Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences

NCT ID: NCT02511080

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-12-31

Brief Summary

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Using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.

Detailed Description

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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

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Spot-on group

Use active measures against intraoperative hypothermia

Group Type ACTIVE_COMPARATOR

Spot-On

Intervention Type DEVICE

use of active hot measures

control

standard measures against intraoperative hipothermia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spot-On

use of active hot measures

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osakidetza

OTHER

Sponsor Role lead

Responsible Party

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Unai Ortega Mera

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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unai ortega

Role: PRINCIPAL_INVESTIGATOR

Osakidetza

Locations

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Hospital de Galdakao

Galdakao, Vizcaya, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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unai ortega

Role: CONTACT

Saioa Riaño

Role: CONTACT

Facility Contacts

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unai Ortega

Role: primary

saioa Riaño

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 19137809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25045862 (View on PubMed)

Other Identifiers

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CEIC 16/2015

Identifier Type: -

Identifier Source: org_study_id

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