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

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04952649
Collaborator
(none)
50
1
17.8
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker:a Prospective Study
    Actual Study Start Date :
    Jul 7, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    pacemaker dependent patients after cardiac surgery

    Pacemakers are widely used in cardiotomy patients, while it's common that the patients happen to be pacemaker dependent. When the doctor decides to set the heart rate of the pacemaker, we record the hemodynamic parameters and peripheral perfusion index from 70-80-90-100-110 bpm.

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac output [During the study procedure]

      Measurement of cardiac output by Flotrac ,the metric is L/min.

    2. stroke volume [During the study procedure]

      Measurement of stroke volume by Flotrac ,the metric is ml.

    3. Peripheral perfusion index [During the study procedure]

      Measurement of Peripheral perfusion index by masimo radical.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Hospital, Fudan University Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

    • Study Director: Zhe Luo, MD PhD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT04952649
    Other Study ID Numbers:
    • PITCH
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shanghai Zhongshan Hospital

    Study Results

    No Results Posted as of Jul 15, 2021