Study on the Incidence of Perioperative Hypothermia at the Surgical Area of Parc Tauli Hospital Universitari, Sabadell

NCT03961620 | Completed

• 1 other identifier: 2018/630
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia

Keywords

perioperative hypothermia; core temperature; perioperative normothermia

Outcome Measures

Primary Outcomes (1)

• Rate of perioperative hypothermia (<36ºC)

  Body temperature measured by SpotOn system sensor in different surgical procedures and at any specific surgical area.

  12 hours

Secondary Outcomes (4)

• Type and duration of applied physical measures to prevent periopertive hypothermia

  12 hours

• Temperature at the operating room

  1-6 hours

• Thermal confort

  1-6 hours

• Adverse events

  Up to 30 days (1 year for prosthetic surgery)

Interventions

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. DEVICE

Patients submitted to major surgical procedure will be assessed for core body temperature by employing SpotOn sensor device, before, during and after surgical procedure.

Eligibility Criteria

• Age: 8 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients submitted to elective major surgical procedures from different surgical specialties

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• 3M: collaborator

Study Sites (1)

Parc Tauli Hospital Universitari

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

• Xavier Guirao, MD

  Parc Tauli Hospital Universitari, Sabadell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Endocrine, Head and Neck Surgery Unit

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: July 9, 2019
• Primary Completion: December 30, 2021
• Study Completion: February 22, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)