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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2020
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

PWTT is determined by measuring the beginning and the end of pulse wave duration and can be calculated as the time interval from the ECG R-wave peak to the rise point of the pulse oximeter wave.

it consists of two components: pre ejection period (PEP) and arterial pulse wave transit time (a-PWTT). PEP is defined as the time from the ECG R wave to the rise point of the aortic root pressure wave. a-PWTT is defined as the time from the rise point of the aortic pressure wave to the rise point of the pulse oximeter wave. a-PWTT is the component which is directly related to the velocity of the pulse wave. However noninvasively, we can measure only PWTT, which also includes PEP. In general, PEP change over short periods of time is negligible in most cases, so we can assume that PWTT corresponds to

a-PWTT. In studies using several studies using animals and healthy volunteers, PWTT showed good correlation with stroke volume or systolic blood pressure. Also in experimental and clinical setting, it is shown that PEP changes indicate change in preloads.

It is not known at this moment, which of the following factors to be considered in processing raw data to acquire accurate PWTT value on predicting fluid responsiveness.

1. The beginning of pulse wave can be assessed by the appearance of either Q wave, which represents the initial phase of depolarisation going through the interventricular septum or R wave, which represents the ventricular depolarisation in ECG.

2. The end of pulse wave duration can be assessed by peripheral plethysmography mostly from a finger tip but also from an ear lobe.

3. The pulse wave time can be simply measured as it is, but can also be adjusted by heart rate using Bazett-Formula.

4. Not only the simple PWTT but also ventilatory induced fluctuation of PWTT (ΔPWTT) may be used for predicting fluid responsiveness.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Assessing fluid responsiveness by PWTT value
PWTT value will be analysed to find the cutoff values compared by esophageal doppler and pulse pressure variation.

Locations

Country Name City State
Germany University Medical Center of Johannes Gutenberg University Mainz Rheinland-Pfalz

Sponsors (1)

Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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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