Supportive CareNCT06578494
The Efficacy of Implementing Nurse-performed Ultrasound-guided Peripheral Intravenous Access in Oncology Patients
A study testing Ultrasound in people with Supportive Care, run by Faroese Hospital System.
Trial summary
The purpose of this study is to investigate the clinical efficacy of nurse-performed ultrasound-guided intravenous access in oncology patients on the oncological outpatient unit in the National Hospital of the Faroe Islands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supportive Care
- What is being tested?
- Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2024to 16 Feb 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients admitted to the oncological outpatient unit are eligible for inclusion if they are scheduled for treatment with chemotherapy requiring placement of peripheral intravenous catheter, aged 18 years or older, and reside in the Faroe Islands.
Who cannot join
- Lack of informed consent and mental incapacity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy of Implementing Nurse-performed Ultrasound-guided Peripheral Intravenous Access in Oncology Patients: a Prospective Interventional Clinical Study
The purpose of this study is to investigate the clinical efficacy of nurse-performed ultrasound-guided intravenous access in oncology patients on the oncological outpatient unit in the National Hospital of the Faroe Islands.
Read the detailed description
This project is prospective, interventional, clinical study aligned in four different time stages.
In the first stage, the pre-implementation stage, procedures are as usual, where the patient receives intravenous access via the use of the traditional palpation technique and data will be registered. In the next stage, the training stage, the nurses on the oncological outpatient unit will be trained in the use of the ultrasound-guided technique to place peripheral intravenous catheters and will be supervised by specialists in ultrasound. In the third stage, the implementation stage, the nurses will use the ultrasound technique as a daily routine in their practice. In the fourth stage, the post-implementation stage, the same data registration as in the first stage will be registered (see outcome measures) and the results will be compared in order to see the efficacy before and after implementation of ultrasound guidance. It is estimated a total sample of 100 cannulation procedures with approximately 30 patients needed in the pre-implementation and post-implementation stages.
- Conditions
- Supportive Care
- Being tested
- Ultrasound
- Keywords
- Ultrasonography, Intravenous, Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound-guided peripheral intravenous catheter insertion
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided peripheral intravenous access | Experimental | The patients in the experimental arm will receive ultrasound-guided peripheral intravenous catheter placement, where the dynamic needle tip (DNTP) approach (short-axis) will be used. Receives: Device: Ultrasound |
| Traditional palpation intravenous access technique | Active comparator | The comparator group will receive the traditional palpation intravenous access technique. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
Placement of a functional peripheral intravenous catheter on the first attempt. Defined as retraction of the needle, blood in the plastic catheter, smooth insertion of the plastic catheter and subsequent flush with isotonic saline without signs of extravasal placement.
Measured: The time frame for the outcome measure first attempt succes rate for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Secondary outcomes (5)
Number of skin punctures
Total number of insertion attempts i.e., number of skin punctures needed to successfully insert a peripheral intravenous catheter
Measured: The time frame for the outcome measure number of attempts for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Patient's satisfaction
Arbitrary Likert scale 0-5
Measured: The time frame for the outcome measure patient´s satisfaction for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Patient's experience of pain
Numerical Rating Scale (NRS) scale 0-10
Measured: The time frame for the outcome measure patient´s experience of pain for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Durability
Is the chemotherpy session completed successfully (yes/no). Defined as intravenous chemotherapy successfully infused with only one peripheral intravenous catheter used.
Measured: The time frame for the outcome measure durability for each participant is estimated 4 hours in the pre-implementation stage and 4 hours in the post-implementation stage.
Intravenous complications
Intravenous complications such as e.g., infiltration, extravasation, vessel occlusion etc.
