Assessing Fluid Responsiveness With PWTT

NCT ID: NCT03280953

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fluid Therapy Monitoring, Intraoperative

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Assessing fluid responsiveness by PWTT value

PWTT value will be analysed to find the cutoff values compared by esophageal doppler and pulse pressure variation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Gunther Pestel MD, PhD

Consultant of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kimiko Fukui-Dunkel, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center of Johannes Gutenberg University

Locations

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University Medical Center of Johannes Gutenberg University

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 20376431 (View on PubMed)

Other Identifiers

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837.004.16

Identifier Type: -

Identifier Source: org_study_id

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