Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370676
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-11
Brief Title:
Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location
Sponsor:
Institute of Mountain Emergency Medicine
Organization:
Institute of Mountain Emergency Medicine
Study Overview
Official Title:
Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESO-TIP
Brief Summary:
Background An accurate measurement of the core body temperature CBT is of pivotal importance in the management of severely hypothermic patients For instance triage decisions for or against extracorporeal rewarming of hypothermic patients in cardiac arrest strongly depend on CBT CBT measurement with an oesophageal probe is currently considered the gold standard in hypothermic patients with a secured airway in the prehospital setting with the tip of the probe placed into the distal third of the oesophagus ie posteriorly to the heart and distal to the tracheal bifurcation However the correct placement of the probe tip cannot be verified in the prehospital setting and it is unknown how incorrect placement affects temperature readings
Hypothesis and aim The investigators hypothesise that an incorrect placement of the oesophageal temperature probe tip could lead to inaccurate measurements ie temperature readings not reflecting the real CBT Particularly a tip location too high in the oesophagus in close proximity to the trachea could lead to falsely low temperature readings especially when the patient is ventilated with cold air The aim of the proposed study is to investigate the influence of oesophageal temperature probe tip location on CBT measurement
Methods Experimental interventional study on 16 healthy volunteers During the test oesophageal temperature is measured while participants are breathing ambient air first at 20C baseline followed by cold -20C ambient air in supine position for 20 minutes each test in an environmental simulator terraXcube Each participant repeats the 20-min test two times with the oesophageal temperature probe tip placed either in the lower third of the oesophagus ie correct position or too high in the oesophagus ie behind the trachea
Hypothesis and aim The investigators hypothesise that an incorrect placement of the oesophageal temperature probe tip could lead to inaccurate measurements ie temperature readings not reflecting the real CBT Particularly a tip location too high in the oesophagus in close proximity to the trachea could lead to falsely low temperature readings especially when the patient is ventilated with cold air The aim of the proposed study is to investigate the influence of oesophageal temperature probe tip location on CBT measurement
Methods Experimental interventional study on 16 healthy volunteers During the test oesophageal temperature is measured while participants are breathing ambient air first at 20C baseline followed by cold -20C ambient air in supine position for 20 minutes each test in an environmental simulator terraXcube Each participant repeats the 20-min test two times with the oesophageal temperature probe tip placed either in the lower third of the oesophagus ie correct position or too high in the oesophagus ie behind the trachea
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None