Safety Issues — Innovative Device for Intravenous Administration
Citation(s)
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.
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.
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. Review.
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.
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.
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.
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;(6):CD011070. doi: 10.1002/14651858.CD011070.pub2. Review.
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.
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.
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.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
