InflammationNCT03871010
Midline Programme - Vascular Nursing Team
An observational study of Inflammation and Local; Infection, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Integration of the Vascular Nursing Team of the Department of Haematooncology, University Hospital Ostrava for the needs of all clinical departments of the hospital. Assessment of local signs of inflammation in patients of the Department of Haematooncology and other clinical departments of the University Hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Local; Infection
- What is being tested?
- Midline catheter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2017to 30 Apr 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with Midline catheter hospitalized at clinical department of the University Hospital Ostrava, Czech Republic
Who may be able to join
- insertion of Midline catheter by nurses from the Vascular Nursing Team
- age over 18 years
Who cannot join
- inability to insert the Midline catheter
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava-Poruba, Czech Republic, 708 52
About this study
Integration of the Vascular Nursing Team of the Department of Haematooncology, University Hospital Ostrava for the needs of all clinical departments of the hospital. Assessment of local signs of inflammation in patients of the Department of Haematooncology and other clinical departments of the University Hospital Ostrava.
Read the detailed description
The study subjects were indicated by a physician for Midline catheter insertion.
Prior to insertion of the catheter, the study subjects were fully informed and signed the informed consent with participation in the study.
Local signs of inflammation were recorded in the study subjects, together with basic demographic characteristics (age, sex, diagnosis), and complications during catheter insertion, the number of days when the Midline catheter was inserted, number of changes of the dressings, presence of neutropenia in the study subjects and the score of local inflammation according to Madonna.
- Degree 0- no pain or reaction in the surrounding
- Degree 1 - pain only, no reaction in the surrounding
- Degree 2 - pain and reddening
- Degree 3 - pain, reddening, swelling or painful stripe along the vein
- Degree 4 - puss, swelling, reddening and painful stripe along the vein The investigators also observed on which day the first signs of infection appeared.
- Conditions
- Inflammation, Local; Infection
- Being tested
- Midline catheter
- Keywords
- Midline catheter, Vascular nursing team
- Medical subject headings
- Inflammation, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline catheterDevice
Midline catheter is used for administration of intravenous therapy, and is inserted in a larger vein.
| Study group | Role | What they receive |
|---|---|---|
| Neutropenia patients, Dept. of Haematooncology | Patients with neutropenia from the Department of Haematooncology were included in this group. Receives: Device: Midline catheter | |
| No neutropenia patients, Dept. of Haematooncology | Patients without neutropenia from the Department of Haematooncology were included in this group. Receives: Device: Midline catheter | |
| No neutropenia patients, other clinical depts. | Patients with neutropenia from the other clinical departments of the University Hospital Ostrava were included in this group. Receives: Device: Midline catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local signs of infection
Local signs of infection were recorded, using the scoring system according to Madonna - see detailed description.
Measured: 3 days at minimum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Feb 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kateřina Hašová, Mgr., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871010
- Sponsor's protocol ID
- KHO-02-Midline
- Other IDs
- RVO-FNOs/2017
- Status last verified
- Oct 2020
- First submitted
- 10 Mar 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators have decided not to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midline Programme - Vascular Nursing Team
- ClinicalTrials.gov ID
- NCT03871010
- Acronym / sponsor ID
- KHO-02-Midline
- Conditions
- Inflammation, Local; Infection
- Keywords
- Midline catheter, Vascular nursing team
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 12 Mar 2019 (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.
Integration of the Vascular Nursing Team of the Department of Haematooncology, University Hospital Ostrava for the needs of all clinical departments of the hospital. Assessment of local signs of inflammation in patients of the Department of Haematooncology and other clinical departments of the University Hospital Ostrava.
Detailed description
The study subjects were indicated by a physician for Midline catheter insertion.
Prior to insertion of the catheter, the study subjects were fully informed and signed the informed consent with participation in the study.
Local signs of inflammation were recorded in the study subjects, together with basic demographic characteristics (age, sex, diagnosis), and complications during catheter insertion, the number of days when the Midline catheter was inserted, number of changes of the dressings, presence of neutropenia in the study subjects and the score of local inflammation according to Madonna.
- Degree 0- no pain or reaction in the surrounding
- Degree 1 - pain only, no reaction in the surrounding
- Degree 2 - pain and reddening
- Degree 3 - pain, reddening, swelling or painful stripe along the vein
- Degree 4 - puss, swelling, reddening and painful stripe along the vein The investigators also observed on which day the first signs of infection appeared.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutropenia patients, Dept. of Haematooncology | – | Device: Midline catheterPatients with neutropenia from the Department of Haematooncology were included in this group. |
| No neutropenia patients, Dept. of Haematooncology | – | Device: Midline catheterPatients without neutropenia from the Department of Haematooncology were included in this group. |
| No neutropenia patients, other clinical depts. | – | Device: Midline catheterPatients with neutropenia from the other clinical departments of the University Hospital Ostrava were included in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Midline catheter hospitalized at clinical department of the University Hospital Ostrava, Czech Republic
Key inclusion criteria (2 listed)
- insertion of Midline catheter by nurses from the Vascular Nursing Team
- age over 18 years
Key exclusion criteria (1 listed)
- inability to insert the Midline catheter
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 |
|---|---|---|
| Midline catheterMidline catheter is used for administration of intravenous therapy, and is inserted in a larger vein. | Device | Neutropenia patients, Dept. of Haematooncology, No neutropenia patients, Dept. of Haematooncology, No neutropenia patients, other clinical depts. |
Primary outcome
Local signs of infection
Time frame: 3 days at minimum
Local signs of infection were recorded, using the scoring system according to Madonna - see detailed description.
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 6 Oct 2020.
- Individual participant dataSharing planned: No. The investigators have decided not to make individual participant data available to other researchers.
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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.
Kateřina Hašová, Mgr. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Local; Infection, run by University Hospital Ostrava at 1 site in Czechia.
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 2 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: finished, as of the sponsor's last update on 6 Oct 2020. 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 Czechia. 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?
Local signs of infection (time frame: 3 days at minimum). 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 6 Oct 2020.