Safety IssuesSeringaDUONCT04046770
Innovative Device for Intravenous Administration
A study testing Drug administration and Flushing procedure using Double-Chamber Syringe and Drug administration and Flushing procedure using Classic Syringe in people with Safety Issues and Medical Device, run by Escola Superior de Enfermagem de Coimbra.
Trial summary
The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues, Medical Device
- What is being tested?
- Drug administration and Flushing procedure using Double-Chamber Syringe and Drug administration and Flushing procedure using Classic Syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Nov 2020
- 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
- Patients with 18 years or above, admitted to the orthopaedic department;
- Patients with the ability to fully communicate in Portuguese;
- Patients able to consent;
- Prescribed PIVC for intravenous therapeutic administration;
- PIVC expected to remain for at least 24 hours;
- PIVC inserted at the orthopaedic department;
Show all 9Show fewer
- PIVC size 18 gauge (G) or 20 G;
- Anatomical insertion site in arm, forearm, or back of the hand;
- PIVC secured with a transparent, semi-permeable polyurethane film dressing.
Who cannot join
- - Patients with a known infectious disease;
- Patients with leucocytosis, defined as ≥1200 leukocytes/mm3;
- Patients with anaemia, with haemoglobin levels <13g/dl for men, and <12g/dl for women;
- Patients receiving immunosuppressive treatment within 6 months prior to hospital admission;
- Patients receiving chemotherapy or radiotherapy within 6 months prior to hospital admission;
- Patients with body mass index below 16 kg/m2 or above 39 kg/m2;
Show all 9Show fewer
- Anatomical insertion site in flexion areas (e.g. cubital fossa region) or lower members;
- Skin lesions at the insertion site (e.g. previous infiltration, dermatitis, burns) and skin alterations such as tattoos;
- Peripheral venous alterations resulting from previous hospital admissions.
Trial locations and contacts
No sites are listed yet.
About this study
The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing involves a pre and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, also increasing the need for manipulation of the venous catheter).
A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.
- Conditions
- Safety Issues, Medical Device
- Being tested
- Drug administration and Flushing procedure using Double-Chamber Syringe, Drug administration and Flushing procedure using Classic Syringe
- Keywords
- safety, Effectiveness, Double-chamber syringe, Clinical research, medical devices, nurses, hospital setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug administration and Flushing procedure using Double-Chamber SyringeDevice
The new device will allow the professional to conduct all the procedure (assure the patency/enables the pre-flushing), drugs administration and flushing, using only one device.
Drug administration and Flushing procedure using Classic SyringeDevice
To fully complete the intravenous drug administration with rigor, nurses should flush the catheter pre, post and inbetween drug administration. This implies the use of two or three syringes.
| Study group | Role | What they receive |
|---|---|---|
| Double-Chamber Syringe | Experimental | Intravenous administration of drugs and flushing with the Double-Chamber Syringe Receives: Device: Drug administration and Flushing procedure using Double-Chamber Syringe |
| Classical Syringes | Active comparator | Intravenous administration of drugs and flushing with the classical syringe Receives: Device: Drug administration and Flushing procedure using Classic Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter-related complications: phlebitis
Phlebitis (the irritation or inflammation to the vein wall, associated with warmth, tenderness, erythema or palpable cord) is the most frequent PIVC-related complication, which may have mechanical, chemical, or bacterial causes
Measured: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and 48 hours to 72 hours after catheter removal.
Catheter-related complications: infiltration
Moreover, the extravasation or infiltration of fluids may be responsible for local oedema due to the pervasion of intravenous fluid into the interstitial compartment, causing inflammation of the tissue around the catheter site.
Measured: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Catheter-related complications: occlusion
Occlusion is defined as any circumstance in which the Peripheral Intravenous Catheter (PIVC) does not enable to flush the catheter or infuse fluids/medications and it is a clinical sign of catheter malfunctioning
Measured: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Secondary outcomes (1)
Other catheter-related removal causes not related with the primary outcomes
The secondary outcomes involve other reasons for catheter removal (e.g. accidental dislodgment), maintenance time of the catheter, number of syringes and catheters used during the intravenous treatment, catheterization attempts, nurses' perception about risk and safety, as well as the satisfaction of the participant.
