Study on the Incidence of Perioperative Hypothermia at the Surgical Area of Parc Tauli Hospital Universitari, Sabadell
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Observational

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.
    

Detailed description: 
      Treatment plan The month before the start of the study, investigators will double check with
      the administrative personnel the potential candidates to be included in to the study.
      Furthermore, investigators will meet with the responsible of each surgical specialty to
      delineate the adequate staff workload and collaborators needs. To assure the best study
      performance and to avoid selection patient bias, patients will be consecutively included in
      blocs of each designated surgical specialty.

      At the patient admission area and surgical preparation, associated investigators will inform
      to candidates and relatives about the project giving the informed form to be signed.

      Patient inclusion will include a pilot phase (four to five patients) to teach collaborators
      regarding the correct placement of cutaneous sensor, data lecture and registration to the
      database. Along with the maintenance department of the hospital, we also assess the correct
      installation and function of temperature and humidity sensors at the OR (Mini-datalogger
      174H, Instrumentos Testo, S.A. Cabrils, Barcelona). OR temperature and the degree of humidity
      will be measured at the specific time points stated at the paragraph of the measurements.

      Body temperature (BT) measurements will be performed at the UPQ, anesthesia preparation room,
      OR and URPA in those specifically stated time points (Annex 2 and Figure 1).

      Because the investigators want to perform a pragmatic study, patients will receive
      conventional normothermia preventive measures following the approved local guidelines from
      the Anesthesiology Department.

      Measurement and data entry Body temperature (BT) Patient's BT will be assessed with 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.

      Non-invasive digital BT system monitorization SpotOn, includes a sensor that by adhering to
      the lateral side of supra-ocular region, allows for continued registration of BT for the
      overall surgical process.

      Number of times and sites of BT registration Staff devoted to assess BT measurements. Staff
      from 3M, will advise nurses, anesthesiologists and investigators regarding SpotOn
      specifications and management at the beginning of the study

      Because OR temperature and degree of humidity may have some influence on patient's BT and
      thermic comfort both patients and OR staff, OR temperature and humidity will be registered at
      the beginning and at the end of surgical procedure. Also, the protocol will take in to the
      account weather conditions registered at the MeteoCat and will be included at the data base
      regularly. Also, staff from Maintenance of Hospital Facilities and Equipment, will set up and
      store data from the OR temperature and humidity sensors (Mini-datalogger 174H, Instrumentos
      Testo, S.A. Cabrils, Barcelona).

      Data about measures addressed to sustain perioperative normothermia will also be recorded
      (see Annex 4)

      At the end of surgical procedure the investigators will ask patients and OR staff for running
      a visual analogic scale punctuation (1 to 10) regarding the perceived thermal comfort (see
      Annex 5)

      Length of the study and period of patients recruitment. Because the specific nature of this
      prospective observational and pragmatic study, the rate of patients recruitment will be
      assessed frequently to accommodate both optimal patient accrual and fair and adequate entry
      data. The approximate time for total patients inclusion will be of one year.

      Sample size The main objective of the study TAULI-PREVINQ-WARM is to assess the rate of
      perioperative hypothermia (<36ªC) at some point during the surgical process in patients
      operated on for a major surgical procedure at the Parc Tauli, Hospital Universitari,
      Sabadell. Then, sample size has been calculated taking in to the account that roughly 50% of
      patients will have some kind of hypothermia with 10% of variability of 95% CI. Assuming a10%
      of repository additional patients, 110 patients will be included overall.

      Assessment of data results and statistical analysis. The TAULI-PREVINQ-WARM is a pragmatic
      study that wants to assess body temperature in surgical patients under regular clinical
      conditions. We will perform a descriptive analysis of data by depicting mainly frequency
      distribution analysis of the qualitative main variable, HypoTer. The proposed sample size
      will allow also for assessing the rate HypoTer at each different surgical areas where
      patients are admitted. Also, repeated measures will be compared among different surgical
      procedures at the OR taking in to consideration the body surface area under regular
      preventive normothermia measures, following the general lineal model. Univariate two-sided
      analysis will be perform for all comparisons and parametric or non-parametric analysis will
      be performed accordingly. Multivariate analysis might eventually be performed depending of
      the rate of events.
    

Intervention name(s): 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.
Intervention type(s): Device
Intervention description(s): Patients submitted to major surgical procedure will be assessed for core body temperature by employing SpotOn sensor device, before, during and after surgical procedure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients submitted to elective major surgical procedures from different surgical
        specialties
      
Keywords: perioperative hypothermia; core temperature; perioperative normothermia