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

Feasibility study to measure Thermal Indicator Dilution Curves with a photonic sensor in human volunteers - Photonic registration of Thermal Indicator Dilution Curves (IDC) in man.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56328

Enrollment

Registered

2023-10-16

Start date

2023-11-01

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

cardiovasculaire monitoring Cardiac Output Circulating Blood Volume

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results