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Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery (TEMP CORE BLOC)

P

Poitiers University Hospital

Status

Completed

Conditions

Major Surgery in Adult Patients

Treatments

Device: Monitoring by oesophagal probe and Spot-on
Device: Monitoring by arterial catheter and Spot-on

Study type

Interventional

Funder types

Other

Identifiers

NCT02869828
TEMPCORE-BLOC

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 2 patient groups

monitoring by arterial catheter and Spot-on
Other group
Treatment:
Device: Monitoring by arterial catheter and Spot-on
monitoring by oesophagus tube and Spot-on
Other group
Treatment:
Device: Monitoring by oesophagal probe and Spot-on

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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