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

Status

Unknown

Conditions

Intervention / Treatment

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 Locations

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
Device: Spot-On
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

Osakidetza

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

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.

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