Feasibility study to measure Thermal Indicator Dilution Curves with a photonic sensor in human volunteers

Conditions: cardiovasculaire monitoring
Cardiac Output
Circulating Blood Volume
10019280
10007593

Registration Number: NL-OMON56328

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

have an age of 18 years or older
have signed informed consent
be health, demonstrated by the use of apre-operative anesthesiology
questionnaire

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
any contraindication to multiple injections of 10 ml cold (approx 4 degrees
Celsius) 0.9 % saline intravenously
any contraindication to position a sensor nasally (for 15 minutes)
incapable of understanding the language in which the information is given.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary hypotheses to be tested are:<br /><br>(1) a reproducible 1st thermal IDC,<br /><br>(2) at least 1 recirculation thermal IDC<br /><br>can be measured with the FBG photonic sensor in both the peripheral and nasal<br /><br>position after a single injection of 10 ml cold (approx 4 degrees Celsius) 0.9<br /><br>% saline intravenously.<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary hypotheses to be tested are:<br /><br>- there is a linear correlation between (the change) of the area under the<br /><br>curve of the primary thermal IDC measured by the FBG photonic sensor, with the<br /><br>change of the Stroke Volume and Cardiac Output measured by a validated<br /><br>non-invasive measurement in three positions of the Tilt-Table Test;<br /><br>- when there is an impact of external temperature differences (of inhaled air)<br /><br>on the thermal IDC measured by the FBG photonic sensor, respiratory and pulse<br /><br>rate signals can be derived from the 1st thermal IDC measured by the FBG<br /><br>photonic sensor;<br /><br>- when there is an impact of external temperature differences (of inhaled air)<br /><br>on the thermal IDC measured by the FBG photonic sensor, respiratory and pulse<br /><br>rate signals can be derived from the 1st thermal IDC measured by the FBG<br /><br>photonic sensor; </p><br>