search
Back to results

Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein

Primary Purpose

Pulmonary Embolism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
temporary pacing femoral vein
temporary pacing subclavian vein
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, Temporary Pacing, Femoral Vein, Subclavian Vein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years old or older
  • There is indication for temporary pacing
  • Patients agreed to participate in the clinical trial and sign a written informed consent

Exclusion Criteria:

  • History of pulmonary embolism or deep vein thrombosis
  • Devices existing in vein system
  • Patients who could not receive randomization
  • Severe coagulation disorder
  • Severe liver, kidney dysfunction
  • Mental diseases
  • Pregnancy
  • Patients investigators believed not suitable for enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Femoral Vein

    Subclavian Vein

    Arm Description

    patients receiving temporary pacing via femoral vein

    patients receiving temporary pacing via subclavian vein

    Outcomes

    Primary Outcome Measures

    Percentage of participants suffering from pulmonary embolism

    Secondary Outcome Measures

    Percentage of participants suffering from deep vein thrombosis

    Full Information

    First Posted
    April 21, 2015
    Last Updated
    February 18, 2016
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
    Collaborators
    Suqian People's Hospital, The First People's Hospital of Kunshan, Danyang People's Hospital of Jiangsu Province, Jiangsu Taizhou People's Hospital, Xinghua People's Hospital, Jiangyin People's Hospital, Qidong People's Hospital, Wuxi No. 2 People's Hospital, Nantong No. 1 People's Hospital, Changzhou No.2 People's Hospital, Xuzhou Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, Northern Jiangsu Province People's Hospital, Rugao People's Hospital, Xuzhou Central Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02430207
    Brief Title
    Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein
    Official Title
    Study of Incidence of Pulmonary Embolism During Peroperative Period of Temporary Pacing Via Femoral Vein Versus Subclavian Vein in China
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University
    Collaborators
    Suqian People's Hospital, The First People's Hospital of Kunshan, Danyang People's Hospital of Jiangsu Province, Jiangsu Taizhou People's Hospital, Xinghua People's Hospital, Jiangyin People's Hospital, Qidong People's Hospital, Wuxi No. 2 People's Hospital, Nantong No. 1 People's Hospital, Changzhou No.2 People's Hospital, Xuzhou Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, Northern Jiangsu Province People's Hospital, Rugao People's Hospital, Xuzhou Central Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Temporary pacing via femoral vein is used widely in mainland China, because of its feasibility and simplicity. However, pulmonary embolism often occurred after the procedure. It is not known that whether there was any difference in incidence of pulmonary embolism between via different approaches. This randomized and multi-center study was designed to verify whether temporary pacing via subclavian vein has lower incidence than via femoral vein.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Embolism
    Keywords
    Pulmonary Embolism, Temporary Pacing, Femoral Vein, Subclavian Vein

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    360 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Femoral Vein
    Arm Type
    Experimental
    Arm Description
    patients receiving temporary pacing via femoral vein
    Arm Title
    Subclavian Vein
    Arm Type
    Experimental
    Arm Description
    patients receiving temporary pacing via subclavian vein
    Intervention Type
    Procedure
    Intervention Name(s)
    temporary pacing femoral vein
    Intervention Description
    Temporary pacing via femoral or subclavian vein
    Intervention Type
    Procedure
    Intervention Name(s)
    temporary pacing subclavian vein
    Primary Outcome Measure Information:
    Title
    Percentage of participants suffering from pulmonary embolism
    Time Frame
    12 hours to 7 days after extraction of temporary pacing leads
    Secondary Outcome Measure Information:
    Title
    Percentage of participants suffering from deep vein thrombosis
    Time Frame
    12 hours to 7 days after extraction of temporary pacing leads

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years old or older There is indication for temporary pacing Patients agreed to participate in the clinical trial and sign a written informed consent Exclusion Criteria: History of pulmonary embolism or deep vein thrombosis Devices existing in vein system Patients who could not receive randomization Severe coagulation disorder Severe liver, kidney dysfunction Mental diseases Pregnancy Patients investigators believed not suitable for enrollment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kai Gu, M.D.
    Phone
    0086 25 68136965
    Email
    gukaiwang@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Minglong Chen, M.D.
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    13002611
    Citation
    ZOLL PM. Resuscitation of the heart in ventricular standstill by external electric stimulation. N Engl J Med. 1952 Nov 13;247(20):768-71. doi: 10.1056/NEJM195211132472005. No abstract available.
    Results Reference
    background
    PubMed Identifier
    10814641
    Citation
    Gammage MD. Temporary cardiac pacing. Heart. 2000 Jun;83(6):715-20. doi: 10.1136/heart.83.6.715. No abstract available.
    Results Reference
    background
    PubMed Identifier
    13825713
    Citation
    FURMAN S, SCHWEDEL JB. An intracardiac pacemaker for Stokes-Adams seizures. N Engl J Med. 1959 Nov 5;261:943-8. doi: 10.1056/NEJM195911052611904. No abstract available.
    Results Reference
    background
    PubMed Identifier
    5571275
    Citation
    Cheng TO. Percutaneous transfemoral venous cardiac pacing. A simple and practical method. Chest. 1971 Jul;60(1):73-8. doi: 10.1378/chest.60.1.73. No abstract available.
    Results Reference
    background
    PubMed Identifier
    4697639
    Citation
    Weinstein J, Gnoj J, Mazzara JT, Ayres SM, Grace WJ. Temporary transvenous pacing via the percutaneous femoral vein approach. A prospective study of 100 cases. Am Heart J. 1973 May;85(5):695-705. doi: 10.1016/0002-8703(73)90178-6. No abstract available.
    Results Reference
    background
    PubMed Identifier
    7446387
    Citation
    Pandian NG, Kosowsky BD, Gurewich V. Transfemoral temporary pacing and deep vein thrombosis. Am Heart J. 1980 Dec;100(6 Pt 1):847-51. doi: 10.1016/0002-8703(80)90065-4.
    Results Reference
    background
    PubMed Identifier
    7398027
    Citation
    Nolewajka AJ, Goddard MD, Brown TC. Temporary transvenous pacing and femoral vein thrombosis. Circulation. 1980 Sep;62(3):646-50. doi: 10.1161/01.cir.62.3.646.
    Results Reference
    background
    PubMed Identifier
    15544753
    Citation
    Lopez Ayerbe J, Villuendas Sabate R, Garcia Garcia C, Rodriguez Leor O, Gomez Perez M, Curos Abadal A, Serra Flores J, Larrousse E, Valle V. [Temporary pacemakers: current use and complications]. Rev Esp Cardiol. 2004 Nov;57(11):1045-52. Spanish.
    Results Reference
    background
    PubMed Identifier
    10831950
    Citation
    Klatsky AL, Armstrong MA, Poggi J. Risk of pulmonary embolism and/or deep venous thrombosis in Asian-Americans. Am J Cardiol. 2000 Jun 1;85(11):1334-7. doi: 10.1016/s0002-9149(00)00766-9.
    Results Reference
    background
    PubMed Identifier
    18757870
    Citation
    Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.
    Results Reference
    background

    Learn more about this trial

    Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein

    We'll reach out to this number within 24 hrs