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NCT Number: NCT05185141

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Johannes-Gutenberg University Medical Center

Mainz, Rhineland-Palatinate, 55131, Germany

Location status: Recruiting

Location contact

Johannes M Wirkus, M.D.

CONTACT

[email protected]

+49 6131 17-0

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

  1. Change in stroke volume following a fluid bolus.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes M Wirkus, M.D.

CONTACT

[email protected]

+49 6131 17- 7175

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Assessing Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness During Abdominal Surgery: a Prospective Observational Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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