Fluid TherapyNCT03280953
Assessing Fluid Responsiveness With PWTT
An observational study of Fluid Therapy and Monitoring, Intraoperative, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Therapy, Monitoring, Intraoperative
- What is being tested?
- Assessing fluid responsiveness by PWTT value
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2016to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled for elective open abdominal surgery
Who may be able to join
- Adults 18 - 80 years old
- elective open abdominal surgery
- clinical indication for direct arterial blood pressure Monitoring
- supine Position intraoperatively
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of Johannes Gutenberg University
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Finding the Cut-off Value of Pulse Wave Transit Time (PWTT) to Estimate the Fluid Responsibility
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.
Read the detailed 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.
- 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.
- The end of pulse wave duration can be assessed by peripheral plethysmography mostly from a finger tip but also from an ear lobe.
- The pulse wave time can be simply measured as it is, but can also be adjusted by heart rate using Bazett-Formula.
- Not only the simple PWTT but also ventilatory induced fluctuation of PWTT (ΔPWTT) may be used for predicting fluid responsiveness.
- Conditions
- Fluid Therapy, Monitoring, Intraoperative
- Being tested
- Assessing fluid responsiveness by PWTT value
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing fluid responsiveness by PWTT valueDiagnostic test
PWTT value will be analysed to find the cutoff values compared by esophageal doppler and pulse pressure variation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (ΔPWTT) will be computed.
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start31 May 2016
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunther Pestel MD, PhD, Johannes Gutenberg University Mainz
- Investigators
- Kimiko Fukui-Dunkel, M.D., Ph.D., Principal investigator, University Medical Center of Johannes Gutenberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280953
- Sponsor's protocol ID
- 837.004.16
- Status last verified
- Jul 2020
- First submitted
- 25 Apr 2017
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20376431
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding the Cut-off Value of Pulse Wave Transit Time (PWTT) to Estimate the Fluid Responsibility
- ClinicalTrials.gov ID
- NCT03280953
- Acronym / sponsor ID
- 837.004.16
- Conditions
- Fluid Therapy, Monitoring, Intraoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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.
- The end of pulse wave duration can be assessed by peripheral plethysmography mostly from a finger tip but also from an ear lobe.
- The pulse wave time can be simply measured as it is, but can also be adjusted by heart rate using Bazett-Formula.
- Not only the simple PWTT but also ventilatory induced fluctuation of PWTT (ΔPWTT) may be used for predicting fluid responsiveness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for elective open abdominal surgery
Key inclusion criteria (4 listed)
- Adults 18 - 80 years old
- elective open abdominal surgery
- clinical indication for direct arterial blood pressure Monitoring
- supine Position intraoperatively
Key exclusion criteria (12 listed)
- under 18 years, over 80 years old
- pregnant
- no informed consent
- systemic inflammatory response syndrome (SIRS) or Sepsis
- Severe cardiac, coronary or vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessing fluid responsiveness by PWTT valuePWTT value will be analysed to find the cutoff values compared by esophageal doppler and pulse pressure variation. | Diagnostic test | – |
Primary outcome
PWTT change before and after fluid bolus
Time frame: 1 day
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 (ΔPWTT) will be computed.
5 secondary outcomes
Heart rate before and after fluid bolus
Time frame: 1 day
Blood pressure before and after fluid bolus
Time frame: 1 day
Flow Time corrected before and after fluid bolus
Time frame: 1 day
Stroke volume before and after fluid bolus
Time frame: 1 day
Pulse Pressure Variation before and after fluid bolus
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 20376431Rhodes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimiko Fukui-Dunkel, M.D., Ph.D. principal investigator
University Medical Center of Johannes Gutenberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Therapy and Monitoring, Intraoperative, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PWTT change before and after fluid bolus (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.