Ipsilateral Peripheral Intravenous Access Procedures (The iPIVAP Study)

Breast Cancer Clinical Trial

— iPIVAP  

Official title:

Implementing Ipsilateral Peripheral Intravenous Access Procedures for Routine Scanning in Patients With a History of Surgical Axillary Procedures (The iPIVAP Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570722
• Other study ID #: Pro00106186
• Status: Completed
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: January 9, 2023

Study information

• Verified date: April 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This prospective single arm study will be conducted within DUH Department of Radiology CT Imaging. The study team will enroll 50 patients with a history of axillary SLNP presenting for routine radiographic scan to undergo ipsilateral IV insertion. Patients will complete baseline bilateral arm volumetric measurements and self-reported symptom assessments. Patients will be followed every 3 months for 1-year duration for development of lymphedema. Patient acceptance or reluctance to ipsilateral IV access will be categorized at time of screening. Staff uptake on practice change will be assessed through medical record documentation for number, location, and factors affecting IV attempts and their perceptions of practice change and acceptance at the end of one year.

All participants will complete baseline measures: bilateral volumetric measurements and self-reported symptoms. Per DUH policy, participants 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. 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.

Patients with successful ipsilateral intravenous access will be provided a patient education sheet describing signs and symptoms that should be reported to the study team. All participants will be contacted by the study team at twelve week intervals for 12 months after their radiology encounter for completion of symptom assessments. If a subject reports new signs or symptoms of lymphedema during follow-up, a clinic appointment for volumetric measurements and thorough evaluation will occur within 2 weeks; findings will be discussed with their physician. Participants will undergo bilateral volumetric measurements, symptom assessments, and perceptions of the ipsilateral IV access protocol at the end of one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Lymphedema
• Lymphedema of Upper Arm
• Melanoma
• Thoracic Cancer

Intervention

Other:
• Ipsilateral peripheral IV insertion
Patients with successful ipsilateral intravenous access will be provided a patient education sheet describing signs and symptoms that should be reported to the study team. All participants will be contacted by the study team at twelve week intervals for 12 months after their radiology encounter for completion of symptom assessments. If a subject reports new signs or symptoms of lymphedema during follow-up, a clinic appointment for volumetric measurements and thorough evaluation will occur

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify facilitators and barriers that impact staff uptake for implementation of practice change involving ipsilateral IV insertion in patients with axillary lymphadenectomy/dissection.	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	Through study completion, an average of 2 years.
Secondary	Volumetric measurements	Volumetric measurements will be obtained using a tape measure to assess limb girth circumference at five anatomic points. A difference of 2 centimeters or more in arm circumference at a corresponding point between ipsilateral and contralateral arms is considered a common criterion for a diagnosis of lymphedema.(Armer et al 2003)	Baseline and at 12 months post ipsilateral IV insertion
Secondary	Lymphedema symptoms; patient reported outcomes (PRO)	The Lymphedema Breast Cancer Questionnaire (LBCQ) uses 3 items to assess 19 symptoms most commonly associated with lymphedema (Radina et al., 2007). The LBCQ shows an acceptable measure of internal consistency (r=.785) for all 19 items. Test-retest reliability was evaluated using a sample of healthy women without breast cancer or lymphedema (n=35) over a 2-hour test-retest interval. The findings show a high degree of reliability (r =.98).	Baseline, every 3 months after intervention for 12 months
Secondary	Self reported lymphedema changes :patient reported outcomes (PRO)	The Lymphedema Scale uses 2 items for self-reported changes in wrist, elbow, and upper arm sizes. Scale sensitivity ranged from 0.86-0.92 in women with circumferential arm differences >2 cm indicating presence of moderate lymphedema (Norman et al., 2001).	Baseline, every 3 months after intervention for 12 months
Secondary	Study participation acceptance	Potential participants who decline to enroll at time of phone screening: the study team will ask if they would be willing to share a reason for their reluctance. The reasons will be categorized as qualitative responses at the end of study, for example: "I must ask my oncologist permission, I've been told to never allow a procedure in my affected arm".; b) For those enrolled: their perceptions regarding the ipsilateral access will be ascertained at the time of quarterly phone follow-up and at the end of study. Qualitative data will be analysed thematically.; Patient perceptions of acceptance will be assessed in those who opt to or not to participate in thestudy:	Baseline