- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511080
Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
September 26, 2016 updated by: Unai Ortega Mera, Osakidetza
Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: unai ortega
- Phone Number: 0034
- Email: unaiortegamera@gmail.com
Study Contact Backup
- Name: saioa Riaño
- Phone Number: 0034
- Email: saioa.riañoonaindia@osakidetza.eus
Study Locations
-
-
Vizcaya
-
Galdakao, Vizcaya, Spain, 48960
- Recruiting
- Hospital de Galdakao
-
Contact:
- saioa Riaño
- Phone Number: 0034
- Email: saioa.riañoonaindia@osakidetza.eus
-
Contact:
- unai Ortega
- Phone Number: 0034
- Email: unai.ortegamera@gmail.com
-
Principal Investigator:
- unai ortega
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Spot-on group
Use active measures against intraoperative hypothermia
|
use of active hot measures
|
NO_INTERVENTION: control
standard measures against intraoperative hipothermia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in the Body Core Temperature
Time Frame: measure every 15 minutes since the patient arrive to operating room until is derivated to recovery room, an average of 3 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of blood transfusion
Time Frame: In the first two weeks after being operated.
|
Transfusion if hemoglobin lower than 7 mgr/dl
|
In the first two weeks after being operated.
|
surgical wound infection
Time Frame: while the patient stay in the hospital, an average of two weeks
|
the surgeon determines the infection of the surgical wound
|
while the patient stay in the hospital, an average of two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: unai ortega, Osakidetza
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (ANTICIPATED)
July 1, 2017
Study Completion (ANTICIPATED)
December 1, 2018
Study Registration Dates
First Submitted
July 28, 2015
First Submitted That Met QC Criteria
July 28, 2015
First Posted (ESTIMATE)
July 29, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 26, 2016
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIC 16/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypothermia
-
The University of Texas Health Science Center,...RecruitingHypothermia; Anesthesia | Hypothermia, Newborn | Hypothermia, SequelaUnited States
-
RECIO PÉREZ, JESÚSUniversity of AlcalaCompletedHypothermia; Anesthesia | Hypothermia Following Anesthesia | Hypothermia Following Anesthesia, Sequela | Hypothermia Due to AnestheticSpain
-
Michael Garron HospitalCompletedHypothermia | Body Temperature Changes | Hypothermia Following Anesthesia | Hypothermia, Accidental | Hypothermia Due to AnestheticCanada
-
Ankara Diskapi Training and Research HospitalCompletedPreventing Hypothermia | Perioperative HypothermiaTurkey
-
Centre Leon BerardCompletedHypothermia | Hypothermia; Anesthesia | Hypothermia, AccidentalFrance
-
Marmara UniversityCompletedHypothermia; Anesthesia | Hypothermia Following AnesthesiaTurkey
-
Marmara UniversityCompletedHypothermia; Anesthesia | Hypothermia Following AnesthesiaTurkey
-
Ciusss de L'Est de l'Île de MontréalCompletedHypothermia Following Anesthesia | Hypothermia, AccidentalCanada
-
Universitat Internacional de CatalunyaRecruitingHypothermia | Hypothermia; Anesthesia | Hypothermia, AccidentalSpain
-
Universitair Ziekenhuis BrusselCompletedChildren | Hypothermia; Anesthesia | Hypothermia Following AnesthesiaBelgium
Clinical Trials on Spot-On
-
Poitiers University HospitalCompletedMajor Surgery in Adult PatientsFrance
-
Kaplan Medical CenterUnknown
-
Thompson Cancer Survival CenterRecruitingHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Head and Neck CarcinomaUnited States
-
Brigham and Women's HospitalCompletedCOVID-19 | Emergencies | Telemedicine | Robotics | Emerging Infectious DiseaseUnited States
-
Kai Medical, Inc.Unknown
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
Beijing HospitalNot yet recruitingCentral Serous Chorioretinopathy
-
National Taiwan University HospitalEnrolling by invitationBiliary Atresia | Cholestasis in Newborn InfantTaiwan
-
University of UlsterCompletedRheumatoid ArthritisUnited Kingdom
-
Lara McKenzieCompleted