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Clinical feasibility and performance of a continuous finger blood pressure measurement device in the perioperative period

Completed
Conditions
Hemodynamiek in de perioperatieve periode
Hemodynamic alterations in the perioperative period
Registration Number
NL-OMON32532
Lead Sponsor
Vrije Universiteit Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
111
Inclusion Criteria

Group A (Patients undergoing cardiothoracic surgery)
* Patients undergoing elective cardiothoracic surgery
* Use of a pulmonary artery catheter (PAC)
* Age 18-75 years
* Maximal ICU stay of 24 hours
* Informed consent
Group B (Volunteers)
* Males
* Healthy subjects
* Age 18-50 years
* Informed consent
Group C (Patients undergoing elective abdominal surgery)
* Patients undergoing elective abdominal surgery
* Age 18-75 years
* Informed consent

Exclusion Criteria

Group A (Patients undergoing cardiothoracic surgery)
* Emergency operation
* Body mass index (BMI) 15 < BSA > 35
* Diabetes mellitus
Group B (Volunteers)
* Body mass index (BMI) 15 < BSA > 35
* Underlying cardiovascular diseases
* Use of beta blockers or anti-hypertensive drugs
* Use of diuretics
* Diabetes mellitus
* Use of coffee or cigarettes before the measurements take place
Group C (Patients undergoing elective abdominal surgery)
* Body mass index (BMI) 15 < BSA > 35
* Use of beta blockers or anti-hypertensive drugs
* Use of diuretics
* Diabetes mellitus

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>* Correlation between cardiac output (CO) derived from thermodilution method<br /><br>and CO as calculated by Nexfin (Objective I)<br /><br>* Pressure drop during Valsalva maneuver of 20 mmHg (Objective II).<br /><br>* PPV drop of 7.5% due to fluid redistribution in the postoperative period as<br /><br>compared to the preoperative PPV (Objective III)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>* Pulse pressure variation (PPV): The percentage change of the pulse pressure<br /><br>during the breathing/respiratory ventilation cycle.<br /><br>* Continuous blood pressure (CBP)<br /><br>* Stroke volume variation (SVV): The percentage change between the maximal and<br /><br>minimal stroke volumes (SV) divided by the average of the minimum and maximum<br /><br>over a floating period of 30 seconds.<br /><br>* Fluid balance<br /><br>* Demographic patient variables: age, sex, weight, length, comorbidities.<br /><br>* Surgical patient variables: fluid therapy, number of blood transfusions</p><br>
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