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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02511080
• Other study ID #: CEIC 16/2015
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2015
• Last updated: September 26, 2016
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2015
• Source: Osakidetza
• Contact: unai ortega
• Phone: 0034
• Email: unaiortegamera[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

Device:
• Spot-On
use of active hot measures

Locations

Country	Name	City	State
Spain	Hospital de Galdakao	Galdakao	Vizcaya

Sponsors (1)

Lead Sponsor	Collaborator
Osakidetza

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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):543-9. doi: 10.1213/ANE.0000000000000319. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the Body Core Temperature	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	Yes
Secondary	incidence of blood transfusion	Transfusion if hemoglobin lower than 7 mgr/dl	In the first two weeks after being operated.	Yes
Secondary	surgical wound infection	the surgeon determines the infection of the surgical wound	while the patient stay in the hospital, an average of two weeks	Yes