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

NCT05185141 | Recruiting

• 1 other identifier: 21-02546
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Keywords

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

Outcome Measures

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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Anesthesiology, Johannes-Gutenberg University Medical Center

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 26123610 BACKGROUND

• 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.

  PMID: 28363617 BACKGROUND

• 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.

  PMID: 30424730 BACKGROUND

Study Officials

• Gunther J Pestel, M.D., Ph.D.

  Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology

  STUDY CHAIR

• Kimiko Fukui-Dunkel, M.D., Ph.D.

  Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology

  STUDY DIRECTOR

Central Study Contacts

Johannes M Wirkus, M.D.

CONTACT

+49 6131 17- 7175; johannes.wirkus@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Johannes Wirkus, M.D.

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: January 11, 2022
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

DE (1)