Vascular Access DevicesNCT04692753
Effect of Education of Health Care Workers on the Maintenance of Venous Access Devices
An observational study of Vascular Access Devices, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
In intensive care units (ICU), critically ill patients require various venous access devices for fluid resuscitation, drug therapy, or renal replacement therapy (RRT). These include peripheral intravenous catheters (PIVC), specialized venous ports like central venous catheters (CVCs), and hemodialysis ports. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Access Devices
- What is being tested?
- Training and education
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2020to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to Main ICU of PGIMER during the period of data collection
Who may be able to join
- All patients admitted to Main ICU
Who cannot join
- Patients who refuse to give consent
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, 160012
Dr. Rubina Sharma, MBBS, 08427977607, rubinasharma7777@gmail.com
Dr. Neeru Sahni, MD, 09872646106, neerunalin@yahoo.com
About this study
Official title: Effect of Intensive Training and Education of Health Care Workers on the Maintenance of Venous Access Devices in Critically Ill Patients at a Tertiary Care Academic Hospital
In intensive care units (ICU), critically ill patients require various venous access devices for fluid resuscitation, drug therapy, or renal replacement therapy (RRT). These include peripheral intravenous catheters (PIVC), specialized venous ports like central venous catheters (CVCs), and hemodialysis ports. The investigators plan to do this pre- and post-intervention study to know the effect of intensive training and education of HCW (doctors and nurses) on the condition of venous access devices in critically ill patients.
Read the detailed description
Phase 1, pre-intervention: The first twelve weeks will include 25 random visits to main ICU and point observations of all venous access devices under parameters like condition of dressing, connectors and documentation. This will also include the comparison of incidence of CLABSI in the pre and post intervention phase.
Phase 2, intervention: Next four weeks will be an intervention in the form of intensive training and education of the HCW (doctors and nurses). The intensive training will be in the form of an online presentation in which the investigators would have videos on care and maintenance of venous access devices, and the importance of documentation of days of insertion and change of dressing.
Phase 3, post-intervention: Another twelve weeks, post-intervention, again 25 random visits will be done to collect point observations about the same parameters of venous access devices and documentation as done in phase 1.
Statistical analysis: Each of these point observation parameters (for central or peripheral venous access) will be finally categorized as appropriate/inappropriate as per guidelines for best practice.
The compiled data from pre and post intervention phases would be compared. All the categorical parameters (appropriate/inappropriate) will be compared using chi-square test. All the quantitative parameters (e.g. incidence of CLABSI) will be compared using a paired t-test
- Conditions
- Vascular Access Devices
- Being tested
- Training and education
- Keywords
- intensive care unit, health care workers, central venous catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and educationOther
Training and education of health care workers in the form of online seminars and bed side demonstration of care and maintenance of venous access devices
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | baseline data prior to training and education of health care workers. Intervention: intensive training and education of workers for maintenance of venous access devices. | |
| Post intervention | observation after training and education of health care workers Receives: Other: Training and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the effect of intensive training and education of health care workers on care and maintenance of venous access devices in critically ill patients
the maintenance of venous access devices as evident from multiple point observations regarding condition of site ,dressing, connectors
Measured: Seven months
Secondary outcomes (1)
effect of intensive training and education on incidence of CLABSI during pre and post intervention phase
incidence of central line associated blood stream infection to be compared between pre and post intervention phase
Measured: seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Oct 2020
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubina Sharma, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692753
- Sponsor's protocol ID
- NK/6491/MD/147
- Status last verified
- Jan 2021
- First submitted
- 29 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Training and Education of Health Care Workers on the Maintenance of Venous Access Devices in Critically Ill Patients at a Tertiary Care Academic Hospital
- ClinicalTrials.gov ID
- NCT04692753
- Acronym / sponsor ID
- NK/6491/MD/147
- Conditions
- Vascular Access Devices
- Keywords
- intensive care unit, health care workers, central venous catheters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In intensive care units (ICU), critically ill patients require various venous access devices for fluid resuscitation, drug therapy, or renal replacement therapy (RRT). These include peripheral intravenous catheters (PIVC), specialized venous ports like central venous catheters (CVCs), and hemodialysis ports. The investigators plan to do this pre- and post-intervention study to know the effect of intensive training and education of HCW (doctors and nurses) on the condition of venous access devices in critically ill patients.
Detailed description
Phase 1, pre-intervention: The first twelve weeks will include 25 random visits to main ICU and point observations of all venous access devices under parameters like condition of dressing, connectors and documentation. This will also include the comparison of incidence of CLABSI in the pre and post intervention phase.
Phase 2, intervention: Next four weeks will be an intervention in the form of intensive training and education of the HCW (doctors and nurses). The intensive training will be in the form of an online presentation in which the investigators would have videos on care and maintenance of venous access devices, and the importance of documentation of days of insertion and change of dressing.
Phase 3, post-intervention: Another twelve weeks, post-intervention, again 25 random visits will be done to collect point observations about the same parameters of venous access devices and documentation as done in phase 1.
Statistical analysis: Each of these point observation parameters (for central or peripheral venous access) will be finally categorized as appropriate/inappropriate as per guidelines for best practice.
The compiled data from pre and post intervention phases would be compared. All the categorical parameters (appropriate/inappropriate) will be compared using chi-square test. All the quantitative parameters (e.g. incidence of CLABSI) will be compared using a paired t-test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | – | –baseline data prior to training and education of health care workers. Intervention: intensive training and education of workers for maintenance of venous access devices. |
| Post intervention | – | Other: Training and educationobservation after training and education of health care workers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to Main ICU of PGIMER during the period of data collection
Key inclusion criteria (1 listed)
- All patients admitted to Main ICU
Key exclusion criteria (1 listed)
- Patients who refuse to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training and educationTraining and education of health care workers in the form of online seminars and bed side demonstration of care and maintenance of venous access devices | Other | Post intervention |
Primary outcome
To study the effect of intensive training and education of health care workers on care and maintenance of venous access devices in critically ill patients
Time frame: Seven months
the maintenance of venous access devices as evident from multiple point observations regarding condition of site ,dressing, connectors
1 secondary outcome
effect of intensive training and education on incidence of CLABSI during pre and post intervention phase
Time frame: seven months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Devices, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Rubina Sharma, MBBS (08427977607, rubinasharma7777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the effect of intensive training and education of health care workers on care and maintenance of venous access devices in critically ill patients (time frame: Seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.