Difficult Intravenous Accessp-ACCESS-DNCT06719869
Central Venous Catheter vs Midline in Difficulty Access Patient - Pilot Trial
A study testing Midline intravenous catheter and Central Venous Catheter (CVC): in people with Difficult Intravenous Access, run by Region Jönköping County at 1 site in Sweden.
Trial summary
Intravenous access is a necessity for nearly all inpatient medical care. Approximately half of hospitalized patients require a peripheral venous catheter (PVC), either to enable administration of medications intravenously or to repeatedly draw blood samples (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intravenous Access
- What is being tested?
- Midline intravenous catheter and Central Venous Catheter (CVC):
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 13 Jan 2025to 4 Sep 2025
- 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
- • Age 18 and over
- DIVA criterium fulfilled;
- 2 attempts of venous access by 2 clinicians OR
- No visible nor palpable veins OR
- History of difficult venous access
- 4 - 29 days of catheter dwell time anticipated as assessed by referring clinician.
Who cannot join
- Unable to speak Scandinavian
- Cognitive Impairment
- Is to receive hyperosmolar solutions (600 milliosmoles/L or above).
- Is to receive chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Venous Catheter vs Midline in Difficulty Access Patient - A Randomized Controlled Clinical Pilot Trial - Pilot-ACCESS-D
Intravenous access is a necessity for nearly all inpatient medical care. Approximately half of hospitalized patients require a peripheral venous catheter (PVC), either to enable administration of medications intravenously or to repeatedly draw blood samples (1). Establishing a venous access sometimes requires repeated attempts, resulting in multiple needle sticks and prolonged discomfort for patients. In addition, this may lead to a diminished healthcare experience and create a stressful situation for both patients and healthcare personnel (2, 3). Delays in establishing intravenous access can result in setbacks in sample collection and drug administration (4, 5).
Difficult Intravenous Access (DIVA) is a situation that arises "when two or more clinicians fail two or more times to establish a peripheral access using conventional techniques, when a patient lacks visible or palpable veins or the patient has a stated or documented history of DIVA" (6). The prevalence of DIVA varies from 6% to 88% in different studies, primarily due to variations in definition of DIVA. Known risk factors are diabetes, intravenous drug abuse, sex (higher risk for women), chronic illness, obesity, malnutrition, absence of visible or palpable veins (7, 8). Although it is possible to establish a short, standard-length PVC through the help of ultrasound-guidance, this approach has limited scientific support (4, 9-11). In addition, ultrasound-guided PVCs are not health economically justifiable (12).
Read more
There are a handful of alternatives in terms of vascular access devices (VAD) for DIVA patients: Standard short PVC, Midline catheter, Central Venous Catheter (CVC) and Peripherally Inserted Central Catheter (PICC). A Midline is a long (8-12 cm), peripherally inserted venous catheter that is most commonly inserted into the upper arm via the basilic, cephalic or brachial veins, with its tip terminating below the level of the axilla (13). A Central Venous Catheter (CVC) is inserted through one of several veins (subclavian, jugular, or femoral) and terminates in a central vein, typically the superior vena cava, right atrium, or the iliac/inferior vena cava, depending on the insertion site. A PICC is an extended venous catheter inserted peripherally, similar to the Midline, inserted through the veins of the upper arm. However, the PICC terminates centrally, in the superior vena cava. There is some existing evidence supporting that Midline catheters could be safer compared to PICCs in short term (14-16). Today, CVCs are standard of care in many centers, but retrospective data indicate that Midlines could be a feasible option in DIVA patients (17). Furthermore, CVC insertion involves certain risks, such as arterial puncture, hematoma or pneumothorax (18). For DIVA patients in need of venous access for 5 days or more, Midlines are preferred as per the Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) guidelines (13). However, there are no randomized controlled clinical trials comparing Midlines to CVCs in DIVA patients.
Primary aim of study The aim of the study is to test the feasibility of the study protocol before a future large-scale RCT.
Read the detailed description
Methods CONSORT Methods This pilot trial is a randomized, controlled, two-armed study with a sample size of 30 patients. A sample size of 30 is chosen as a convenience sample. The study will be conducted in Ryhov county hospital, in southern Sweden. Hospitalized patients across adult somatic wards with difficult intravenous access, are screened for potential trial recruitment. Patients are identified when staff from the ward contact the vascular access nurse. All inclusion and exclusion criteria are presented in Table 1. Patients identified, screened, and deemed eligible will be approached with study information. The trial is planned in accordance with the CONSORT guidelines for pilot trials (19).