Measured: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and in 48 hours to 72 hours after catheter removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study startJul 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Braga, Unidade Local de Saúde de Coimbra, EPE, Hospital Distrital da Figueira da Foz, EPE
- Responsible party
- Principal investigator, Pedro Miguel Santos Dinis Parreira, Escola Superior de Enfermagem de Coimbra
- Investigators
- Pedro Parreira, PhD, Principal investigator, Coordinating Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046770
- Sponsor's protocol ID
- SeringaDuo
- Acronym
- SeringaDUO
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers.
Publications
Chopra V, Flanders SA, Saint S, Woller SC, O'Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenouse Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med. 2015 Sep 15;163(6 Suppl):S1-40. doi: 10.7326/M15-0744.
PubMed 26369828Abolfotouh MA, Salam M, Bani-Mustafa A, White D, Balkhy HH. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Ther Clin Risk Manag. 2014 Dec 8;10:993-1001. doi: 10.2147/TCRM.S74685. eCollection 2014.
PubMed 25525365Braga LM, Parreira PM, Oliveira ASS, Monico LDSM, Arreguy-Sena C, Henriques MA. Phlebitis and infiltration: vascular trauma associated with the peripheral venous catheter. Rev Lat Am Enfermagem. 2018;26:e3002. doi: 10.1590/1518-8345.2377.3002. Epub 2018 May 17.
PubMed 29791668Ho KH, Cheung DS. Guidelines on timing in replacing peripheral intravenous catheters. J Clin Nurs. 2012 Jun;21(11-12):1499-506. doi: 10.1111/j.1365-2702.2011.03974.x. Epub 2012 Feb 17.
PubMed 22340078Park SM, Jeong IS, Kim KL, Park KJ, Jung MJ, Jun SS. The Effect of Intravenous Infiltration Management Program for Hospitalized Children. J Pediatr Nurs. 2016 Mar-Apr;31(2):172-8. doi: 10.1016/j.pedn.2015.10.013. Epub 2015 Nov 19.
PubMed 26608556Rickard CM, McCann D, Munnings J, McGrail MR. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: a randomised controlled trial. BMC Med. 2010 Sep 10;8:53. doi: 10.1186/1741-7015-8-53.
PubMed 20831782Martinez JA, Piazuelo M, Almela M, Blecua P, Gallardo R, Rodriguez S, Escalante Z, Robau M, Trilla A. Evaluation of add-on devices for the prevention of phlebitis and other complications associated with the use of peripheral catheters in hospitalised adults: a randomised controlled study. J Hosp Infect. 2009 Oct;73(2):135-42. doi: 10.1016/j.jhin.2009.06.031. Epub 2009 Aug 27.
PubMed 19712998Wallis MC, McGrail M, Webster J, Marsh N, Gowardman J, Playford EG, Rickard CM. Risk factors for peripheral intravenous catheter failure: a multivariate analysis of data from a randomized controlled trial. Infect Control Hosp Epidemiol. 2014 Jan;35(1):63-8. doi: 10.1086/674398. Epub 2013 Dec 2.
PubMed 24334800Capdevila JA, Guembe M, Barberan J, de Alarcon A, Bouza E, Farinas MC, Galvez J, Goenaga MA, Gutierrez F, Kestler M, Llinares P, Miro JM, Montejo M, Munoz P, Rodriguez-Creixems M, Sousa D, Cuenca J, Mestres CA; on behalf the SEICAV, SEMI, SEQ and SECTCV Societies. 2016 Expert consensus document on prevention, diagnosis and treatment of short-term peripheral venous catheter-related infections in adult. Rev Esp Quimioter. 2016 Aug;29(4):230-8. Epub 2016 Aug 28.
PubMed 27580009Loveday HP, Wilson JA, Pratt RJ, Golsorkhi M, Tingle A, Bak A, Browne J, Prieto J, Wilcox M, UK Department of Health. epic3: national evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect. 2014 Jan;86 Suppl 1:S1-70. doi: 10.1016/S0195-6701(13)60012-2.
PubMed 24330862O'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 (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. No abstract available.
PubMed 21460264Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters to prevent complications. Cochrane Database Syst Rev. 2015 Jun 12;2015(6):CD011070. doi: 10.1002/14651858.CD011070.pub2.
