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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02869828

Acronym

TEMP CORE BLOC

Enrollment

Registered

2016-08-17

Start date

2015-06-30

Completion date

2017-01-31

Last updated

2017-06-19

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

Conditions

Major Surgery in Adult Patients

Brief summary

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.

Detailed description

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.

Interventions

DEVICEMonitoring by arterial catheter and Spot-on

DEVICEMonitoring by oesophagal probe and Spot-on

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
temperature monitoring with Zero-Heath-Flux (SpotOn)	1 day
temperature monitoring with oesophagal probe (Coviden)	1 day
temperature monitoring with arterial catheter (PICCO)	1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026