Catheter-Related InfectionsIDEMNCT04155723
Impact of a Task Delegation to ICU Nurses for Midlines' Placement
An observational study of Catheter-Related Infections, run by Groupe Hospitalier de Bretagne Sud at 1 site in France.
Trial summary
The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2019to 1 Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in ICU for more than 48 hours
Who may be able to join
- Adult patients hospitalized in ICU for more than 48 hours
Who cannot join
- Patient under 18 years old
- Patient under legal guardianship
- Absence of health insurance in France
- Refusal of the patient or his next-of-kin
- Patient with a decision of withholding or withdrawing of life sustaining therapy
- Patient with a subcutaneous central venous port
- Impossibility of infusion on the upper limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Task Delegation to ICU Nurses for Midlines' Placement on the Duration of Exposure to Central Venous Catheters
The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days. These features make it a good alternative to central venous and conventional peripheral venous catheters.
Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters. The aim of the study is to increase the use of Midlines in the unit to reduce the exposure to central venous catheters and their complications, such as infections or thrombosis.
The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines'use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis.
Read the detailed description
The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Although central venous catheters (CVC) are often mandatory in ICU, the risk of catheter-related infections should lead to consider the insertion of peripheral venous catheters. However in ICU patients, presence of edema or poor venous condition may not allow placement of peripheral venous catheter.
Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days (according to manufacturer recommendations). These features make it a good alternative to central venous and conventional peripheral venous catheters. They are placed at the bedside, peripherally into the cephalic or basilic vein, with the tip reaching the axillary vein.
Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. Studies have shown the feasibility and the safety of delegating to nurses placement of CVC and Midlines. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters.
Midlines' implementation has been associated with a decrease in the use of CVC and catheter-related infections. To our knowledge, no study investigated the placement of Midlines by nurses in the ICU.
The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines' use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis. Complications related to Midlines' placement would also be recorded.
- Conditions
- Catheter-Related Infections
- Keywords
- Midlines
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 group | During phase 1, Midlines are inserted only by doctors. | |
| Phase 2 group | During Phase 2, Midlines are preferentially inserted by ICU nurses, and if needed, by doctors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of exposure to central venous catheter
Duration of exposure to central venous catheter (catheter-days per patient-day)
Measured: ICU discharge (usually seven days)
Secondary outcomes (11)
Duration of exposure to peripheral venous catheter
Duration of exposure to peripheral venous catheter (catheter-days per patient-day)
Measured: ICU discharge (usually seven days)
Duration of exposure to Midline
Duration of exposure to Midline (catheter-days per patient-day)
Measured: ICU discharge (usually seven days)
Number of catheter-related infections
Number of catheter-related infections (number of events per 1000 catheter days)
Measured: ICU discharge (usually seven days)
Number of catheter-related infections
Number of catheter-related infections (number of events per 1000 catheter days)
Measured: Hospital discharge (usually two weeks)
Number of catheter-related thrombosis
Number of catheter-related thrombosis (number of events per 1000 catheter days)
Measured: ICU discharge (usually seven days)
Number of catheter-related thrombosis
Number of catheter-related thrombosis (number of events per 1000 catheter days)
Measured: Hospital discharge (usually two weeks)
Number of pneumothorax and arterial punctures
Number of pneumothorax and arterial punctures (for each catheter inserted, percentage)
Measured: ICU discharge (usually seven days)
Number of patients discharged from the ICU with a central venous catheter
Number of patients discharged from the ICU with a central venous catheter (percentage)
Measured: ICU discharge (usually seven days)
Description of the events associated with Midlines' insertion : Number of punctures
Number of punctures (per Midline inserted)
Measured: ICU discharge (usually seven days)
Description of the events associated with Midlines' insertion : Duration of the procedure
Duration of the procedure (in minutes)
Measured: ICU discharge (usually seven days)
Description of the events associated with Midlines' insertion : Failure rate
Failure rate (percentage)
Measured: ICU discharge (usually seven days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Nov 2019
- Primary completion31 Dec 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Catheter-Related InfectionsStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de Bretagne Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Bouju, Groupe Hospitalier de Bretagne Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155723
- Sponsor's protocol ID
- GHBretagneSud
- Acronym
- IDEM
- Status last verified
- Jul 2023
- First submitted
- 25 Oct 2019
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PubMed 21511081Pathak R, Patel A, Enuh H, Adekunle O, Shrisgantharajah V, Diaz K. The Incidence of Central Line-Associated Bacteremia After the Introduction of Midline Catheters in a Ventilator Unit Population. Infect Dis Clin Pract (Baltim Md). 2015 May;23(3):131-134. doi: 10.1097/IPC.0000000000000237.
PubMed 25972725Pathak R, Gangina S, Jairam F, Hinton K. A vascular access and midlines program can decrease hospital-acquired central line-associated bloodstream infections and cost to a community-based hospital. Ther Clin Risk Manag. 2018 Aug 21;14:1453-1456. doi: 10.2147/TCRM.S171748. eCollection 2018.
PubMed 30174427Xu T, Kingsley L, DiNucci S, Messer G, Jeong JH, Morgan B, Shutt K, Yassin MH. Safety and utilization of peripherally inserted central catheters versus midline catheters at a large academic medical center. Am J Infect Control. 2016 Dec 1;44(12):1458-1461. doi: 10.1016/j.ajic.2016.09.010.
PubMed 27908432Shokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.
