Assessment by Ultrasound of the Degree of Venous Dilation, Comparison Between Venodilation by Airglove (TM) Versus Warm-water Immersion (WWI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Name of Measurement: Change in measurement of vein diameter by ultrasound
Study Overview
Brief Summary
To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.
Detailed Description
Failure to cannulate to gain intra-venous access is a common occurrence in patients undergoing chemotherapy, obese patients, intravenous drug users and those with chronic medical problems leading to peripheral venous collapse. Difficulty in gaining IV-access is a serious medical consequence since important life-saving drugs, fluids, blood transfusions, and other medication are usually given via the intravenous route. Most chemotherapy units in the UK rely on venous dilation by immersing the forearm of patients with "difficult to cannulate veins" (DTCV) into a bucket of warm water. There are however, limitations in this method such as controlling water temperature and ensuring proper sterility.
A new device Airglove™ has been developed which directs warm air over the forearm in a polythene sleeve causing venodilation. Preliminary studies in chemotherapy patients suggest that the Airglove™ causes venodilation to the extent of the warm water immersion technique, however further evidence is required with testing on normal healthy volunteers.
Aims and Objectives:
To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The investigator and reviewer were masked to the results
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants > 18 years old
- •Able to give written informed consent
- •Able to understand and complete questionnaire forms independently
Exclusion Criteria
- •Participants < 18 years old
- •Participants with cancer and/or undergoing chemotherapy
- •Participants with difficult to cannulate veins (DTCV)
- •Participants with lymphoedema in either hand
- •Participants with pre-existing Raynaud's disease
- •Participants with Diabetes (Type 1 & 2)
- •Participants with generalised anxiety disorder
- •Participants with diagnosis of hypertension
- •Participants with any cardiovascular disease, previous stroke, episodes of DVT, recent treatment for venous thromboembolism (VTE), recently administered heparin, participants on warfarin or any anticoagulant treatment (including NOACs).
- •Participants not able to give written informed consent
- •Participants not able to comprehend or complete questionnaire forms independently
Arms & Interventions
Airglove arm
Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC.
Intervention: Airglove (TM) (Device)
Warm-water Immersion arm
Participants on the WWI arm were subjected to warming by immersing their forearms into a bucket of warm water at 38.5oC.
Intervention: Warm-water Immersion (Device)
Outcomes
Primary Outcomes
Name of Measurement: Change in measurement of vein diameter by ultrasound
Time Frame: Change from baseline measurements taken within 2 minutes of the intervention
MEASUREMENT TOOL: GE Logic S8 multi-frequency linear-array transducer (L6-15MHz), two-dimension B-mode ultrasound
Secondary Outcomes
No secondary outcomes reported