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

NCT ID: NCT05185141

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2025-04-30

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).

Conditions

Hemodynamic Instability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Johannes M Wirkus, MD

Principal Investigator Johannes Wirkus, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gunther J Pestel, M.D., Ph.D.

Role: STUDY_CHAIR

Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology

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

Role: STUDY_DIRECTOR

Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology

Locations

Department of Anesthesiology, Johannes-Gutenberg University Medical Center

Mainz, Rhineland-Palatinate, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Johannes M Wirkus, M.D.

Role: CONTACT

johannes.wirkus@unimedizin-mainz.de

+49 6131 17- 7175

Facility Contacts

Johannes M Wirkus, M.D.

Role: primary

johannes.wirkus@unimedizin-mainz.de

+49 6131 17-0

References

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.

Reference Type: BACKGROUND

PMID: 26123610 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28363617 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30424730 (View on PubMed)

Other Identifiers

21-02546

Identifier Type: -

Identifier Source: org_study_id