PubMed 23141920Alexandrou E, Spencer TR, Frost SA, Mifflin N, Davidson PM, Hillman KM. Central venous catheter placement by advanced practice nurses demonstrates low procedural complication and infection rates--a report from 13 years of service*. Crit Care Med. 2014 Mar;42(3):536-43. doi: 10.1097/CCM.0b013e3182a667f0.
PubMed 24145843
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Task Delegation to ICU Nurses for Midlines' Placement on the Duration of Exposure to Central Venous Catheters
- ClinicalTrials.gov ID
- NCT04155723
- Acronym / sponsor ID
- IDEM / GHBretagneSud
- Conditions
- Catheter-Related Infections
- Keywords
- Midlines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Groupe Hospitalier de Bretagne SudUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Nov 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.
The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days. These features make it a good alternative to central venous and conventional peripheral venous catheters.
Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters. The aim of the study is to increase the use of Midlines in the unit to reduce the exposure to central venous catheters and their complications, such as infections or thrombosis.
The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines'use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis.
Detailed description
The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Although central venous catheters (CVC) are often mandatory in ICU, the risk of catheter-related infections should lead to consider the insertion of peripheral venous catheters. However in ICU patients, presence of edema or poor venous condition may not allow placement of peripheral venous catheter.
Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days (according to manufacturer recommendations). These features make it a good alternative to central venous and conventional peripheral venous catheters. They are placed at the bedside, peripherally into the cephalic or basilic vein, with the tip reaching the axillary vein.
Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. Studies have shown the feasibility and the safety of delegating to nurses placement of CVC and Midlines. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters.
Midlines' implementation has been associated with a decrease in the use of CVC and catheter-related infections. To our knowledge, no study investigated the placement of Midlines by nurses in the ICU.
The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines' use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis. Complications related to Midlines' placement would also be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 group | – | –During phase 1, Midlines are inserted only by doctors. |
| Phase 2 group | – | –During Phase 2, Midlines are preferentially inserted by ICU nurses, and if needed, by doctors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in ICU for more than 48 hours
Key inclusion criteria (1 listed)
- Adult patients hospitalized in ICU for more than 48 hours
Key exclusion criteria (7 listed)
- Patient under 18 years old
- Patient under legal guardianship
- Absence of health insurance in France
- Refusal of the patient or his next-of-kin
- Patient with a decision of withholding or withdrawing of life sustaining therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of exposure to central venous catheter
Time frame: ICU discharge (usually seven days)
Duration of exposure to central venous catheter (catheter-days per patient-day)
11 secondary outcomes
Duration of exposure to peripheral venous catheter
Time frame: ICU discharge (usually seven days)
Duration of exposure to Midline
Time frame: ICU discharge (usually seven days)
Number of catheter-related infections
Time frame: ICU discharge (usually seven days)
Number of catheter-related infections
Time frame: Hospital discharge (usually two weeks)
Number of catheter-related thrombosis
Time frame: ICU discharge (usually seven days)
Number of catheter-related thrombosis
Time frame: Hospital discharge (usually two weeks)
Number of pneumothorax and arterial punctures
Time frame: ICU discharge (usually seven days)
Number of patients discharged from the ICU with a central venous catheter
Time frame: ICU discharge (usually seven days)
Description of the events associated with Midlines' insertion : Number of punctures
Time frame: ICU discharge (usually seven days)
Description of the events associated with Midlines' insertion : Duration of the procedure
Time frame: ICU discharge (usually seven days)
Description of the events associated with Midlines' insertion : Failure rate
Time frame: ICU discharge (usually seven days)
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 12 Jul 2023.
- Background: PubMed 21511081O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
- Background: PubMed 25972725Pathak R, Patel A, Enuh H, Adekunle O, Shrisgantharajah V, Diaz K. The Incidence of Central Line-Associated Bacteremia After the Introduction of Midline Catheters in a Ventilator Unit Population. Infect Dis Clin Pract (Baltim Md). 2015 May;23(3):131-134. doi: 10.1097/IPC.0000000000000237.
- Background: PubMed 30174427Pathak R, Gangina S, Jairam F, Hinton K. A vascular access and midlines program can decrease hospital-acquired central line-associated bloodstream infections and cost to a community-based hospital. Ther Clin Risk Manag. 2018 Aug 21;14:1453-1456. doi: 10.2147/TCRM.S171748. eCollection 2018.
- Background: PubMed 27908432Xu T, Kingsley L, DiNucci S, Messer G, Jeong JH, Morgan B, Shutt K, Yassin MH. Safety and utilization of peripherally inserted central catheters versus midline catheters at a large academic medical center. Am J Infect Control. 2016 Dec 1;44(12):1458-1461. doi: 10.1016/j.ajic.2016.09.010.
- Background: PubMed 23141920Shokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.
- Background: PubMed 24145843Alexandrou E, Spencer TR, Frost SA, Mifflin N, Davidson PM, Hillman KM. Central venous catheter placement by advanced practice nurses demonstrates low procedural complication and infection rates--a report from 13 years of service*. Crit Care Med. 2014 Mar;42(3):536-43. doi: 10.1097/CCM.0b013e3182a667f0.
- 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?
An observational study of Catheter-Related Infections, run by Groupe Hospitalier de Bretagne Sud at 1 site in France.
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 7 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 12 Jul 2023. 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 France. 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?
Duration of exposure to central venous catheter (time frame: ICU discharge (usually seven days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155723, which also lists 6 linked publications.
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 12 Jul 2023.