Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Men

Study Overview
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Brief Summary
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The objective of this randomized, controlled single blind study is to compare pulse wave and blood pressure measurements before, during and after exercise ergometry in healthy male subjects.

Detailed Description
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In a randomized single-blind study design the investigators explore how well blood pressure parameters calculated using a Pulse Transit Time-based method (device: SOMNOtouchTM RESP) match blood pressure parameters measured by a classic upper arm blood pressure cuff (Mobil-O-Graph® PWA) under standardized load conditions (ergometry). In 30 healthy male subjects (age 18 - 40 years), cardiovascular parameters before, during and after a standardized load on a bicycle ergometer (half-lying position) are recorded with three different devices (Mobil-O-Graph® PWA versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100) and compared. Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases. The Mobil-O-Graph® PWA blood pressure cuff is applied randomized to the arm with the previously determined higher or lower systolic blood pressure mean difference. The subjects are blinded to the results of the measurements during ergometry. After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest period. Measurements are taken every two minutes with the Mobil-O-Graph® PWA; data acquisition with the SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a total duration of 72 minutes.

Official Title
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Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Male Subjects - a Randomized, Controlled, Single-blind Study

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Other: Ergometry H
* Other: Ergometry L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Healthy at the time of the examinations Inconspicuous anamnesis regarding cardiovascular diseases and bronchial asthma resting heart rate 50 to 100 beats per minute Normal blood pressure or appropriately treated and controlled hypertension (systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg) Exclusion Criteria: Acute or chronic (especially cardiovascular) diseases, including cardiac arrhythmia and vegetative regulatory disorders (recorded via anamnesis) Taking allopathic medication: digitalis, beta blockers, antiarrhythmics Bronchial asthma (recorded by anamnesis) Alcohol abuse Heart diseases NYHA class IV Blood pressure side difference ≥ 10mmHg Fever (> 37,5°C)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Higher Blood Pressure<br>Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H | Other: Ergometry H<br>* After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period. Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure (reference parameter). SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined lower systolic blood pressure.<br>|
| Experimental: Lower Blood Pressure<br>Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L | Other: Ergometry L<br>* After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period. Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure (reference parameter). SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined higher systolic blood pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of the systolic blood pressure | Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ReflectionIndex (GeTeMed Vitaguard 3100) | ReflectionIndex measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| TimeTX (GeTeMed Vitaguard 3100) | TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| TimeTY (GeTeMed Vitaguard 3100) | TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| QuotTYTX (GeTeMed Vitaguard 3100) | QuotTYTX measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| AreaAX (GeTeMed Vitaguard 3100) | AreaAX measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| AreaAY (GeTeMed Vitaguard 3100) | AreaAY measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| QuotAYAX (GeTeMed Vitaguard 3100) | QuotAYAX measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| AreaAV (GeTeMed Vitaguard 3100) | AreaAV measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| AreaAW (GeTeMed Vitaguard 3100) | AreaAW measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| QuotAWAV (GeTeMed Vitaguard 3100) | QuotAWAV measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| QuotTVTW (GeTeMed Vitaguard 3100) | QuotTVTW measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| TimeTV (GeTeMed Vitaguard 3100) | TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| TimeTW (GeTeMed Vitaguard 3100) | TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| MinT1 (GeTeMed Vitaguard 3100) | Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| MinT2 (GeTeMed Vitaguard 3100) | Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| MaxT1 (GeTeMed Vitaguard 3100) | Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| MaxT2 (GeTeMed Vitaguard 3100) | Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| QuotHRRespRate (GeTeMed Vitaguard 3100) | Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Diastolic Blood Pressure (SOMNOtouchTM RESP) | Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Mean Arterial Blood Pressure (SOMNOtouchTM RESP) | Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Pulse Pressure (SOMNOtouchTM RESP) | Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Heartrate (SOMNOtouchTM RESP) | Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Oxygen saturation (SpO2, SOMNOtouchTM RESP) | Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Pulse-Transit-Time (PTT, SOMNOtouchTM RESP) | Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Systolic Blood Pressure measured with the device Mobil-O-Graph® PWA | Systolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWA | Diastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWA | Mean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Pulse Pressure measured with the device Mobil-O-Graph® PWA | Pulse Pressure (mmHg) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Heartrate (Mobil-O-Graph® PWA) | Heartrate (beats per minute, bpm) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Puls Pressure Amplification (Mobil-O-Graph® PWA) | Puls Pressure Amplification measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Stroke Volume (Mobil-O-Graph® PWA) | Stroke Volume (ml) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Cardiac output (Mobil-O-Graph® PWA) | Cardiac output (l/min) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Vascular Resistance (Mobil-O-Graph® PWA) | Vascular Resistance (s*mmHg/ml) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Cardiac Index (Mobil-O-Graph® PWA) | Cardiac Index (l/min*1/m2) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Augmentation Pressure (Mobil-O-Graph® PWA) | Augmentation Pressure (mmHg) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Reflection Coefficient (Mobil-O-Graph® PWA) | Reflection Coefficient (%) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Pulse Wave Velocity (PWV) (Mobil-O-Graph® PWA) | Pulse Wave Velocity (PWV, m/s) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Systole Time (Mobil-O-Graph® PWA) | Systole Time (s) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Tmax-forward (Mobil-O-Graph® PWA) | Tmax-forward (s) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Tmax-backward (Mobil-O-Graph® PWA) | Tmax-backward (s) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Forward Pressure (Mobil-O-Graph® PWA) | Forward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Backward Pressure (Mobil-O-Graph® PWA) | Backward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Pulse Transit Time (GeTeMed Vitaguard 3100) | Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Perfusion Index (GeTeMed Vitaguard 3100) | Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100) | Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| SlopeInW1 (GeTeMed Vitaguard 3100) | SlopeInW1 measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| SlopeInW2 (GeTeMed Vitaguard 3100) | SlopeInW2 measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| SlopeInW3 (GeTeMed Vitaguard 3100) | SlopeInW3 measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| SlopeInW4 (GeTeMed Vitaguard 3100) | SlopeInW4 measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 
| StiffnessIndex (GeTeMed Vitaguard 3100) | StiffnessIndex measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular parameters, Blood Pressure, Pulse Wave, Ergometry, MobiloGraph, Somnotouch