Measured: The time frame for the outcome measure intravenous complications for each participant is estimated 4 hours in the pre-implementation stage and 4 hours in the post-implementation stage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start16 Sep 2024 (estimated)
- Primary completion16 Oct 2025 (estimated)
- Study completion16 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supportive CareStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- This is a before and after study, where the patients pre-implementation stage receive intravenous access via the traditional palpation technique and in the post-implementation stage receive ultrsound-guided intravenous cannulation.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faroese Hospital System
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital of the Faroe Islands, University of the Faroe Islands, University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Peter Juhl-Olsen, MD, PhD, Principal investigator, Aarhus University HospitalAugust Gabriel Wang, MD, DMSc, Principal investigator, University of the Faroe IslandsLisa Maria Anderssen, RN, MHS, Principal investigator, Department of Research, the National Hospital of the Faroe Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578494
- Sponsor's protocol ID
- Ultrasound IV
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data can be shared on a collaborative basis, provided the appropriate approvals
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Implementing Nurse-performed Ultrasound-guided Peripheral Intravenous Access in Oncology Patients: a Prospective Interventional Clinical Study
- ClinicalTrials.gov ID
- NCT06578494
- Acronym / sponsor ID
- Ultrasound IV
- Conditions
- Supportive Care
- Keywords
- Ultrasonography, Intravenous, Oncology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Faroese Hospital SystemUniversity, hospital or other
- Collaborators
- National Hospital of the Faroe Islands, University of the Faroe Islands, University of Aarhus
- Study start
- 16 Sep 2024 (estimated)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 16 Feb 2026 (estimated)
- First posted
- 29 Aug 2024 (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.
The purpose of this study is to investigate the clinical efficacy of nurse-performed ultrasound-guided intravenous access in oncology patients on the oncological outpatient unit in the National Hospital of the Faroe Islands.
Detailed description
This project is prospective, interventional, clinical study aligned in four different time stages.
In the first stage, the pre-implementation stage, procedures are as usual, where the patient receives intravenous access via the use of the traditional palpation technique and data will be registered. In the next stage, the training stage, the nurses on the oncological outpatient unit will be trained in the use of the ultrasound-guided technique to place peripheral intravenous catheters and will be supervised by specialists in ultrasound. In the third stage, the implementation stage, the nurses will use the ultrasound technique as a daily routine in their practice. In the fourth stage, the post-implementation stage, the same data registration as in the first stage will be registered (see outcome measures) and the results will be compared in order to see the efficacy before and after implementation of ultrasound guidance. It is estimated a total sample of 100 cannulation procedures with approximately 30 patients needed in the pre-implementation and post-implementation stages.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a before and after study, where the patients pre-implementation stage receive intravenous access via the traditional palpation technique and in the post-implementation stage receive ultrsound-guided intravenous cannulation.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided peripheral intravenous access | Experimental | Device: UltrasoundThe patients in the experimental arm will receive ultrasound-guided peripheral intravenous catheter placement, where the dynamic needle tip (DNTP) approach (short-axis) will be used. |
| Traditional palpation intravenous access technique | Active comparator | Device: UltrasoundThe comparator group will receive the traditional palpation intravenous access technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cancer patients admitted to the oncological outpatient unit are eligible for inclusion if they are scheduled for treatment with chemotherapy requiring placement of peripheral intravenous catheter, aged 18 years or older, and reside in the Faroe Islands.
Key exclusion criteria (1 listed)
- Lack of informed consent and mental incapacity.
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 |
|---|---|---|
| UltrasoundUltrasound-guided peripheral intravenous catheter insertion | Device | Traditional palpation intravenous access technique, Ultrasound-guided peripheral intravenous access |
Primary outcome
First attempt success rate
Time frame: The time frame for the outcome measure first attempt succes rate for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Placement of a functional peripheral intravenous catheter on the first attempt. Defined as retraction of the needle, blood in the plastic catheter, smooth insertion of the plastic catheter and subsequent flush with isotonic saline without signs of extravasal placement.
5 secondary outcomes
Number of skin punctures
Time frame: The time frame for the outcome measure number of attempts for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Patient's satisfaction
Time frame: The time frame for the outcome measure patient´s satisfaction for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Patient's experience of pain
Time frame: The time frame for the outcome measure patient´s experience of pain for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Durability
Time frame: The time frame for the outcome measure durability for each participant is estimated 4 hours in the pre-implementation stage and 4 hours in the post-implementation stage.
Intravenous complications
Time frame: The time frame for the outcome measure intravenous complications for each participant is estimated 4 hours in the pre-implementation stage and 4 hours in the post-implementation stage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No. IPD data can be shared on a collaborative basis, provided the appropriate approvals
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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.
Peter Juhl-Olsen, MD, PhD principal investigator
Aarhus University Hospital
August Gabriel Wang, MD, DMSc principal investigator
University of the Faroe Islands
Lisa Maria Anderssen, RN, MHS principal investigator
Department of Research, the National Hospital of the Faroe Islands
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Supportive Care, run by Faroese Hospital System.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Maria Anderssen, RN, MHS ((+298) 223820, lisa.anderssen1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt success rate (time frame: The time frame for the outcome measure first attempt succes rate for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.). 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 29 Aug 2024.