Setting The patient flowchart, depicted in Figure 1, outlines the vascular access procedures at Ryhov County Hospital. This process involves collaboration between a ward nurse and an anesthesia (vascular access) nurse. In case the ward nurse encounters difficulties in establishing venous access, patients are referred to the anesthesia nurse accordingly.
The insertion of catheters occurs in a dedicated post-op area. Clinicians in this setting have the option to choose between establishing a Midline catheter guided by ultrasound or opting for a Central Venous Catheter (CVC), also guided by ultrasound (USG).
Recruitment, Randomization and Blinding Patients are assessed by the vascular access clinician in the Post-op ward. The recruitment process takes place in collaboration with anesthesiologists from the Acute Care and Trauma unit. Written consent and information are obtained by the physician. Subsequently, patients are randomized by the trial clinician using StudyRandomizer (https://www.studyrandomizer.com). Due to the visible nature of the intervention, blinding is not feasible. Trial participants are randomized in a 1:1 ratio using a block size of 6.
Patient identification, screening, and recruitment are outlined in Figure 1. After obtaining written consent, randomization, allocation and insertion of the VAD, patients return to their respective wards.
Intervention, Midline:
Patients in the intervention group receive a 10 cm PowerGlide Pro™ Midline Catheter (Becton Dickinson). Catheters are inserted with ultrasound-guidance by an anesthesiologist using sterile gloves, mask, and large drape. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. All catheters are secured with using a StatLock™ Stabilization device (Becton Dickinson), and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. Choice of insertion site on arm below or above the elbow avoiding catheter across joints and at the clinician's discretion.
Control, Central Venous Catheter (CVC):
Patients in the control group receive a Celsite 320 or 315 (B. Braun) or Pressure Injectable Arrowg+ard Blue Plus+ (Arrow). Catheters are inserted with ultrasound-guidance by an anesthesiologist with maximal sterile precautions (cap, mask, gown, gloves, and large drape) using the Seldinger technique. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. Catheters are secured with monofilament sutures, and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. The choice of insertion site is at the clinician's discretion.
Catheter care Catheters (Midline and CVC) are controlled daily by the ward nurse. Control includes inspection of dressing, puncture site, the catheter itself and tags. The catheter function is assessed and flushed with minimum 20mL saline solution daily and in conjunction to use. For CVCs dressing is replaced every third day or earlier if necessary. Extension tubing, three-way connectors and injection valves are replaced every third day or earlier if necessary. With Midline, StatLock™ Stabilization device is replaced every 7th day or earlier if necessary.
Follow-up Follow-up will be performed in-ward every Monday and every Thursday by a research nurse or research assistant. Follow-up will be performed until the catheter is removed or until 28 days. Patients who are discharged from hospital with their catheter in situ will be followed through telephone interviews and chart reviews of out-patient notes
Ethical considerations Ethical approval from the Swedish Ethical Review Authority is mandatory prior to trial start. The trial will be carried out in accordance with the study protocol under the principles of the Helsinki Declaration. The trial and study protocol will be prospectively registered on www.clinicaltrials.gov.
Regardless of whether a patient participates in the study, the need for venous access remains. Both midline catheters and CVCs are well-established methods for securing venous access, and the study presents no significant disadvantages or ethical concerns associated with their implementation.
Participation in the trial is entirely voluntary and is based on informed and signed consent. Participants have the right to withdraw their consent at any time for any reason, without prejudice to their medical care. Comprehensive oral and written information about the trial will be provided to participants before obtaining their consent and before their inclusion in the study. The research material will be stored in a secure safe where the research team have exclusive access.
Statistical analysis Descriptive statistics are used to outline patients' baseline characteristics. For measurements that follow a normal distribution, group differences will be assessed using Student's t-test. Given the small sample size of 30, Mann-Whitney U test will be used to calculate differences in dwell time and insertion time between groups.
