Temporary Transvenous Pacemaker Placement by Intracavitary Electrocardiogram Monitoring

Sponsor
Hunan Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04905199
Collaborator
(none)
60
1
10.3
5.9

Study Details

Study Description

Brief Summary

Traditional temporary pacing catheter insertion by intracavitary electrocardiogram (IC-ECG) monitoring which only monitoring tip polar, the negative one. The investigators modified the technique by monitoring both negative and positive polar which will be precisely locating catheter tip and indicating the direction of the catheter tip.

Extensively used temporary pacing catheter tip has two electrodes which are about 1 cm apart. Distal electrode is negative (-) and active, proximal electrode is positive (+) and indifferent.

Investigators use both distal (-) and proximal (+) electrodes which can be attached to any two of the V leads, record as V(-) and V(+). Monitoring positions of the electrodes by V(-) and V(+) could provide more information about the tip position. Comparing the QRS amplitudes between V(-) and V(+), when catheter tip enters right ventricle chamber: the case of V(-) > V(+) infers tip toward apex ventricle wall ; conversely, the case of V(-)<V(+) indicates tip directs to outflow tract.

The investigators hypothesis this monitoring will help precisely placement.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Temporary transvenous cardiac pacing

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Bedside Precise Temporary Transvenous Cardiac Pacemaker Placement by Intracavitary Electrocardiogram Monitoring
Actual Study Start Date :
Mar 25, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Non-floating catheter

When using non-floating catheter.

Procedure: Temporary transvenous cardiac pacing
Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.

Floating catheter

When using floating catheter.

Procedure: Temporary transvenous cardiac pacing
Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.

Outcome Measures

Primary Outcome Measures

  1. Pacer leads location [One day.]

    Satisfy location is in the apex of the right ventricle.

  2. Catheter-related complications [One month.]

    Pacing catheter related complications: tip dislocation caused pacemaker malfunction, myocardial injury, perforation, death.

Secondary Outcome Measures

  1. Other complications [One month.]

    Complications not relate to pacing catheter.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with indication of temporary transvenous pacing
Exclusion Criteria:
  • Not applicate to IC-ECG monitoring.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hunan Provincial People's hospital Changsha Hunan China 410000

Sponsors and Collaborators

  • Hunan Provincial People's Hospital

Investigators

  • Study Director: Xiaotong Han, MD, Hunan Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meng Liu, Attending physician, Hunan Provincial People's Hospital
ClinicalTrials.gov Identifier:
NCT04905199
Other Study ID Numbers:
  • 202084
First Posted:
May 27, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021