Fluid Therapy Clinical Trial
Official title:
Finding the Cut-off Value of Pulse Wave Transit Time (PWTT) to Estimate the Fluid Responsibility
NCT number | NCT03280953 |
Other study ID # | 837.004.16 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2016 |
Est. completion date | January 31, 2019 |
Verified date | July 2020 |
Source | Johannes Gutenberg University Mainz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Pulse wave Transit time (PWTT) is a parameter calculated from ECG and pulseoximeter. It is supposed to help assessing the preload Status and guide intraoperative fluid therapy. This Project aims to validate the benefit of PWTT assessment in an observational clinical fluid study. In case of hypovolemia, patients will receive a fluid Bolus and hemodynamic data from clinical Standard Monitoring, esophageal doppler and PWTT will be recorded before and after the fluid Bolus. Receiver operating characteristic (ROC) curve will be used to determine the validity of PWTT as indicator for fluid responsiveness and its cut off value.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Adults 18 - 80 years old - elective open abdominal surgery - clinical indication for direct arterial blood pressure Monitoring - supine Position intraoperatively Exclusion Criteria: - under 18 years, over 80 years old - pregnant - no informed consent - systemic inflammatory response syndrome (SIRS) or Sepsis - Severe cardiac, coronary or vascular disease - Arrythmia - Cardiac valves anomaly - BMI > 35 - American Society of Anesthesiologists (ASA) physical status classification system: 4 - Lung disease that excludes Ventilation with a tidal volume >8ml/kg - esophageal pathology - planned prone position surgery |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center of Johannes Gutenberg University | Mainz | Rheinland-Pfalz |
Lead Sponsor | Collaborator |
---|---|
Johannes Gutenberg University Mainz |
Germany,
Rhodes A, Cecconi M, Hamilton M, Poloniecki J, Woods J, Boyd O, Bennett D, Grounds RM. Goal-directed therapy in high-risk surgical patients: a 15-year follow-up study. Intensive Care Med. 2010 Aug;36(8):1327-32. doi: 10.1007/s00134-010-1869-6. Epub 2010 Apr 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PWTT change before and after fluid bolus | PWTT recorded before and 1 minute after fluid bolus of 7ml/kg intraoperatively. PWTT values will be calculated: defining PWTT start by either Q-wave or R-wave, defining PWTT end at arrival of the plethysmographic signal either at the finger tip or at the ear lobe, defining PWTT length by either simple measurement or adjusted by the Bazett-Formula. Additionally, as a dynamic parameter respiratory variation of PWTT (?PWTT) will be computed. | 1 day | |
Secondary | Heart rate before and after fluid bolus | Heart rate (in beats per minute), derived from intraoperative standard monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus. | 1 day | |
Secondary | Blood pressure before and after fluid bolus | Systolic blood pressure/diastolic blood pressure/mean arterial pressure (in millimeters of mercury), derived from intraoperative standard monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus. | 1 day | |
Secondary | Flow Time corrected before and after fluid bolus | Flow Time corrected (in milliseconds) measured by esophageal doppler. This hemodynamic parameter will be measured before and 1min after fluid bolus. | 1 day | |
Secondary | Stroke volume before and after fluid bolus | Stroke volume (in milliliters per heartbeat) measured by esophageal doppler. This hemodynamic parameter will be measured before and 1min after fluid bolus. | 1 day | |
Secondary | Pulse Pressure Variation before and after fluid bolus | Pulse Pressure Variation (as percentage) assessed using arterial pressure monitoring. This hemodynamic parameter will be measured before and 1min after fluid bolus. | 1 day |
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