surgical site infections.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Gallart Fernández-Puebla, PhD study director
Universitat Internacional de Catalunya
Jordi Castillo Gracía, PhD study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermia prevention bundle and Conventional care in people with Hypothermia and Hypothermia, Accidental, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of perioperative hypothermia (time frame: perioperative period (since OR arrival until PACU Discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05469958, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.