Clinical trial · Interventional
Ipsilateral Peripheral Intravenous Access Procedures (The iPIVAP Study)
Implementing Ipsilateral Peripheral Intravenous Access Procedures for Routine Scanning in Patients With a History of Surgical Axillary Procedures (The iPIVAP Study)
NCT04570722CI-TRIAL-00065935iPIVAPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot study will examine facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection in a single radiology center.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipsilateral peripheral IV insertion | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm study
- description
- Patients with a history of axillary surgical lymph node procedures (SLNP) presenting for routine radiographic scan will complete baseline measures: bilateral volumetric measurements and self-reported symptoms. Patients will undergo SOC contralateral arm intravenous access attempt. After one failed attempt, ipsilateral intravenous access instead of pedal or neck access will be offered per research protocol. Nursing documentation will reflect the failed venipuncture and categorize a reason for the failed attempt.
- interventionNames
- Other: Ipsilateral peripheral IV insertion
Primary outcomes (1)
- measure
- Identify facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection.
- timeFrame
- Through study completion, an average of 2 years.
- description
- Perceptions of barriers and facilitators by staff will be collected at study end using a qualitative format. Modeled after Melnyk, Fineout-Overholt, and Mays (2008) EBP surveys, open-ended questions will be asked during a focus group to ascertain their perceptions of the impact of the ipsilateral IV access protocol. Staff will be asked what worked well, what barriers did they experience, and what do they recommend for protocol adoption. Constant comparative analysis will be used to categorize themes from their responses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. History of bilateral or unilateral axillary SLNP (sentinel biopsy, lymphadenectomy or dissection) and a previous or current failed contralateral IV attempt or at the discretion of the treating radiologist, a participant who has a history of multiple failed IV placement attempts in the contralateral arm may proceed to IV placement in the ipsilateral arm on the first attempt 2. Scheduled to undergo routine imaging scan with contrast 3. 18 years of age and older 4. Read, reviewed and signed study-specific consent Exclusion Criteria: 1. Active swelling, rash, or injury in bilateral upper extremities 2. Subjects with diabetes, sickle cell disease, and/or peripheral vascular insufficiency as vascular inflammatory processes pose a lymphedema risk
References
Publications (0)
Data not yet available
No reference posted for this study.