Time plan:
2024 Q1: Protocol construction 2024 Q2: Protocol submitted to Ethics Review Board 2024 Q4: Study start 2025 Q2: Data analysis and manuscript
- Conditions
- Difficult Intravenous Access
- Being tested
- Midline intravenous catheter, Central Venous Catheter (CVC):
- Keywords
- central venous catheterization, midline, difficult intravenous access, randomised controlled trial, pilot trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline intravenous catheterDevice
Patients in the intervention group receive a 10 cm PowerGlide Pro™ Midline Catheter (Becton Dickinson). Catheters are inserted with ultrasound-guidance by an anesthesiologist using sterile gloves, mask, and large drape. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. All catheters are secured with using a StatLock™ Stabilization device (Becton Dickinson), and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. Choice of insertion site on arm below or above the elbow avoiding catheter across joints and at the clinician's discretion.
Central Venous Catheter (CVC):Device
Patients in the control group receive a Celsite 320 or 315 (B. Braun) or Pressure Injectable Arrowg+ard Blue Plus+ (Arrow). Catheters are inserted with ultrasound-guidance by an anesthesiologist with maximal sterile precautions (cap, mask, gown, gloves, and large drape) using the Seldinger technique. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. Catheters are secured with monofilament sutures, and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. The choice of insertion site is at the clinician's discretion
| Study group | Role | What they receive |
|---|---|---|
| Midline catheter | Experimental | Not described Receives: Device: Midline intravenous catheter |
| Central venous catheter | Active comparator | Centrally inserted CVC Receives: Device: Central Venous Catheter (CVC): |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who complete all study procedures accordingly. (Feasibility)
Feasibility is defined as the percentage of participants who complete all study procedures as per protocol. Assesed using screening logs, case report forms, follow-up logs and collected data base.
Measured: From screening to 29 days after enrollment
Percentage of screened patients eligible to participate. (Eligibility)
Eligibility is defined as the percentage of screened patients who meet the inclusion criteria and are eligible to participate in the study. Assessed by screening logs and eligibility criteria checklists.
Measured: At screening.
Percentage of eligible patients who consent to participate. (Recruitment)
Recruitment is defined as the percentage of eligible patients who provide informed consent to participate in the trial. Assessed by consent logs.
Measured: At recruitment to 29 days after recruitment.
Percentage of patients retained in the study. (Retention and attrition)
Retention and attrition is defined as the percentage of patients retained in the study, excluding those lost to follow-up or who withdrew consent. Assessed by follow-up forms.
Measured: From randomization to 29 days after enrollment
Percentage of patients adhering to randomized intervention. (Adherence)
Adherence is defined as the percentage of enrolled patients who receive their randomized intervention as per protocol. Assesed by case report forms.
Measured: From randomization to 29 days after enrollment
Percentage of patients with incomplete data. (Missing data)
Missing data is defined as having less than 10% of enrolled patients' data incomplete. Assesed through case report forms and collected database.
Measured: From randomization to 29 days after enrollment
Percentage of patients requiring multiple venipunctures. (Venipuncture attempts)
Venipuncture attempts are defined as the percentage of enrolled patients requiring 2 or more venipunctures per insertion. Assesed through case report forms.
Measured: At insertion.
Secondary outcomes (3)
Insertion time, minutes
Time for insertion of vascular access device.
Measured: At insertion
Dwell time, days
Dwell time of catheters before removal.
Measured: From randomization to 29 days after enrollment
Number of patients with complications.
Catheter complications (infection, thrombosis and mechanical failure) are measured by objectively through bacterial culture, radiology and clinical expertise as per standard clinical routine. Catheter complications during insertion and reason for removal are also registered during follow-up. Assesed through follow-up logs.
Measured: From randomization to 29 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start13 Jan 2025
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difficult Intravenous AccessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Knut Taxbro, MD, PhD, Principal investigator, Region Jönköping CountyStefanie Seifert, MD, Study director, Region Jönköping County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719869
- Sponsor's protocol ID
- CIV-24-08-048798
- Other IDs
- 2024-05700-01
- Acronym
- p-ACCESS-D
- Status last verified
- Feb 2025
- First submitted
- 25 Nov 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared to other researcher upon a reasonable written request to the study investigators.
Publications
Mellander C, Seifert S, Hammarskjold F, Taxbro K. Central venous versus short midline catheter in difficult intravenous access patients: a randomised clinical pilot trial. BMJ Open. 2026 Feb 12;16(2):e113575. doi: 10.1136/bmjopen-2025-113575.