PubMed 26068958Goossens GA. Flushing and Locking of Venous Catheters: Available Evidence and Evidence Deficit. Nurs Res Pract. 2015;2015:985686. doi: 10.1155/2015/985686. Epub 2015 May 14.
PubMed 26075094Keogh S, Flynn J, Marsh N, Higgins N, Davies K, Rickard CM. Nursing and midwifery practice for maintenance of vascular access device patency. A cross-sectional survey. Int J Nurs Stud. 2015 Nov;52(11):1678-85. doi: 10.1016/j.ijnurstu.2015.07.001. Epub 2015 Jul 11.
PubMed 26206327Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.
PubMed 25404862
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Device for Intravenous Administration
- ClinicalTrials.gov ID
- NCT04046770
- Acronym / sponsor ID
- SeringaDUO / SeringaDuo
- Conditions
- Safety Issues, Medical Device
- Keywords
- safety, Effectiveness, Double-chamber syringe, Clinical research, medical devices, nurses, hospital setting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- Collaborators
- Hospital de Braga, Unidade Local de Saúde de Coimbra, EPE, Hospital Distrital da Figueira da Foz, EPE
- Study start
- Jul 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 6 Aug 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 prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing involves a pre and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, also increasing the need for manipulation of the venous catheter).
A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.
| Arm | Type | Receives |
|---|---|---|
| Double-Chamber Syringe | Experimental | Device: Drug administration and Flushing procedure using Double-Chamber SyringeIntravenous administration of drugs and flushing with the Double-Chamber Syringe |
| Classical Syringes | Active comparator | Device: Drug administration and Flushing procedure using Classic SyringeIntravenous administration of drugs and flushing with the classical syringe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with 18 years or above, admitted to the orthopaedic department;
- Patients with the ability to fully communicate in Portuguese;
- Patients able to consent;
- Prescribed PIVC for intravenous therapeutic administration;
- PIVC expected to remain for at least 24 hours;
Key exclusion criteria (9 listed)
- - Patients with a known infectious disease;
- Patients with leucocytosis, defined as ≥1200 leukocytes/mm3;
- Patients with anaemia, with haemoglobin levels <13g/dl for men, and <12g/dl for women;
- Patients receiving immunosuppressive treatment within 6 months prior to hospital admission;
- Patients receiving chemotherapy or radiotherapy within 6 months prior to hospital admission;
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 |
|---|---|---|
| Drug administration and Flushing procedure using Double-Chamber SyringeThe new device will allow the professional to conduct all the procedure (assure the patency/enables the pre-flushing), drugs administration and flushing, using only one device. | Device | Double-Chamber Syringe |
| Drug administration and Flushing procedure using Classic SyringeTo fully complete the intravenous drug administration with rigor, nurses should flush the catheter pre, post and inbetween drug administration. This implies the use of two or three syringes. | Device | Classical Syringes |
Primary outcome
Catheter-related complications: phlebitis
Time frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and 48 hours to 72 hours after catheter removal.
Phlebitis (the irritation or inflammation to the vein wall, associated with warmth, tenderness, erythema or palpable cord) is the most frequent PIVC-related complication, which may have mechanical, chemical, or bacterial causes
Catheter-related complications: infiltration
Time frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Moreover, the extravasation or infiltration of fluids may be responsible for local oedema due to the pervasion of intravenous fluid into the interstitial compartment, causing inflammation of the tissue around the catheter site.
Catheter-related complications: occlusion
Time frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months).
Occlusion is defined as any circumstance in which the Peripheral Intravenous Catheter (PIVC) does not enable to flush the catheter or infuse fluids/medications and it is a clinical sign of catheter malfunctioning
1 secondary outcome
Other catheter-related removal causes not related with the primary outcomes
Time frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and in 48 hours to 72 hours after catheter removal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 26369828Chopra V, Flanders SA, Saint S, Woller SC, O'Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenouse Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med. 2015 Sep 15;163(6 Suppl):S1-40. doi: 10.7326/M15-0744.
- Background: PubMed 25525365Abolfotouh MA, Salam M, Bani-Mustafa A, White D, Balkhy HH. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Ther Clin Risk Manag. 2014 Dec 8;10:993-1001. doi: 10.2147/TCRM.S74685. eCollection 2014.
