Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04692753 |
| Other study ID # |
NK/6491/MD/147 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
April 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Contact |
Dr. Rubina Sharma, MBBS |
| Phone |
08427977607 |
| Email |
rubinasharma7777[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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