PubMed 41688107
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Catheter vs Midline in Difficulty Access Patient - A Randomized Controlled Clinical Pilot Trial - Pilot-ACCESS-D
- ClinicalTrials.gov ID
- NCT06719869
- Acronym / sponsor ID
- p-ACCESS-D / CIV-24-08-048798
- Conditions
- Difficult Intravenous Access
- Keywords
- central venous catheterization, midline, difficult intravenous access, randomised controlled trial, pilot trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region Jönköping CountyOther government
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 6 Dec 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.
Intravenous access is a necessity for nearly all inpatient medical care. Approximately half of hospitalized patients require a peripheral venous catheter (PVC), either to enable administration of medications intravenously or to repeatedly draw blood samples (1). Establishing a venous access sometimes requires repeated attempts, resulting in multiple needle sticks and prolonged discomfort for patients. In addition, this may lead to a diminished healthcare experience and create a stressful situation for both patients and healthcare personnel (2, 3). Delays in establishing intravenous access can result in setbacks in sample collection and drug administration (4, 5).
Difficult Intravenous Access (DIVA) is a situation that arises "when two or more clinicians fail two or more times to establish a peripheral access using conventional techniques, when a patient lacks visible or palpable veins or the patient has a stated or documented history of DIVA" (6). The prevalence of DIVA varies from 6% to 88% in different studies, primarily due to variations in definition of DIVA. Known risk factors are diabetes, intravenous drug abuse, sex (higher risk for women), chronic illness, obesity, malnutrition, absence of visible or palpable veins (7, 8). Although it is possible to establish a short, standard-length PVC through the help of ultrasound-guidance, this approach has limited scientific support (4, 9-11). In addition, ultrasound-guided PVCs are not health economically justifiable (12).
There are a handful of alternatives in terms of vascular access devices (VAD) for DIVA patients: Standard short PVC, Midline catheter, Central Venous Catheter (CVC) and Peripherally Inserted Central Catheter (PICC). A Midline is a long (8-12 cm), peripherally inserted venous catheter that is most commonly inserted into the upper arm via the basilic, cephalic or brachial veins, with its tip terminating below the level of the axilla (13). A Central Venous Catheter (CVC) is inserted through one of several veins (subclavian, jugular, or femoral) and terminates in a central vein, typically the superior vena cava, right atrium, or the iliac/inferior vena cava, depending on the insertion site. A PICC is an extended venous catheter inserted peripherally, similar to the Midline, inserted through the veins of the upper arm. However, the PICC terminates centrally, in the superior vena cava. There is some existing evidence supporting that Midline catheters could be safer compared to PICCs in short term (14-16). Today, CVCs are standard of care in many centers, but retrospective data indicate that Midlines could be a feasible option in DIVA patients (17). Furthermore, CVC insertion involves certain risks, such as arterial puncture, hematoma or pneumothorax (18). For DIVA patients in need of venous access for 5 days or more, Midlines are preferred as per the Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) guidelines (13). However, there are no randomized controlled clinical trials comparing Midlines to CVCs in DIVA patients.
Primary aim of study The aim of the study is to test the feasibility of the study protocol before a future large-scale RCT.
Detailed description
Methods CONSORT Methods This pilot trial is a randomized, controlled, two-armed study with a sample size of 30 patients. A sample size of 30 is chosen as a convenience sample. The study will be conducted in Ryhov county hospital, in southern Sweden. Hospitalized patients across adult somatic wards with difficult intravenous access, are screened for potential trial recruitment. Patients are identified when staff from the ward contact the vascular access nurse. All inclusion and exclusion criteria are presented in Table 1. Patients identified, screened, and deemed eligible will be approached with study information. The trial is planned in accordance with the CONSORT guidelines for pilot trials (19).
Setting The patient flowchart, depicted in Figure 1, outlines the vascular access procedures at Ryhov County Hospital. This process involves collaboration between a ward nurse and an anesthesia (vascular access) nurse. In case the ward nurse encounters difficulties in establishing venous access, patients are referred to the anesthesia nurse accordingly.
The insertion of catheters occurs in a dedicated post-op area. Clinicians in this setting have the option to choose between establishing a Midline catheter guided by ultrasound or opting for a Central Venous Catheter (CVC), also guided by ultrasound (USG).
