UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046771
Receipt number R000053348
Scientific Title Unguided temporary pacing via Jugular/Subclavian Vein in an Emergency department of a high volume tertiary care hospital of India: its Safety, Efficacy, and Practicability
Date of disclosure of the study information 2022/01/28
Last modified on 2022/01/28 22:27:28

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Basic information

Public title

Unguided temporary pacing via Jugular/Subclavian Vein in an Emergency department of a high volume tertiary care hospital of India: its Safety, Efficacy, and Practicability

Acronym

Unguided temporary pacing via Jugular/Subclavian Vein in an ER of a high volume tertiary care hospital of India: its Safety, Efficacy, and Practicability

Scientific Title

Unguided temporary pacing via Jugular/Subclavian Vein in an Emergency department of a high volume tertiary care hospital of India: its Safety, Efficacy, and Practicability

Scientific Title:Acronym

Unguided temporary pacing via Jugular/Subclavian Vein in an ER of a high volume tertiary care hospital of India: its Safety, Efficacy, and Practicability

Region

Asia(except Japan)


Condition

Condition

Completed

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety, efficacy, and practicability of unguided Temporary pacemaker insertion by cardiology fellows

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Successful Temporary pacing achieved

Key secondary outcomes

Number of attempts taken for Central venous Puncture,
Procedural time,
Complications
Mortality
Position of the pacing lead


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Temporary pacemaker insertion in patients who presented to our emergency room and had any indication for urgent pacing. The procedure was done without any imaging guidance.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who presented to our emergency room and had any indication for urgent pacing.

Key exclusion criteria

Not willing to undergo the procedure.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Najeeb
Middle name Ullah
Last name Sofi

Organization

LPS Institute of Cardiology

Division name

Department of Cardiology

Zip code

208002

Address

D 17, Medical College Campus, GSVM, Swaroop Nagar, Kanpur India 208002

TEL

00917042132737

Email

sofinajeeb@gmail.com


Public contact

Name of contact person

1st name Najeeb
Middle name Ullah
Last name Sofi

Organization

LPS Institute of Cardiology

Division name

Department of Cardiology

Zip code

208002

Address

D 17, Medical College Campus, GSVM, Swaroop Nagar, Kanpur India 208002

TEL

0091-7042132737

Homepage URL


Email

sofinajeeb@gmail.com


Sponsor or person

Institute

LPS Institute of Cardiology, GSVM, India

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology, LPS Institute of Cardiology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

LPS institute of Cardiology

Address

GT Road, Swaroop Nagar, Kanpur, UP, India

Tel

0091-7042132737

Email

sofinajeeb@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

LPS Institute of Cardiology (India)


Other administrative information

Date of disclosure of the study information

2022 Year 01 Month 28 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

1093

Results

The mean procedure time was 11.5 min.
The mean number of attempts taken for achieving venous accesses was 1.54
The procedure was successful in all but one patient who had stenosis of the Brachiocephalic vein due to previous pacemaker leads.

Results date posted

2022 Year 01 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Of 1093 patients 687 (62.85%) were male and 406 (37.15%) were female. The underlying cause for Temporary pacing was Myocardial infarction in 503 (46.02%), Degenerative block/bradycardia in 448 (40.98%), Drug-induced bradycardia 118 (10.80%), and EOL/permanent pacemaker failure in 24 (2.20%) patients

Participant flow


Adverse events


Local hematoma developed in 37(3.38%) patients.
An arterial puncture while attempting IJV/Subclavian vein cannulation occurred in 25 (2.29%) patients.
Pneumothoraxes developed in 12 (1.1%) patients
Subcutaneous Emphysema developed in 5 (0.46%) patients.
VT developed during insertion in 9 (0.82%) patients
Pericardial effusion was seen in 21 (1.92%) patients
Vascular perforation due to lead or sheath developed in 1 (0.09%) patient.
No mortality attributable to the procedure happened.

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 01 Month 01 Day

Date of IRB

2020 Year 01 Month 05 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2021 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2021 Year 08 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 01 Month 28 Day

Last modified on

2022 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053348


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name