Impact of Forced Air Warming on Perioperative Thermodynamics

NCT03191214 | Unknown FDA Device

• 1 other identifier: 228666
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the temperature changes that take place throughout the body in a real world setting, when a patient is given general anaesthesia. Specifically we will investigate the movement of body heat from the core to the peripheries at the beginning of surgery. This will be measures with a series of temperature sensors and infrared thermography

Conditions

Hypothermia Following Anesthesia

Keywords

Infra-red thermography

Outcome Measures

Primary Outcomes (1)

• The change in core - peripheral temperature gradient

  This will be calculated as the sum of, the increase in peripheral temperature and the decrease in core temperature, between 0 and 25 minutes from the induction of anaesthesia. Peripheral temperature will be determined by segmental thermal analysis of thermography data, calibrated against skin temperature sensors.

  At 25 minutes following induction of anaesthesia

Secondary Outcomes (2)

• Peripheral to core heat transfer due to warming

  Between 60 minutes and 120 minutes following induction of anaesthesia

• Change in temperature gradient as a function of time & systemic vascular resistance

  For the first 25 minutes following induction of anaesthesia

Study Arms (2)

No Warming

Patients undergoing brief surgical procedures of \>15 minutes for whom no warming devices are being employed.

Forced Air Warming

Patients undergoing surgical procedures in which forced air warming, is being used

Device: Intraoperative Forced Air Warming

Interventions

Intraoperative Forced Air Warming DEVICE

As part of their standard care, patients undergoing surgery \>30 min in duration will receive forced air warming in the form of a Bair Hugger. This is a blanket covering their upper torso and arms into which warm air is blown.

Forced Air Warming

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elective surgical patients

You may qualify if:

• Male \& Female patients, from 18 - 80 years old, undergoing surgery requiring general anaesthesia, who are deemed to have capacity to give informed consent and have done so in writing prior to commencement of surgery.
• The surgeries include :
• brief surgical procedures of \>15 minutes requiring general for whom no warming devices are being employed
• surgical \>30 minutes procedures in which forced air warming, is being used

You may not qualify if:

• Patients who do not adequately understand verbal explanations or written information given in English.
• Patients not possessive of capacity to give informed consent. Patients who have not given consent.
• Patients with :
• Peripheral vascular disease
• BMI \>30
• Aortic aneurysms
• Amputations
• Patients with a history of:
• Thyroid disease
• Dysautonomia
• Malignant hyperthermia

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, NW1 2BU, United Kingdom

Location

Study Officials

• Fintan Hughes

  Univeristy College London Hospital

  STUDY DIRECTOR

Central Study Contacts

Fintan Hughes

CONTACT

+44 7731403686; Fintan.hughes@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 19, 2017
• Study Start: July 21, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)