Recruitment, Randomization and Blinding Patients are assessed by the vascular access clinician in the Post-op ward. The recruitment process takes place in collaboration with anesthesiologists from the Acute Care and Trauma unit. Written consent and information are obtained by the physician. Subsequently, patients are randomized by the trial clinician using StudyRandomizer (https://www.studyrandomizer.com). Due to the visible nature of the intervention, blinding is not feasible. Trial participants are randomized in a 1:1 ratio using a block size of 6.
Patient identification, screening, and recruitment are outlined in Figure 1. After obtaining written consent, randomization, allocation and insertion of the VAD, patients return to their respective wards.
Intervention, Midline:
Patients in the intervention group receive a 10 cm PowerGlide Pro™ Midline Catheter (Becton Dickinson). Catheters are inserted with ultrasound-guidance by an anesthesiologist using sterile gloves, mask, and large drape. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. All catheters are secured with using a StatLock™ Stabilization device (Becton Dickinson), and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. Choice of insertion site on arm below or above the elbow avoiding catheter across joints and at the clinician's discretion.
Control, Central Venous Catheter (CVC):
Patients in the control group receive a Celsite 320 or 315 (B. Braun) or Pressure Injectable Arrowg+ard Blue Plus+ (Arrow). Catheters are inserted with ultrasound-guidance by an anesthesiologist with maximal sterile precautions (cap, mask, gown, gloves, and large drape) using the Seldinger technique. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. Catheters are secured with monofilament sutures, and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. The choice of insertion site is at the clinician's discretion.
Catheter care Catheters (Midline and CVC) are controlled daily by the ward nurse. Control includes inspection of dressing, puncture site, the catheter itself and tags. The catheter function is assessed and flushed with minimum 20mL saline solution daily and in conjunction to use. For CVCs dressing is replaced every third day or earlier if necessary. Extension tubing, three-way connectors and injection valves are replaced every third day or earlier if necessary. With Midline, StatLock™ Stabilization device is replaced every 7th day or earlier if necessary.
Follow-up Follow-up will be performed in-ward every Monday and every Thursday by a research nurse or research assistant. Follow-up will be performed until the catheter is removed or until 28 days. Patients who are discharged from hospital with their catheter in situ will be followed through telephone interviews and chart reviews of out-patient notes
Ethical considerations Ethical approval from the Swedish Ethical Review Authority is mandatory prior to trial start. The trial will be carried out in accordance with the study protocol under the principles of the Helsinki Declaration. The trial and study protocol will be prospectively registered on www.clinicaltrials.gov.
Regardless of whether a patient participates in the study, the need for venous access remains. Both midline catheters and CVCs are well-established methods for securing venous access, and the study presents no significant disadvantages or ethical concerns associated with their implementation.
Participation in the trial is entirely voluntary and is based on informed and signed consent. Participants have the right to withdraw their consent at any time for any reason, without prejudice to their medical care. Comprehensive oral and written information about the trial will be provided to participants before obtaining their consent and before their inclusion in the study. The research material will be stored in a secure safe where the research team have exclusive access.
Statistical analysis Descriptive statistics are used to outline patients' baseline characteristics. For measurements that follow a normal distribution, group differences will be assessed using Student's t-test. Given the small sample size of 30, Mann-Whitney U test will be used to calculate differences in dwell time and insertion time between groups.
Time plan:
2024 Q1: Protocol construction 2024 Q2: Protocol submitted to Ethics Review Board 2024 Q4: Study start 2025 Q2: Data analysis and manuscript
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midline catheter | Experimental | Device: Midline intravenous catheter |
| Central venous catheter | Active comparator | Device: Central Venous Catheter (CVC):Centrally inserted CVC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Age 18 and over
Key exclusion criteria (4 listed)
- Unable to speak Scandinavian
- Cognitive Impairment
- Is to receive hyperosmolar solutions (600 milliosmoles/L or above).
