Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
146 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-07-31
Study Completion Date
2020-11-30
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Safety Issues
Medical Device
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Patients and clinical staff will not be entirely blind after group allocation due to the nature of the interventions. Despite this, participants will not be directly informed of their group allocation in terms of usual care or intervention, and the nurses in the clinical staff will only be informed about the broad purposes of the research \[41\] - the study of a new double-chamber syringe for intravenous administration and flushing. In contrast, research nurses from the team outside the orthopaedic department will be blinded when rating some of the main outcomes such as phlebitis and infiltration.
Study Groups
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Double-Chamber Syringe
Intravenous administration of drugs and flushing with the Double-Chamber Syringe
Group Type
EXPERIMENTAL
Drug administration and Flushing procedure using Double-Chamber Syringe
Intervention Type
DEVICE
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.
Classical Syringes
Intravenous administration of drugs and flushing with the classical syringe
Group Type
ACTIVE_COMPARATOR
Drug administration and Flushing procedure using Classic Syringe
Intervention Type
DEVICE
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.
Interventions
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Drug administration and Flushing procedure using Double-Chamber Syringe
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.
Intervention Type
DEVICE
Drug administration and Flushing procedure using Classic Syringe
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.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* 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;
* 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.
* 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;
* 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.
Exclusion Criteria
* \- 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;
* 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.
* 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;
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital de Braga
OTHER
Sponsor Role
collaborator
Unidade Local de Saúde de Coimbra, EPE
OTHER
Sponsor Role
collaborator
Hospital Distrital da Figueira da Foz, EPE
UNKNOWN
Sponsor Role
collaborator
Escola Superior de Enfermagem de Coimbra
OTHER
Sponsor Role
lead
Responsible Party
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Pedro Miguel Santos Dinis Parreira
Ph.D, Coordinating Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Pedro Parreira, PhD
Role: PRINCIPAL_INVESTIGATOR
Coordinating Professor
Central Contacts
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Anabela Salgueiro-Oliveira, PhD
Role: CONTACT
+351 239802850 / 239487200 ext. 3302
References
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Marsh 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.
Reference Type
BACKGROUND
Goossens 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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Abolfotouh 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.
Reference Type
BACKGROUND
Braga 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.
Reference Type
BACKGROUND
Ho 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.
Reference Type
BACKGROUND
Park 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.
Reference Type
BACKGROUND
Rickard 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.
Reference Type
BACKGROUND
Martinez 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.
Reference Type
BACKGROUND
Wallis 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.
Reference Type
BACKGROUND
Capdevila 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.
Reference Type
BACKGROUND
Loveday 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.
Reference Type
BACKGROUND
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 (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.
Reference Type
BACKGROUND
Keogh 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.
Reference Type
BACKGROUND
Ferroni 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.
Reference Type
BACKGROUND
Bishop L, Dougherty L, Bodenham A, Mansi J, Crowe P, Kibbler C, Shannon M, Treleaven J. Guidelines on the insertion and management of central venous access devices in adults. Int J Lab Hematol. 2007 Aug;29(4):261-78. doi: 10.1111/j.1751-553X.2007.00931.x.
Reference Type
BACKGROUND
Guiffant G, Durussel JJ, Merckx J, Flaud P, Vigier JP, Mousset P. Flushing of intravascular access devices (IVADs) - efficacy of pulsed and continuous infusions. J Vasc Access. 2012 Jan-Mar;13(1):75-8. doi: 10.5301/JVA.2011.8487.
Reference Type
BACKGROUND
Ngo A, Murphy S. A theory-based intervention to improve nurses' knowledge, self-efficacy, and skills to reduce PICC occlusion. J Infus Nurs. 2005 May-Jun;28(3):173-81. doi: 10.1097/00129804-200505000-00005.
Reference Type
BACKGROUND
Boutron I, Guittet L, Estellat C, Moher D, Hrobjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med. 2007 Feb;4(2):e61. doi: 10.1371/journal.pmed.0040061.
Reference Type
BACKGROUND
Keogh S, Flynn J, Marsh N, Mihala G, Davies K, Rickard C. Varied flushing frequency and volume to prevent peripheral intravenous catheter failure: a pilot, factorial randomised controlled trial in adult medical-surgical hospital patients. Trials. 2016 Jul 26;17(1):348. doi: 10.1186/s13063-016-1470-6.
Reference Type
BACKGROUND
Marsh N, Webster J, Flynn J, Mihala G, Hewer B, Fraser J, Rickard CM. Securement methods for peripheral venous catheters to prevent failure: a randomised controlled pilot trial. J Vasc Access. 2015 May-Jun;16(3):237-44. doi: 10.5301/jva.5000348. Epub 2015 Feb 4.
Reference Type
BACKGROUND
Rickard CM, Webster J, Wallis MC, Marsh N, McGrail MR, French V, Foster L, Gallagher P, Gowardman JR, Zhang L, McClymont A, Whitby M. Routine versus clinically indicated replacement of peripheral intravenous catheters: a randomised controlled equivalence trial. Lancet. 2012 Sep 22;380(9847):1066-74. doi: 10.1016/S0140-6736(12)61082-4.
Reference Type
BACKGROUND
Tuffaha HW, Rickard CM, Webster J, Marsh N, Gordon L, Wallis M, Scuffham PA. Cost-effectiveness analysis of clinically indicated versus routine replacement of peripheral intravenous catheters. Appl Health Econ Health Policy. 2014 Feb;12(1):51-8. doi: 10.1007/s40258-013-0077-2.
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BACKGROUND
Dillon MF, Curran J, Martos R, Walsh C, Walsh J, Al-Azawi D, Lee CS, O'Shea D. Factors that affect longevity of intravenous cannulas: a prospective study. QJM. 2008 Sep;101(9):731-5. doi: 10.1093/qjmed/hcn078. Epub 2008 Jul 11.
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BACKGROUND
Dunda SE, Demir E, Mefful OJ, Grieb G, Bozkurt A, Pallua N. Management, clinical outcomes, and complications of acute cannula-related peripheral vein phlebitis of the upper extremity: A retrospective study. Phlebology. 2015 Jul;30(6):381-8. doi: 10.1177/0268355514537254. Epub 2014 May 20.
Reference Type
BACKGROUND
Parreira P, Sousa LB, Marques IA, Santos-Costa P, Braga LM, Cruz A, Salgueiro-Oliveira A. Double-chamber syringe versus classic syringes for peripheral intravenous drug administration and catheter flushing: a study protocol for a randomised controlled trial. Trials. 2020 Jan 14;21(1):78. doi: 10.1186/s13063-019-3887-1.
Reference Type
DERIVED
Other Identifiers
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SeringaDuo
Identifier Type: -
Identifier Source: org_study_id
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