The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker

• Conditions: Pacemaker Dependence

• Registration Number: NCT04952649
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. The peripheral perfusion index (PI) has been considered as an effective parameter evaluating the circulation. In this study, investigators aim to avaluate the ability of peripheral perfusion index to detect changes of hemodynamics in postcardiotomy patients with pacemakers.

Detailed Description

Pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. The peripheral perfusion index (PI) has been considered as an effective parameter evaluating the circulation. In this study, investigators aim to evaluate the ability of peripheral perfusion index to detect changes of hemodynamics (cardiac output or storke volume,et al) in postcardiotomy patients with pacemakers.

Study Timeline

• Study First Submitted: 2021-06-18
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-06
• Study Start: 2021-07-07
• Study First Posted: 2021-07-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-15
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age >=18 years old;
• postcardiotomy
• placement of temportary pacemaker during the surgery
• dependence of pacemaker (abscence of autonomic cardiac rhythm）

Exclusion Criteria

• hemodynamic unstable （high dose of vasoactive drugs）
• fingers ischemia, cannot monitor the peripheral perfusion index

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac output	During the study procedure	Measurement of cardiac output by Flotrac ,the metric is L/min.
Peripheral perfusion index	During the study procedure	Measurement of Peripheral perfusion index by masimo radical.
stroke volume	During the study procedure	Measurement of stroke volume by Flotrac ,the metric is ml.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China