UMIN-CTR Clinical Trial

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
Institute	LPS Institute of Cardiology, GSVM, India
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053348