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Study on the Incidence of Perioperative Hypothermia at the Surgical Area of Parc Tauli Hospital Universitari, Sabadell (PREVINQ-WARM)

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ClinicalTrials.gov Identifier: NCT03961620
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Xavier Guirao, Corporacion Parc Tauli

Brief Summary:
The study TAULÍ-PREVINQ-WARM will assess the rate of perioperative hypothermia in patients submitted to major surgical procedures at the operating room main area (and at the ambulatory surgery building for ophthalmologic major procedures) of the Parc Taulí, Hospital Universitari, Sabadell, Barcelona.

Condition or disease Intervention/treatment
Hypothermia Device: The SpotOn system that encompasses the registration unit (3M SpotOn Control Unit), disposable sensor (3M SpotOn Control Sensor) along with the cords and electric power unit.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on the Incidence of Perioperative Hypothermia and the Effect of Standard Normothermia Measures at the Surgical Area of Parc Tauli Hospital Universitari, Sabadell: Tauli-Previnq-Warm
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: The SpotOn system that encompasses the registration unit (3M SpotOn Control Unit), disposable sensor (3M SpotOn Control Sensor) along with the cords and electric power unit.
    Patients submitted to major surgical procedure will be assessed for core body temperature by employing SpotOn sensor device, before, during and after surgical procedure.


Primary Outcome Measures :
  1. Rate of perioperative hypothermia (<36ºC) [ Time Frame: 12 hours ]
    Body temperature measured by SpotOn system sensor in different surgical procedures and at any specific surgical area.


Secondary Outcome Measures :
  1. Type and duration of applied physical measures to prevent periopertive hypothermia [ Time Frame: 12 hours ]
    The investigators will corroborate whether or not textile blankets, forced air warming blankets or additional measures are applied, anf if so, the time and durations of such measures.

  2. Temperature at the operating room [ Time Frame: 1-6 hours ]
    Temperature and degree of humidity at the OR

  3. Thermal confort [ Time Frame: 1-6 hours ]
    Thermal comfort of patients and OR staff members

  4. Adverse events [ Time Frame: Up to 30 days (1 year for prosthetic surgery) ]
    Rate of postoperative adverse events



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Ages Eligible for Study:   8 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients submitted to elective major surgical procedures from different surgical specialties
Criteria

Inclusion Criteria:

  • ASA score I to IV
  • Patients submitted to major surgical procedures at the main OR facilities (or at the ambulatory surgery building for ophthalmologic procedures) under general or neuraxial anesthesia from surgical specialties
  • Patients (parents or legal guardians regarding pediatric patients) that have signed informed consent form.

Exclusion Criteria:

  • Patients submitted to craniofacial neurosurgical procedures
  • Patients submitted to any surgical procedure requiring draping or sterile isolation of the frontal part of head, precluding intraoperative assessment of SpotOn sensor.
  • Patients (parents or legal guardians regarding pediatric patients) that have not signed informed consent form.
  • Patients that by the time of the hospital admission present a relevant inflammatory or infectious process at the skin of frontal part of the head
  • Patients diagnosed with psychiatric disease relevant enough to avoid adequate staff-patients communication for this specific study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961620


Contacts
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Contact: Xavier Guirao, MD +34 937 23 10 10 ext 29501 fjguirao@tauli.cat

Sponsors and Collaborators
Corporacion Parc Tauli
3M
Investigators
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Principal Investigator: Xavier Guirao, MD Parc Tauli Hospital Universitari, Sabadell

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Responsible Party: Xavier Guirao, Coordinator of Endocrine, Head and Neck Surgery Unit, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03961620     History of Changes
Other Study ID Numbers: 2018/630
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xavier Guirao, Corporacion Parc Tauli:
perioperative hypothermia
core temperature
perioperative normothermia

Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms