CancerEAGLENCT05127668
Efficacy of AirGLovE in Difficult Venous Access
A study testing Airglove (TM) and Warm-water Immersion in people with Cancer, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Airglove (TM) and Warm-water Immersion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2019to 16 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants > 18 years old
- Able to give written informed consent
- Able to understand and complete questionnaire forms independently
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Calenonian University
Glasgow, South Lanarkshire, G4 0BA
About this study
Official title: Assessment by Ultrasound of the Degree of Venous Dilation, Comparison Between Venodilation by Airglove (TM) Versus Warm-water Immersion (WWI)
To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.
Read the 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.
- Conditions
- Cancer
- Being tested
- Airglove (TM), Warm-water Immersion
- Keywords
- Cannulation,, Chemotherapy, Difficult venous access, Difficult venepuncture, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Warm-water ImmersionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Airglove arm | Experimental | Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC. Receives: 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. Receives: Device: Warm-water Immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline measurements taken within 2 minutes of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start29 Mar 2019
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Prospective cross-sectional comparative study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127668
- Sponsor's protocol ID
- HLS/PSWAHS/18/168
- Acronym
- EAGLE
- Status last verified
- Nov 2021
- First submitted
- 14 Sep 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment by Ultrasound of the Degree of Venous Dilation, Comparison Between Venodilation by Airglove (TM) Versus Warm-water Immersion (WWI)
- ClinicalTrials.gov ID
- NCT05127668
- Acronym / sponsor ID
- EAGLE / HLS/PSWAHS/18/168
- Conditions
- Cancer
- Keywords
- Cannulation,, Chemotherapy, Difficult venous access, Difficult venepuncture, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective cross-sectional comparative study
| Arm | Type | Receives |
|---|---|---|
| Airglove arm | Experimental | Device: Airglove (TM)Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC. |
| Warm-water Immersion arm | Experimental | Device: Warm-water ImmersionParticipants on the WWI arm were subjected to warming by immersing their forearms into a bucket of warm water at 38.5oC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants > 18 years old
- Able to give written informed consent
- Able to understand and complete questionnaire forms independently
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Airglove arm |
| Warm-water ImmersionThe 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 | Device | Warm-water Immersion arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airglove (TM) and Warm-water Immersion in people with Cancer, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Name of Measurement: Change in measurement of vein diameter by ultrasound (time frame: Change from baseline measurements taken within 2 minutes of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.