- Background: PubMed 29791668Braga LM, Parreira PM, Oliveira ASS, Monico LDSM, Arreguy-Sena C, Henriques MA. Phlebitis and infiltration: vascular trauma associated with the peripheral venous catheter. Rev Lat Am Enfermagem. 2018;26:e3002. doi: 10.1590/1518-8345.2377.3002. Epub 2018 May 17.
- Background: PubMed 22340078Ho KH, Cheung DS. Guidelines on timing in replacing peripheral intravenous catheters. J Clin Nurs. 2012 Jun;21(11-12):1499-506. doi: 10.1111/j.1365-2702.2011.03974.x. Epub 2012 Feb 17.
- Background: PubMed 26608556Park SM, Jeong IS, Kim KL, Park KJ, Jung MJ, Jun SS. The Effect of Intravenous Infiltration Management Program for Hospitalized Children. J Pediatr Nurs. 2016 Mar-Apr;31(2):172-8. doi: 10.1016/j.pedn.2015.10.013. Epub 2015 Nov 19.
- Background: PubMed 20831782Rickard CM, McCann D, Munnings J, McGrail MR. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: a randomised controlled trial. BMC Med. 2010 Sep 10;8:53. doi: 10.1186/1741-7015-8-53.
- Background: PubMed 19712998Martinez JA, Piazuelo M, Almela M, Blecua P, Gallardo R, Rodriguez S, Escalante Z, Robau M, Trilla A. Evaluation of add-on devices for the prevention of phlebitis and other complications associated with the use of peripheral catheters in hospitalised adults: a randomised controlled study. J Hosp Infect. 2009 Oct;73(2):135-42. doi: 10.1016/j.jhin.2009.06.031. Epub 2009 Aug 27.
- Background: PubMed 24334800Wallis MC, McGrail M, Webster J, Marsh N, Gowardman J, Playford EG, Rickard CM. Risk factors for peripheral intravenous catheter failure: a multivariate analysis of data from a randomized controlled trial. Infect Control Hosp Epidemiol. 2014 Jan;35(1):63-8. doi: 10.1086/674398. Epub 2013 Dec 2.
- Background: PubMed 27580009Capdevila JA, Guembe M, Barberan J, de Alarcon A, Bouza E, Farinas MC, Galvez J, Goenaga MA, Gutierrez F, Kestler M, Llinares P, Miro JM, Montejo M, Munoz P, Rodriguez-Creixems M, Sousa D, Cuenca J, Mestres CA; on behalf the SEICAV, SEMI, SEQ and SECTCV Societies. 2016 Expert consensus document on prevention, diagnosis and treatment of short-term peripheral venous catheter-related infections in adult. Rev Esp Quimioter. 2016 Aug;29(4):230-8. Epub 2016 Aug 28.
- Background: PubMed 24330862Loveday HP, Wilson JA, Pratt RJ, Golsorkhi M, Tingle A, Bak A, Browne J, Prieto J, Wilcox M, UK Department of Health. epic3: national evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect. 2014 Jan;86 Suppl 1:S1-70. doi: 10.1016/S0195-6701(13)60012-2.
- Background: PubMed 21460264O'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 (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. No abstract available.
- Background: PubMed 26068958Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters to prevent complications. Cochrane Database Syst Rev. 2015 Jun 12;2015(6):CD011070. doi: 10.1002/14651858.CD011070.pub2.
- Individual participant dataSharing planned: No. No individual participant data will be shared with 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.
Pedro Parreira, PhD principal investigator
Coordinating Professor
Questions about this trial
What is this clinical trial studying?
A study testing Drug administration and Flushing procedure using Double-Chamber Syringe and Drug administration and Flushing procedure using Classic Syringe in people with Safety Issues and Medical Device, run by Escola Superior de Enfermagem de Coimbra.
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 9 inclusion and 9 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 28 Aug 2019. 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 Pedro Parreira, PhD (+351 239802850 / 239487200 ext. 3302, parreira@esenfc.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter-related complications: phlebitis (time frame: This outcome will be assessed during the patient's hospital stay (through study completion, an average of 9 months) and 48 hours to 72 hours after catheter removal.). The study lists 3 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 NCT04046770, which also lists 26 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 28 Aug 2019.