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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
67
The novel PICC sleeve cover would be applied on the intervention group in addition to standard PICC securement practices.
Changi General Hospital
Singapore, Singapore
Participant Recruitment Rate
Number of participants recruited over the recruitment period
Time frame: 16 months
Intervention Adherence
Percentage of participants who were compliant to wearing the PICC sleeve cover
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Retention of Study Participants across 3 Time-points
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
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Completeness of Data Collected
Percentage of data collected over the ideal number of data to be collected
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Number of Adverse Events
Percentage of participants suffering from adverse events over the total number of participants
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported Dislodgement Risk
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.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported Comfort Level
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.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported Visibility Level
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.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported User-friendliness
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.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported Acceptability Outcome
The mean of the mean scores for patient-reported dislodgement risk, comfort level, visibility level and user-friendliness.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported Dislodgement Risk
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.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported Comfort Level
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.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported Visibility Level
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.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported User-friendliness
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.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported Acceptability Outcome
The mean of the mean scores for staff-reported dislodgement risk, comfort level, visibility level and user-friendliness.
Time frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
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