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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02511080
Enrollment
70
Registered
2015-07-29
Start date
2016-07-31
Completion date
2018-12-31
Last updated
2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

Keywords

Spot-on; perioperative hypothermia.

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.

Interventions

DEVICESpot-On

use of active hot measures

Sponsors

Osakidetza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
change in the Body Core Temperaturemeasure every 15 minutes since the patient arrive to operating room until is derivated to recovery room, an average of 3 hoursmeasure the body core temperature by Spoton device when the patient arrive to operating room

Secondary

MeasureTime frameDescription
incidence of blood transfusionIn the first two weeks after being operated.Transfusion if hemoglobin lower than 7 mgr/dl
surgical wound infectionwhile the patient stay in the hospital, an average of two weeksthe surgeon determines the infection of the surgical wound

Countries

Spain

Contacts

Primary Contactunai ortega
unaiortegamera@gmail.com0034
Backup ContactSaioa Riaño
saioa.riañoonaindia@osakidetza.eus0034

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026