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EAGLE: Efficacy of AirGLovE in Difficult Venous Access

Sponsor
Glasgow Caledonian University (Other)
Overall Status
Completed
CT.gov ID
NCT05127668
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
18
Actual Duration (Days)
57.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Airglove (TM)
  • Device: Warm-water Immersion
 N/A

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
Actual Enrollment :
34 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Prospective cross-sectional comparative studyProspective cross-sectional comparative study
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
The investigator and reviewer were masked to the results
Primary Purpose:
Health Services Research
Official Title:
Assessment by Ultrasound of the Degree of Venous Dilation, Comparison Between Venodilation by Airglove (TM) Versus Warm-water Immersion (WWI)
Actual Study Start Date :
Mar 29, 2019
Actual Primary Completion Date :
Apr 16, 2019
Actual Study Completion Date :
Apr 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Airglove arm

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

Device: Airglove (TM)
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.
Experimental: 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.

Device: Warm-water Immersion
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

Outcome Measures

Primary Outcome Measures

  1. Name of Measurement: Change in measurement of vein diameter by ultrasound [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Glasgow Calenonian University Glasgow South Lanarkshire United Kingdom G4 0BA

Sponsors and Collaborators

  • Glasgow Caledonian University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Glasgow Caledonian University
ClinicalTrials.gov Identifier:
NCT05127668
Other Study ID Numbers:
  • HLS/PSWAHS/18/168
First Posted:
Nov 19, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Glasgow Caledonian University
Cannulation,
Chemotherapy
Difficult venous access
Difficult venepuncture
Cancer

Study Results

No Results Posted as of Nov 19, 2021