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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05185141
Enrollment
84
Registered
2022-01-11
Start date
2022-01-11
Completion date
2026-07-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

Keywords

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

Brief 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.

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).

Interventions

None listed

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in stroke volume following a fluid bolus.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.

Countries

Germany

Contacts

CONTACTJohannes M Wirkus, M.D.
johannes.wirkus@unimedizin-mainz.de+49 6131 17- 7175
STUDY_CHAIRGunther J Pestel, M.D., Ph.D.

Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology

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

Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026