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Prospective Observational Study of the Power PICC Family of Devices and Accessories
trial testing Peripherally Inserted Central Catheter in Peripherally Inserted Central Catheter in 450 participants. Completed in 5 January 2022.
| Lead sponsor | Becton, Dickinson and Company |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 450 |
| Start date | 18 June 2020 |
| Primary completion | 5 January 2022 |
| Estimated completion | 5 January 2022 |
| Sites | 14 locations across Denmark, Italy, Netherlands, Belgium, Austria, Germany, Switzerland, Spain |
Becton, Dickinson and Company — full company profile →
Eligibility, any sex, with Peripherally Inserted Central Catheter. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging.
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 1.6 | 0.6 – 3.2 |
PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 180-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled. Most patients who died during the study had the device still in place at the time of death and hence were considered as having completed the therapy.
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 81.8 | 77.9 – 85.3 |
Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 0 | 0.0 – 0.8 |
Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 0 | 0.0 – 0.8 |
Incidence of any new occurrence of local infection
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 4.5 | 2.8 – 6.8 |
Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 3.1 | 2.8 – 6.8 |
Incidence of Catheter-related bloodstream infection where Catheter-related bloodstream infection is defined as positive blood culture(s) with a microorganism not related to another source (e.g., UTI) OR positive blood culture(s) with microorganism matching catheter tip culture OR blood cultures from peripheral venous puncture and PICC positive with the same microorganism.
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 1.6 | 0.6 – 3.2 |
Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement.
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 3.8 | 2.2 – 6.6 |
Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel.
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 0.4 | 0.1 – 1.6 |
Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel.
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 0.2 | 0.0 – 1.2 |
Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters.
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 93.9 | 91.3 – 96.0 |
Percent of placement success in single insertion attempt defined as placement success defined as single insertion attempt, proper tip location, and patent catheter
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 90.4 | 87.3 – 93.0 |
Time frame: From PICC insertion though removal or 180 days, whichever comes first. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Subjects |
|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| COVID-19 pneumonia | Infections and infestations | — |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — |
| Catheter bacteraemia | Infections and infestations | — |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| COVID-19 | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Cardiopulmonary failure | Cardiac disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Ileal stenosis | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Cholecystitis acute | Hepatobiliary disorders | — |
| Bacteraemia | Infections and infestations | — |
| Catheter site infection | Infections and infestations | — |
| Septic shock | Infections and infestations | — |
| Subdiaphragmatic abscess | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Electrolyte imbalance | Metabolism and nutrition disorders | — |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | — |
| Reaction | System | All Subjects |
|---|---|---|
| Catheter site erythema | General disorders | — |
| Catheter site infection | Infections and infestations | — |
| Device dislocation | Product Issues | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — |
| Device related thrombosis | General disorders | — |
| Catheter site haemorrhage | General disorders | — |
| Catheter site pain | General disorders | — |
| Catheter bacteraemia | Infections and infestations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Catheter site discharge | General disorders | — |
| Device occlusion | Product Issues | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — |
| Pyrexia | General disorders | — |
| COVID-19 pneumonia | Infections and infestations | — |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Catheter site haematoma | General disorders | — |
| Bacteraemia | Infections and infestations | — |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Catheter site dryness | General disorders | — |
| Catheter site irritation | General disorders | — |
| Catheter site pruritus | General disorders | — |
| Catheter site related reaction | General disorders | — |
| Vessel puncture site injury | General disorders | — |
| COVID-19 | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Cardiopulmonary failure | Cardiac disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Enteritis | Gastrointestinal disorders | — |
| Ileal stenosis | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Catheter site exfoliation | General disorders | — |
| Catheter site granuloma | General disorders | — |
| Catheter site hypersensitivity | General disorders | — |
| Catheter site necrosis | General disorders | — |
| Catheter site edema | General disorders | — |
Most-reported serious reactions: Febrile neutropenia, COVID-19 pneumonia, Lung cancer metastatic, Pulmonary embolism, Catheter bacteraemia, Acute myeloid leukaemia, COVID-19, Pneumonia.
Data from ClinicalTrials.gov NCT04263649 adverse events section.
Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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