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RecruitingNCT05185141Updated Jun 10, 2026

Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness

An observational study in Hemodynamic Instability, sponsored by Johannes Gutenberg University Mainz. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Johannes Gutenberg University Mainz · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
84
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to assess respiratory variation of carotid doppler peak velocity (∆CDPV) for prediction of fluid responsiveness during major abdominal surgery.

Read the detailed description

Investigating hemodynamic parameters in a group of 19 ICU-patients with septic shock, respiratory variation of carotid doppler peak velocity (∆CDPV) has been shown to be able to predict fluid responsiveness. For patients receiving so called lung protective ventilation with a tidal volume of 6ml/kg ∆CDPV was superior for prediction of fluid responsiveness when compared to other well established parameters such as pulse pressure variation (∆PP).

Likewise in another study ∆CDPV has been shown to be superior to stroke volume variation (∆SV) for prediction of fluid responsiveness in patients with septic shock when ventilated with a tidal volume of ≥8ml/ kg.

All in all respiratory variation of carotid doppler peak velocity (∆CDPV) seems to be a promising parameter for prediction of fluid responsiveness (Yao et al., BMC Anesthesiology 2018). However, so far clinical studies have been conducted only under a small number of patients mainly in the intensive care unit and/ or under highly specific conditions (e.g. cardiac surgery).

If ∆CDPV is able to predict fluid responsiveness with high accuracy intraoperatively remains unknown. The investigators are therefore conducting this prospective monocentric observational trial to evaluate the performance of ∆CDPV during major abdominal surgery and compare it to validated fluid responsiveness monitoring parameters ∆PP and corrected flow time (fTc).

Following IRB-approval and written informed consent 84 patients scheduled for major abdominal surgery will be enrolled in the study. Stroke volume will be monitored by Esophageal Doppler Monitoring (CardioQ-ODM®, Deltex Medical Ltd, Chichester, UK). In case of hypovolemia a fluid bolus of 7 ml/kg ideal body weight will be administered at the discretion of the attending anesthesiologist. Respiratory variation of carotid doppler peak velocity (∆CDPV) will be monitored before and 1 minute after completion of each fluid bolus using an ultrasound device with a common linear array transducer (Philips ClearVue 350, Philips Medizin Systeme GmbH, Boeblingen, Germany).

02

Conditions studied

  • Hemodynamic Instability

Keywords

  • Fluid Responsiveness
  • Hemodynamic Monitoring
  • Carotid Doppler Peak Velocity
  • Pulse Pressure Variation
  • Fluid Challenge
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Only patients scheduled for major abdominal surgery with an expected high intraoperative fluid turnover will be eligble for the study. Patients with any kind of crdiac arrhythmia, valve diseases, heart failure or carotid stenosis will be excluded from the study to avoid measurement errors and bias for the hemodynamic parameters such as pulse pressure variation, stroke volume and carotid doppler peak velocity.

Inclusion criteria

  • Age 18-80 years
  • written informed consent
  • scheduled major abdominal surgery

Exclusion criteria

Exclusion Criteria:

  • Age \<18 or >80 years
  • pregnancy
  • SIRS or sepsis
  • any kind of cardiac arrhythmia
  • known valve disease
  • known heart failure
  • any kind of known carotid stenosis
  • carotid doppler peak velocity >182 cm/s before baseline measurement (expected stenosis)
  • missing indication for invasive arterial blood pressure monitoring (IBP) not related to the study
  • peripheral artery disease (PAD)
  • BMI > 35 kg/m2
  • intraabdominal hypertension
  • ASA-PSC of 4
  • severe lung disease (e.g. COPD grade 3, fibrosis)
  • esophageal disease of any kind
  • participation in another clinical study
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
84 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Change in stroke volume following a fluid bolus.

    A rise in stroke volume of ≥10% following a fluid bolus of 7ml/kg Ideal Body Weight is considered to reflect fluid responsiveness. Measurements will be assessed through esophageal doppler monitoring.

    Time frame: Immediately before and 1 minute after completion of each fluid bolus.

06

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology, Johannes-Gutenberg University Medical Center
    Mainz, Rhineland-Palatinate 55131, Germany
    Recruiting
07

References and documents

Publications

  • Ibarra-Estrada MA, Lopez-Pulgarin JA, Mijangos-Mendez JC, Diaz-Gomez JL, Aguirre-Avalos G. Respiratory variation in carotid peak systolic velocity predicts volume responsiveness in mechanically ventilated patients with septic shock: a prospective cohort study. Crit Ultrasound J. 2015 Dec;7(1):29. doi: 10.1186/s13089-015-0029-1. Epub 2015 Jun 26. PubMed 26123610 ↗
  • Lu N, Xi X, Jiang L, Yang D, Yin K. Exploring the best predictors of fluid responsiveness in patients with septic shock. Am J Emerg Med. 2017 Sep;35(9):1258-1261. doi: 10.1016/j.ajem.2017.03.052. Epub 2017 Mar 22. PubMed 28363617 ↗
  • Yao B, Liu JY, Sun YB. Respiratory variation in peripheral arterial blood flow peak velocity to predict fluid responsiveness in mechanically ventilated patients: a systematic review and meta-analysis. BMC Anesthesiol. 2018 Nov 13;18(1):168. doi: 10.1186/s12871-018-0635-0. PubMed 30424730 ↗
08

Registry details

Key details

Study ID
NCT05185141
Lead sponsor
Johannes Gutenberg University Mainz
Responsible party
Johannes M Wirkus, MD (Principal Investigator Johannes Wirkus, M.D., Johannes Gutenberg University Mainz) — Principal investigator
First posted
Jan 11, 2022
Start date
Jan 11, 2022
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jun 10, 2026

Study contacts

Johannes M Wirkus, M.D.
Contact
johannes.wirkus@unimedizin-mainz.de
+49 6131 17- 7175
Gunther J Pestel, M.D., Ph.D.
study chair · Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology
Kimiko Fukui-Dunkel, M.D., Ph.D.
study director · Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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