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

Not Applicable

• Conditions: Hypothermia

• Registration Number: NCT02511080
• Lead Sponsor: Osakidetza

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.

Study Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Status Verified: 2015-08
• Study Start: 2016-07
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27
• Primary Completion: 2017-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in the Body Core Temperature	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

Secondary Outcome Measures

Name	Time	Method
incidence of blood transfusion	In the first two weeks after being operated.	Transfusion if hemoglobin lower than 7 mgr/dl
surgical wound infection	while the patient stay in the hospital, an average of two weeks	the surgeon determines the infection of the surgical wound

Trial Locations

Locations (1)

Hospital de Galdakao; 🇪🇸 Galdakao, Vizcaya, Spain