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

O

Osakidetza

Status

Unknown

Conditions

Hypothermia

Treatments

Device: Spot-On

Study type

Interventional

Funder types

Other

Identifiers

NCT02511080
CEIC 16/2015

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Spot-on group
Active Comparator group
Description:
Use active measures against intraoperative hypothermia
Treatment:
Device: Spot-On
control
No Intervention group
Description:
standard measures against intraoperative hipothermia

Trial contacts and locations

1

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Central trial contact

unai ortega; Saioa Riaño

Data sourced from clinicaltrials.gov

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