HypothermiaNCT02511080
Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
A study testing Spot-On in people with Hypothermia, run by Osakidetza at 1 site in Spain.
Trial summary
Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothermia
- What is being tested?
- Spot-On
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients that need a colorrectal laparoscopic surgery
Who cannot join
- Use of antagonist of Calcium
- Alergy to medications
- History of Malignant Hipertemia
- Laparosocopy surgery ≥ 120 min
- Temperature previous surgery over 38ºC
- Taking chronic steroids
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Galdakao
Galdakao, Vizcaya, 48960
unai Ortega, 0034, unai.ortegamera@gmail.com
saioa Riaño, 0034, saioa.riañoonaindia@osakidetza.eus
About this study
Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.
Read the 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.
- Conditions
- Hypothermia
- Being tested
- Spot-On
- Keywords
- Spot-on; perioperative hypothermia.
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spot-OnDevice
use of active hot measures
| Study group | Role | What they receive |
|---|---|---|
| Spot-on group | Active comparator | Use active measures against intraoperative hypothermia Receives: Device: Spot-On |
| control | No intervention | standard measures against intraoperative hipothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Body Core Temperature
measure the body core temperature by Spoton device when the patient arrive to operating room
Measured: 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
Transfusion if hemoglobin lower than 7 mgr/dl
Measured: In the first two weeks after being operated.
surgical wound infection
the surgeon determines the infection of the surgical wound
Measured: while the patient stay in the hospital, an average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osakidetza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Unai Ortega Mera, Osakidetza
- Investigators
- unai ortega, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511080
- Sponsor's protocol ID
- CEIC 16/2015
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
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.
PubMed 19137809Eshraghi 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.
PubMed 25045862
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
- ClinicalTrials.gov ID
- NCT02511080
- Acronym / sponsor ID
- CEIC 16/2015
- Conditions
- Hypothermia
- Keywords
- Spot-on; perioperative hypothermia.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- OsakidetzaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spot-on group | Active comparator | Device: Spot-OnUse active measures against intraoperative hypothermia |
| control | No intervention | –standard measures against intraoperative hipothermia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients that need a colorrectal laparoscopic surgery
Key exclusion criteria (6 listed)
- Use of antagonist of Calcium
- Alergy to medications
- History of Malignant Hipertemia
- Laparosocopy surgery ≥ 120 min
- Temperature previous surgery over 38ºC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spot-Onuse of active hot measures | Device | Spot-on group |
Primary outcome
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
2 secondary outcomes
incidence of blood transfusion
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 19137809Torossian 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.
- Background: PubMed 25045862Eshraghi 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.
- Individual participant dataSharing planned: Yes
Related trials for Hypothermia
Not yet recruiting
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
unai ortega principal investigator
Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spot-On in people with Hypothermia, run by Osakidetza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact unai ortega (0034, unaiortegamera@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511080, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.