Assessing Fluid Responsiveness With PWTT

NCT03280953 | Completed

• 1 other identifier: 837.004.16
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluid Therapy; Monitoring, Intraoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (5)

• Heart rate before and after fluid bolus

  1 day

• Blood pressure before and after fluid bolus

  1 day

• Flow Time corrected before and after fluid bolus

  1 day

• Stroke volume before and after fluid bolus

  1 day

• Pulse Pressure Variation before and after fluid bolus

  1 day

Interventions

Assessing fluid responsiveness by PWTT value DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled for elective open abdominal surgery

You may qualify if:

• Adults 18 - 80 years old
• elective open abdominal surgery
• clinical indication for direct arterial blood pressure Monitoring
• supine Position intraoperatively

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

University Medical Center of Johannes Gutenberg University

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related 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.

  PMID: 20376431 BACKGROUND

Study Officials

• Kimiko Fukui-Dunkel, M.D., Ph.D.

  University Medical Center of Johannes Gutenberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Anesthesiology

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: September 13, 2017
• Study Start: May 31, 2016
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)