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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32532

Enrollment

111

Registered

2008-11-12

Start date

2008-12-10

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Hemodynamiek in de perioperatieve periode Hemodynamic alterations in the perioperative period

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Group A (Patients undergoing cardiothoracic surgery) * Emergency operation * Body mass index (BMI) 15 35 * Diabetes mellitus Group B (Volunteers) * Body mass index (BMI) 15 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 35 * Use of beta blockers or anti-hypertensive drugs * Use of diuretics * Diabetes mellitus

Design outcomes

Primary

Measure	Time frame
* Correlation between cardiac output (CO) derived from thermodilution method and CO as calculated by Nexfin (Objective I) * Pressure drop during Valsalva maneuver of 20 mmHg (Objective II). * PPV drop of 7.5% due to fluid redistribution in the postoperative period as compared to the preoperative PPV (Objective III)	—

Secondary

Measure	Time frame
* Pulse pressure variation (PPV): The percentage change of the pulse pressure during the breathing/respiratory ventilation cycle. * Continuous blood pressure (CBP) * Stroke volume variation (SVV): The percentage change between the maximal and minimal stroke volumes (SV) divided by the average of the minimum and maximum over a floating period of 30 seconds. * Fluid balance * Demographic patient variables: age, sex, weight, length, comorbidities. * Surgical patient variables: fluid therapy, number of blood transfusions	—

Measure

Time frame

* Pulse pressure variation (PPV): The percentage change of the pulse pressure during the breathing/respiratory ventilation cycle. * Continuous blood pressure (CBP) * Stroke volume variation (SVV): The percentage change between the maximal and minimal stroke volumes (SV) divided by the average of the minimum and maximum over a floating period of 30 seconds. * Fluid balance * Demographic patient variables: age, sex, weight, length, comorbidities. * Surgical patient variables: fluid therapy, number of blood transfusions

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Countries

Netherlands

Outcome results