Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
1 other identifier
interventional
70
1 country
1
Brief Summary
Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedSeptember 27, 2016
August 1, 2015
1 year
July 28, 2015
September 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in the Body Core Temperature
measure the body core temperature by Spoton device when the patient arrive to operating room
measure every 15 minutes since the patient arrive to operating room until is derivated to recovery room, an average of 3 hours
Secondary Outcomes (2)
incidence of blood transfusion
In the first two weeks after being operated.
surgical wound infection
while the patient stay in the hospital, an average of two weeks
Study Arms (2)
Spot-on group
ACTIVE COMPARATORUse active measures against intraoperative hypothermia
control
NO INTERVENTIONstandard measures against intraoperative hipothermia
Interventions
Eligibility Criteria
You may qualify if:
- All patients that need a colorrectal laparoscopic surgery
You may not qualify if:
- Use of antagonist of Calcium
- Alergy to medications
- History of Malignant Hipertemia
- Laparosocopy surgery ≥ 120 min
- Temperature previous surgery over 38ºC
- Taking chronic steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Osakidetzalead
Study Sites (1)
Hospital de Galdakao
Galdakao, Vizcaya, 48960, Spain
Related Publications (2)
Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
PMID: 19137809BACKGROUNDEshraghi 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.
PMID: 25045862BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
unai ortega
Osakidetza
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 28, 2015
First Posted
July 29, 2015
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
December 1, 2018
Last Updated
September 27, 2016
Record last verified: 2015-08
Data Sharing
- IPD Sharing
- Will share