Hypovolemia Clinical Trial
— PP3DOfficial title:
PP3D - Prospective Combined Validation of an Algorithm for Measurement of Mean Systemic Filling Pressure and Comparison of Invasively Measured Cardiac Output Versus Cardiac Output Calculated by 3D TOE and Carotid Ultrasound.
Verified date | December 2019 |
Source | Catharina Ziekenhuis Eindhoven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output.
Status | Completed |
Enrollment | 18 |
Est. completion date | August 30, 2019 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Good left and right ventricular ejection fraction - No significant valvular insufficiencies/stenoses - No significant comorbidity - Signed informed consent - Elective coronary artery bypass surgery - Postoperative mechanically ventilated admitted to the PACU Exclusion Criteria: - Withdrawal informed consent - History of pneumonectomy of lobectomy - Mechanical support of circulation - COPD Gold 3 or 4 - Complications during surgery - Postoperative bleeding >50mL/15 minutes after admission to PACU - No thoracic drain in pleura - Postoperative pneumothorax - Participation in other research studies/trials - Elevated intra-abdominal surgery (>12 mmHg) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Catharina Hospital | Eindhoven | North Brabant |
Lead Sponsor | Collaborator |
---|---|
Catharina Ziekenhuis Eindhoven |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical validation of Pms-algorithm | To determine a correlation between Pms calculated by a computerized algorithm by Navigator(TM) (Pms-Nav) and the gold standard for determining Pms: Pms-Insp. The latter is calculated by performing inspiratory breath holds during incremental airway pressure levels thereby simulating a decrease in preload which, by extrapolating a venous return curve, leads to the true Pms when the curve intersects the x-axis (Pms-Insp). | Hours | |
Secondary | Correlation invasive continuous cardiac output and 3D-TOE / carotid artery pulsed wave CO measurement. | Correlation between invasively measured continuous cardiac output (CO) and CO measured by a automated 3D-TOE algorithm and carotid artery PW-measured CO. | Hours |
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