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

• Sponsor: Osakidetza (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02511080
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypothermia	Device: Spot-On	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Spot-on ™ to Prevent Inadvertent Perioperative Hypothermia and Their Consecuences
• Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: Jul 1, 2017
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. incidence of blood transfusion [In the first two weeks after being operated.]

   Transfusion if hemoglobin lower than 7 mgr/dl

2. surgical wound infection [while the patient stay in the hospital, an average of two weeks]

   the surgeon determines the infection of the surgical wound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Galdakao	Galdakao	Vizcaya	Spain	48960

Sponsors and Collaborators

• Osakidetza

Investigators

• Principal Investigator: unai ortega, Osakidetza

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Unai Ortega Mera, Doctor, Osakidetza
• ClinicalTrials.gov Identifier: NCT02511080
• Other Study ID Numbers: CEIC 16/2015
• First Posted: Jul 29, 2015
• Last Update Posted: Sep 27, 2016
• Last Verified: Aug 1, 2015

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Unai Ortega Mera, Doctor, Osakidetza: Spot-on; perioperative hypothermia.
• Additional relevant MeSH terms: Hypothermia

Study Results

No Results Posted as of Sep 27, 2016