Efficacy of AirGLovE in Difficult Venous Access

NCT05127668 | Completed

• 1 other identifier: HLS/PSWAHS/18/168
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.

Conditions

Cancer

Keywords

Cannulation,; Chemotherapy; Difficult venous access; Difficult venepuncture; Cancer

Outcome Measures

Primary Outcomes (1)

• Name of Measurement: Change in measurement of vein diameter by ultrasound

  MEASUREMENT TOOL: GE Logic S8 multi-frequency linear-array transducer (L6-15MHz), two-dimension B-mode ultrasound

  Change from baseline measurements taken within 2 minutes of the intervention

Study Arms (2)

Airglove arm

EXPERIMENTAL

Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC.

Device: Airglove (TM)

Warm-water Immersion arm

EXPERIMENTAL

Participants on the WWI arm were subjected to warming by immersing their forearms into a bucket of warm water at 38.5oC.

Device: Warm-water Immersion

Interventions

Airglove (TM) DEVICE

A sterile polythene-balloon was inflated around the forearm using the AirGloveTM to 38.5oC at setting number-3 for 3 minutes, then removed and the degree of venodilation assessed by ultrasound.

Airglove arm

Warm-water Immersion DEVICE

The upper limbs (to the level of mid-humerus) of participants were immersed in a container filled with a mix of cold-and warm tap-water to 38.5oC for 3 minutes in the WWI method. Arms were towel-dried, and the degree of venodilation was assessed by ultrasound

Warm-water Immersion arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants \> 18 years old
• Able to give written informed consent
• Able to understand and complete questionnaire forms independently

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead

Study Sites (1)

Glasgow Calenonian University

Glasgow, South Lanarkshire, G4 0BA, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and reviewer were masked to the results
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cross-sectional comparative study

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 19, 2021
• Study Start: March 29, 2019
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)