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NCT Number: NCT02869828

Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery

Core temperature monitoring is mandatory during major surgery. The accurate techniques currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal temperature (30 patients) and to artery catheter (20 patients) in adult patients during surgery.

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Key information

Conditions

Major Surgery in Adult Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BOISSON Matthieu

Poitiers, 86021, France

About this study

Every patients undergoing heavy surgery had their central temperature monitoring, through an arterial catheter if the surgery required it (30 patients in this arm), otherwise the investigators used an oesophagus tube (20 patients). We also monitored every 50 patients with a non-invasive method 3M spot on (Zero-heath-flux technic) in order to measure its fiability and validity during the surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo general anaesthesia for gut surgery lasting more than 2 hours
  • Patients with core temperature monitored with oesophagal probe only (30 patients) or with oesophagal probe and PICCO device (20 patients)
  • Patients without opposition to this study after informations given

Exclusion criteria

  • Patients with frontal cutaneous decay wich avoid using 3M Spot-on
  • Patients whom oesophagal probe was prohibited (oesophagal varices, oesophagal surgery)
  • Pregnant women or breast-feeding, women who may become pregnant unless adequate contraceptive measures

Treatment and study plan

Monitoring by arterial catheter and Spot-on

Device

Monitoring by oesophagal probe and Spot-on

Device

Primary outcomes

  1. temperature monitoring with Zero-Heath-Flux (SpotOn)

    Time frame: 1 day

  2. temperature monitoring with oesophagal probe (Coviden)

    Time frame: 1 day

  3. temperature monitoring with arterial catheter (PICCO)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: TEMP CORE BLOC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2016
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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