Patient With PICC Lines, PICC
Conditions
Keywords
PICC line, Pilot study, Sleeve cover
Brief summary
Evidence regarding clinical effectiveness and acceptability of PICC sleeves remain limited. Few randomised controlled trials have evaluated PICC sleeves in routine hospital practice, and there is limited evidence regarding their feasibility, safety and influence on line condition. This pilot randomised controlled trial aims to evaluate the feasibility, safety, and user experience of a protective PICC sleeve among hospitalised patients with PICCs.
Interventions
OTHERNovel PICC Sleeve Cover
The novel PICC sleeve cover would be applied on the intervention group in addition to standard PICC securement practices.
Sponsors
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pilot single-centre, parallel-group randomised controlled trial.
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients receiving PICC placement for various medical conditions
Exclusion criteria
* Patients with known allergies to materials in the PICC sleeve * Patients contraindicated for PICC placement * Patients who are aggressive and/or restless * Patients whose skin condition is unsuitable for CHG gel dressing application (e.g. skin with eczema plaques, bullous pemphigoid) * Patients who have no mental capacity to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Recruitment Rate | 16 months | Number of participants recruited over the recruitment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Adherence | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Percentage of participants who were compliant to wearing the PICC sleeve cover |
| Retention of Study Participants across 3 Time-points | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Number of study participants across 3 time-points (2 days after PICC insertion, 14 days after PICC insertion or upon removal, whichever earlier, and 7 days after discharge from hospital) presented as a percentage of the original number of study participants in each arm |
| Completeness of Data Collected | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Percentage of data collected over the ideal number of data to be collected |
| Number of Adverse Events | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Percentage of participants suffering from adverse events over the total number of participants |
| Patient-Reported Dislodgement Risk | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Mean score of all participants rating their perceived dislodgement risk on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm. |
| Patient-Reported Comfort Level | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Mean score of all participants rating their perceived comfort level on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm. |
| Patient-Reported Visibility Level | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Mean score of all participants rating their perceived visibility level on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm. The visibility level refers to the degree the PICC dressing is exposed to the onlookers and how that may affect their own self-image. |
| Patient-Reported User-friendliness | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Mean score of all participants rating their perceived user-friendliness of the PICC dressing on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm. |
| Patient-Reported Acceptability Outcome | From enrolment to 7 days after discharge or upon removal, whichever earlier. | The mean of the mean scores for patient-reported dislodgement risk, comfort level, visibility level and user-friendliness. |
| Staff-Reported Dislodgement Risk | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Mean score of all participants rating their patients' perceived dislodgement risk on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm. |
| Staff-Reported Comfort Level | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Mean score of all participants rating their patients' perceived comfort level on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm. |
| Staff-Reported Visibility Level | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Mean score of all participants rating their patient's perceived visibility level on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm. The visibility level refers to the degree the PICC dressing is exposed to the onlookers and how that may affect their own self-image. |
| Staff-Reported User-friendliness | From enrolment to 7 days after discharge or upon removal, whichever earlier. | Mean score of all participants rating their patient's perceived user-friendliness of the PICC dressing on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm. |
| Staff-Reported Acceptability Outcome | From enrolment to 7 days after discharge or upon removal, whichever earlier. | The mean of the mean scores for staff-reported dislodgement risk, comfort level, visibility level and user-friendliness. |
Countries
Singapore
Outcome results
None listed