Back to resultsEffectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
Primary Purpose
Hypothermia
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Spot-On
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia focused on measuring Spot-on; perioperative hypothermia.
Eligibility Criteria
Inclusion Criteria:
- All patients that need a colorrectal laparoscopic surgery
Exclusion Criteria:
- Use of antagonist of Calcium
- Alergy to medications
- History of Malignant Hipertemia
- Laparosocopy surgery ≥ 120 min
- Temperature previous surgery over 38ºC
- Taking chronic steroids
Sites / Locations
- Hospital de GaldakaoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Spot-on group
control
Arm Description
Use active measures against intraoperative hypothermia
standard measures against intraoperative hipothermia
Outcomes
Primary Outcome Measures
change in the Body Core Temperature
measure the body core temperature by Spoton device when the patient arrive to operating room
Secondary Outcome Measures
incidence of blood transfusion
Transfusion if hemoglobin lower than 7 mgr/dl
surgical wound infection
the surgeon determines the infection of the surgical wound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02511080
Brief Title
Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
Official Title
Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osakidetza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.
Detailed Description
Take active measures to prevent non-therapeutic hypothermia during the laparoscopic colon surgery. We improve these measures using heat conductive air warm blankets placed under and o over the patient.
Perform monitoring core body temperature every 15 minutes by spot-on device compared with standard nasopharyngeal probe.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
Spot-on; perioperative hypothermia.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spot-on group
Arm Type
Active Comparator
Arm Description
Use active measures against intraoperative hypothermia
Arm Title
control
Arm Type
No Intervention
Arm Description
standard measures against intraoperative hipothermia
Intervention Type
Device
Intervention Name(s)
Spot-On
Intervention Description
use of active hot measures
Primary Outcome Measure Information:
Title
change in the Body Core Temperature
Description
measure the body core temperature by Spoton device when the patient arrive to operating room
Time Frame
measure every 15 minutes since the patient arrive to operating room until is derivated to recovery room, an average of 3 hours
Secondary Outcome Measure Information:
Title
incidence of blood transfusion
Description
Transfusion if hemoglobin lower than 7 mgr/dl
Time Frame
In the first two weeks after being operated.
Title
surgical wound infection
Description
the surgeon determines the infection of the surgical wound
Time Frame
while the patient stay in the hospital, an average of two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients that need a colorrectal laparoscopic surgery
Exclusion Criteria:
Use of antagonist of Calcium
Alergy to medications
History of Malignant Hipertemia
Laparosocopy surgery ≥ 120 min
Temperature previous surgery over 38ºC
Taking chronic steroids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
unai ortega
Phone
0034
Email
unaiortegamera@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saioa Riaño
Phone
0034
Email
saioa.riañoonaindia@osakidetza.eus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
unai ortega
Organizational Affiliation
Osakidetza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Galdakao
City
Galdakao
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
unai Ortega
Phone
0034
Email
unai.ortegamera@gmail.com
First Name & Middle Initial & Last Name & Degree
saioa Riaño
Phone
0034
Email
saioa.riañoonaindia@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
unai ortega
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
19137809
Citation
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.
Results Reference
background
PubMed Identifier
25045862
Citation
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.
Results Reference
background
Learn more about this trial
Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
We'll reach out to this number within 24 hrs