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COMPARISON OF LOCAL INFECTION, DWELL TIME AND PAIN IN PERIPHERAL VENOUS CANNULATION PASSED BY EXPERTS VERSUS GENERAL INSERTERS IN A TERTIARY CARE HOSPITAL

Protocol summary

Study aim
The objective of this study is to compare the incidence of local infection, dwell time and pain associated with peripheral venous cannulation (PVC) when performed by experts versus general inserters in a tertiary care hospital
Design
It was a single-center study conducted at a tertiary care hospital in Punjab, Pakistan over period of 6 months from April, 2023 to October, 2023. The sample size was 350 individuals. individuals were randomly divided into two groups i.e. expert group and general inserter group using a computer-generated table of random numbers. The study was double blind
Settings and conduct
The study was carried out at Departments of Medicine, Anesthesiology and Intensive Care, Pak Emirates Military Hospital Rwp from Apr 2023-Sept 2023. Participants, care providers, and investigators were blinded
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients above the age of 18 years admitted to the medical wards requiring peripheral intravenous access for more than 24 hours were included. Exclusion Criteria: Patients with peripheral vascular disease, infection of the upper limbs hindering or contraindicating peripheral venous line insertion, patients with a current bloodstream infection, and patients unwilling for the study
Intervention groups
The Expert Group (intervention group)consisted of 175 patients who received intravenous cannulation by experts i.e. trained medical professionals. The General Inserters (Comparison Group) group consisted of 175 patients who had intravenous cannulation by general inserters
Main outcome variables
Infection, dwell time, phlebitis, extravasation, cannulation failure, and pain were studied

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230925059510N1
Registration date: 2024-02-21, 1402/12/02
Registration timing: retrospective

Last update: 2024-02-21, 1402/12/02
Update count: 0
Registration date
2024-02-21, 1402/12/02
Registrant information
Name
Elleyyeen Avais
Name of organization / entity
Pak Emirates Military Hospital
Country
Pakistan
Phone
+92 51 9273927
Email address
elleyyeen@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-10-03, 1402/07/11
Actual recruitment start date
2023-04-03, 1402/01/14
Actual recruitment end date
2023-10-03, 1402/07/11
Trial completion date
2023-10-03, 1402/07/11
Scientific title
COMPARISON OF LOCAL INFECTION, DWELL TIME AND PAIN IN PERIPHERAL VENOUS CANNULATION PASSED BY EXPERTS VERSUS GENERAL INSERTERS IN A TERTIARY CARE HOSPITAL
Public title
Comparison of cannulas inserted by experts versus general inserters
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients above the age of 18 years admitted to the medical wards requiring peripheral intravenous access for more than 24 hours
Exclusion criteria:
Patients with peripheral vascular disease, infection of the upper limbs hindering or contraindicating peripheral venous line insertion, patients with a current bloodstream infection and patients unwilling to be included in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 400
Actual sample size reached: 350
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization technique was used. Individuals were allotted one of the 2 groups: Group X (Expert Inserter Group) and Group Y (General Inserter Group). The randomization was done using a list generated by online software. A consecutive sampling technique was used to fill the list. Allocation concealment was carried out
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, Care providers, and investigators were blinded by giving unique numbers to participants not pointing toward the identity of either group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Pak Emirates Military Hospital
Street address
Abid Majeed Road
City
Rawalpindi
Postal code
46000
Approval date
2023-04-03, 1402/01/14
Ethics committee reference number
A/28/ER/592/23

Health conditions studied

1

Description of health condition studied
Peripheral venous cannulation associated phelebitis, infection and pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Local infection
Timepoint
Before intervention and at 24, 48, and 72 hours
Method of measurement
Likert Scale

2

Description
Pain
Timepoint
Before intervention and at 24, 48, and 72 hours
Method of measurement
Visual Analogue Scale

3

Description
Dwell Time
Timepoint
Before intervention and at 24, 48, and 72 hours
Method of measurement
By noting time of insertion of cannula and it's removal

Secondary outcomes

1

Description
Multiple Insertion attempt
Timepoint
At 2, 4 and 6 minutes
Method of measurement
Number of attempts were noted while inserting cannula

Intervention groups

1

Description
Group E was handled by Experts. In this group, a peripheral venous cannula of 20G was inserted by experts in any of the upper limbs.
Category
Prevention

2

Description
Intervention group: Group G was handled by General Inserters. In this group, a peripheral venous cannula of 20G was inserted by general inserters in any of the upper limbs.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Pak Emirates Military Hospital
Full name of responsible person
Elleyyeen Avais
Street address
Abid Majeed Road
City
Rawalpindi
Postal code
46000
Phone
+92 316 5110954
Email
elleyyeen@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Elleyyeen Avais
Street address
Abid Majeed Road
City
Rawalpindi
Postal code
46000
Phone
+92 316 5110954
Email
elleyyeen@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pak Emirates Military Hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Elleyyeen Avais
Position
Resident Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 316 5110954
Email
elleyyeen@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Elleyyeen Avais
Position
Registrar Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 316 5110954
Fax
Email
elleyyeen@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Elleyyeen Avais
Position
Registrar Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Abid Majeed Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 316 5110954
Fax
Email
elleyyeen@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Primary Outcomes data will shared.
When the data will become available and for how long
It will be made available after publication of trial for 2 years
To whom data/document is available
To healthcare professionals in Pakistan
Under which criteria data/document could be used
For reviewing purposes only
From where data/document is obtainable
Elleyyeen Avais Resident Medicine Pak Emirates Military Hospital Rawalpindi Pakistan elleyyeen@gmail.com 00923165110954
What processes are involved for a request to access data/document
through email only
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