Trial Outcomes & Findings for Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil (NCT NCT03719287)
NCT ID: NCT03719287
Last Updated: 2024-10-02
Results Overview
Clinical complications are: phlebitis (grade 1-4), Hematoma, Ecchymosis, Skin injury, Local infection. Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site. Prevalence (%) = (Number of audited PIVC sites with at least one clinical or mechanical complication ÷ Number of audited PIVC sites) x 100
COMPLETED
295 participants
From PIVC insertion to the audit, up to 7 days.
2024-10-02
Participant Flow
Participant milestones
| Measure |
Hospital #1
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
|
Hospital #2
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
|
Hospital #3
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
99
|
96
|
|
Overall Study
COMPLETED
|
100
|
99
|
96
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hospital #1
n=100 Participants
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
|
Hospital #2
n=99 Participants
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
|
Hospital #3
n=96 Participants
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
NA Years
STANDARD_DEVIATION NA • n=100 Participants
|
NA Years
STANDARD_DEVIATION NA • n=99 Participants
|
NA Years
STANDARD_DEVIATION NA • n=96 Participants
|
54.88 Years
STANDARD_DEVIATION 16.62 • n=295 Participants
|
|
Sex/Gender, Customized
Female Participants
|
NA participants
n=100 Participants
|
NA participants
n=99 Participants
|
NA participants
n=96 Participants
|
166 participants
n=295 Participants
|
|
Sex/Gender, Customized
Male Participants
|
NA participants
n=100 Participants
|
NA participants
n=99 Participants
|
NA participants
n=96 Participants
|
129 participants
n=295 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
100 Participants
n=100 Participants
|
99 Participants
n=99 Participants
|
96 Participants
n=96 Participants
|
295 Participants
n=295 Participants
|
PRIMARY outcome
Timeframe: From PIVC insertion to the audit, up to 7 days.Clinical complications are: phlebitis (grade 1-4), Hematoma, Ecchymosis, Skin injury, Local infection. Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site. Prevalence (%) = (Number of audited PIVC sites with at least one clinical or mechanical complication ÷ Number of audited PIVC sites) x 100
Outcome measures
| Measure |
Hospital #1
n=100 PIVC sites
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
|
Hospital #2
n=100 PIVC sites
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
|
Hospital #3
n=100 PIVC sites
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals
|
|---|---|---|---|
|
Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications)
|
10 percentage of PIVC sites
Interval 4.9 to 17.6
|
6 percentage of PIVC sites
Interval 2.2 to 12.6
|
7 percentage of PIVC sites
Interval 2.9 to 13.9
|
SECONDARY outcome
Timeframe: From PIVC insertion to the audit, up to 7 days.Clinical complications are: phlebitis (grade 1-4), Hematoma, Ecchymosis, Skin injury, Local infection. Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site. Prevalence (%) = (Number of audited PIVC sites with at least one clinical and one mechanical complication ÷ Number of audited PIVC sites) x 100 PIVC sites with at least one clinical complication and one mechanical complication as well.
Outcome measures
| Measure |
Hospital #1
n=100 PIVC sites
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
|
Hospital #2
n=100 PIVC sites
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
|
Hospital #3
n=100 PIVC sites
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals
|
|---|---|---|---|
|
Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical Complications).
|
0 percentage of PIVC sites
Interval 0.0 to 0.0
|
0 percentage of PIVC sites
Interval 0.0 to 0.0
|
1.0 percentage of PIVC sites
Interval 0.0 to 5.4
|
SECONDARY outcome
Timeframe: From PIVC insertion to the audit, up to 7 days.Specific clinical complications are: phlebitis (grade 1 - 4), Hematoma, Ecchymosis, Skin injury, Local infection. Prevalence (%) = (Number of audited PIVC sites with at least one clinical complication ÷ Number of audited PIVC sites) x 100
Outcome measures
| Measure |
Hospital #1
n=100 PIVC sites
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
|
Hospital #2
n=100 PIVC sites
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
|
Hospital #3
n=100 PIVC sites
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals
|
|---|---|---|---|
|
Percentage of PIVC Sites With at Least One Clinical Complication
|
7.0 percentage of PIVC sites
Interval 2.9 to 13.9
|
5.0 percentage of PIVC sites
Interval 1.6 to 11.3
|
5.0 percentage of PIVC sites
Interval 1.6 to 11.3
|
SECONDARY outcome
Timeframe: From PIVC insertion to the audit, up to 7 days.Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site. Prevalence (%) = (Number of audited PIVC sites with at least one mechanical complication ÷ Number of audited PIVC sites) x 100
Outcome measures
| Measure |
Hospital #1
n=100 PIVC sites
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
|
Hospital #2
n=100 PIVC sites
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
|
Hospital #3
n=100 PIVC sites
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals
|
|---|---|---|---|
|
Percentage of PIVC Sites With at Least One Mechanical Complication
|
3.0 percentage of PIVC sites
Interval 0.6 to 8.5
|
1.0 percentage of PIVC sites
Interval 0.0 to 5.4
|
3.0 percentage of PIVC sites
Interval 0.6 to 8.5
|
SECONDARY outcome
Timeframe: From PIVC insertion to the audit, up to 7 days.Quality Issues are: Unstable PIVC, Blood reflux,Uncontrolled IV infusion rate,Site dressing partially detached, Site dressing totally detached (site exposed to environment), Medical tape added to dressing edges, Unclean dressing, discomfort at insertion site with and without palpation, uncovered tubing access port, lack of visibility at the PIVC site. Prevalence (%) = (Number of audited PIVC sites with at least one related quality issue ÷ Number of audited PIVC sites) x 100
Outcome measures
| Measure |
Hospital #1
n=100 Participants
Patients who meet inclusion criteria in the first of three participating Brazil hospitals
|
Hospital #2
n=99 Participants
Patients who meet inclusion criteria in the second of three participating Brazil hospitals
|
Hospital #3
n=96 Participants
Patients who meet inclusion criteria in the third of the three participating Brazil hospitals
|
|---|---|---|---|
|
Percentage of PIVC Sites With at Least One Related Quality Issue
|
61 percentage of PIVC sites
Interval 50.7 to 70.6
|
91 percentage of PIVC sites
Interval 83.6 to 95.8
|
77 percentage of PIVC sites
Interval 67.5 to 84.8
|
Adverse Events
Hospital #1
Hospital #2
Hospital #3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60