- Is to receive chemotherapy
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 intravenous catheterPatients in the intervention group receive a 10 cm PowerGlide Pro™ Midline Catheter (Becton Dickinson). Catheters are inserted with ultrasound-guidance by an anesthesiologist using sterile gloves, mask, and large drape. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. All catheters are secured with using a StatLock™ Stabilization device (Becton Dickinson), and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. Choice of insertion site on arm below or above the elbow avoiding catheter across joints and at the clinician's discretion. | Device | Midline catheter |
| Central Venous Catheter (CVC):Patients in the control group receive a Celsite 320 or 315 (B. Braun) or Pressure Injectable Arrowg+ard Blue Plus+ (Arrow). Catheters are inserted with ultrasound-guidance by an anesthesiologist with maximal sterile precautions (cap, mask, gown, gloves, and large drape) using the Seldinger technique. The insertion site is treated with a solution of 0.5% chlorhexidine (wt/vol) in 70% alcohol (SCHA) and allowed to dry for 1 to 2 minutes prior to insertion. No prophylactic antibiotics are given as per default. Catheters are secured with monofilament sutures, and the site is dressed with a semipermeable dressing (Tegaderm HP; 3M Healthcare, St. Paul, MN). A red paper tag is attached to the catheter, indicating study participation. The choice of insertion site is at the clinician's discretion | Device | Central venous catheter |
Primary outcome
Percentage of participants who complete all study procedures accordingly. (Feasibility)
Time frame: From screening to 29 days after enrollment
Feasibility is defined as the percentage of participants who complete all study procedures as per protocol. Assesed using screening logs, case report forms, follow-up logs and collected data base.
Percentage of screened patients eligible to participate. (Eligibility)
Time frame: At screening.
Eligibility is defined as the percentage of screened patients who meet the inclusion criteria and are eligible to participate in the study. Assessed by screening logs and eligibility criteria checklists.
Percentage of eligible patients who consent to participate. (Recruitment)
Time frame: At recruitment to 29 days after recruitment.
Recruitment is defined as the percentage of eligible patients who provide informed consent to participate in the trial. Assessed by consent logs.
Percentage of patients retained in the study. (Retention and attrition)
Time frame: From randomization to 29 days after enrollment
Retention and attrition is defined as the percentage of patients retained in the study, excluding those lost to follow-up or who withdrew consent. Assessed by follow-up forms.
Percentage of patients adhering to randomized intervention. (Adherence)
Time frame: From randomization to 29 days after enrollment
Adherence is defined as the percentage of enrolled patients who receive their randomized intervention as per protocol. Assesed by case report forms.
Percentage of patients with incomplete data. (Missing data)
Time frame: From randomization to 29 days after enrollment
Missing data is defined as having less than 10% of enrolled patients' data incomplete. Assesed through case report forms and collected database.
Percentage of patients requiring multiple venipunctures. (Venipuncture attempts)
Time frame: At insertion.
Venipuncture attempts are defined as the percentage of enrolled patients requiring 2 or more venipunctures per insertion. Assesed through case report forms.
3 secondary outcomes
Insertion time, minutes
Time frame: At insertion
Dwell time, days
Time frame: From randomization to 29 days after enrollment
Number of patients with complications.
Time frame: From randomization to 29 days after enrollment
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 18 Nov 2025.
- Derived from this study: PubMed 41688107Mellander C, Seifert S, Hammarskjold F, Taxbro K. Central venous versus short midline catheter in difficult intravenous access patients: a randomised clinical pilot trial. BMJ Open. 2026 Feb 12;16(2):e113575. doi: 10.1136/bmjopen-2025-113575.
- Individual participant dataSharing planned: Yes. Data will be shared to other researcher upon a reasonable written request to the study investigators.
Related trials for Difficult Intravenous Access
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Active, not recruitingObservational study
A New Landmark-formula for Cephalic Vein in Children
Venipuncture, Ultrasound
Recruiting
Development and Evaluation of an Algorithm for Vascular Access Management
Peripheral Venous Access
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.
Knut Taxbro, MD, PhD principal investigator
Region Jönköping County
Stefanie Seifert, MD study director
Region Jönköping County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midline intravenous catheter and Central Venous Catheter (CVC): in people with Difficult Intravenous Access, run by Region Jönköping County at 1 site in Sweden.
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 6 inclusion and 4 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 18 Nov 2025. 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 Sweden. 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?
Percentage of participants who complete all study procedures accordingly. (Feasibility) (time frame: From screening to 29 days after enrollment). The study lists 7 primary outcomes in all. 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 NCT06719869, which also lists 1 linked publication.
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 18 Nov 2025.