An interventional study of Estandard peripheral venous catheter care protocol and Efecto del masaje proximal y del golpeteo de la palma al puño. in Phlebitis and Catheter Complications, sponsored by Hospital Universitario San Ignacio. Recruiting at 1 site in Colombia. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Hospital Universitario San Ignacio · Not applicable, Interventional, and Prevention
Phlebitis is a clinical condition that develops as a complication of peripheral venous catheter use. Peripheral venous catheterization is a common clinical procedure performed in hospitalized patients, as it provides vascular access for the administration of medications, blood products, and contrast media for diagnostic imaging studies. The pathophysiology of phlebitis involves inflammation of the vascular intima, leading to luminal narrowing and impaired blood flow. These changes are clinically manifested by local signs of inflammation, including erythema, edema, and pain, which have been objectively assessed using several validated clinical assessment scales.
Peripheral venous catheter insertion is a common clinical procedure performed in a substantial proportion of hospitalized patients. It is estimated that between 58.7% and 86.7% of hospitalized patients require a peripheral venous catheter during their hospital stay, and, ideally, catheter dwell time should not exceed six days. Indications for peripheral venous catheterization are diverse and include hemodynamic monitoring, intravenous administration of fluids and medications, blood transfusions, and the administration of contrast media for diagnostic imaging procedures.
Despite being a routine and relatively simple procedure, complications associated with peripheral venous catheter use continue to represent an important public health concern because they are associated with prolonged hospital stays, delayed patient discharge, and increased healthcare costs. The most common complications include phlebitis, infiltration, ecchymosis, extravasation, and embolism. These complications may occur while the catheter remains in place or even up to 96 hours after catheter removal. Therefore, given the widespread use of peripheral venous catheters and the potentially deleterious consequences of these complications, appropriate catheter management and care are essential to reduce their incidence.
Phlebitis is defined as inflammation of the venous intima and is clinically characterized by local inflammatory signs, including erythema, edema, and pain. Reported incidence rates range from 2% to 80%, depending largely on the control of modifiable risk factors. Three major categories of risk factors have been associated with the development of phlebitis. The first comprises patient-related factors, including age, sex, and pre-existing medical conditions. The second includes chemical factors, primarily related to the dose and osmolarity of intravenously administered medications. The third encompasses mechanical factors, such as catheter size, insertion site, and catheter material.
Several types of phlebitis have been described, each associated with different risk factors. Mechanical phlebitis is related to catheter size and material, inadequate catheter stabilization that facilitates catheter movement and subsequent irritation of the vascular wall, and catheter placement near a joint. Bacterial phlebitis develops as a consequence of poor aseptic technique or prolonged catheter dwell time. Finally, chemical phlebitis is associated with the characteristics of the cannulated vein and the type of infused solution, particularly highly acidic or alkaline solutions.
45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.
This study's planned enrollment of 273 is above the median of 134 across 38 interventional studies indexed under Phlebitis.
Browse Phlebitis studies →Hospital Universitario San Ignacio is the lead sponsor of 25 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
a. Eligible participants will be adults aged 18 years or older who have had a PIVC inserted into an upper extremity within the previous 24 hours and are expected to require peripheral intravenous access for at least 48 hours.
Exclusion Criteria:
a.Patients will be excluded if they have impaired consciousness, critical illness precluding participation in the intervention, physical limitations preventing performance of the prescribed exercises, anatomical or functional abnormalities of the catheterized upper extremity, or if adequate clinical follow-up cannot be ensured.
Participants assigned to the control group will receive the standard peripheral venous catheter care protocol implemented at Hospital Universitario San Ignacio
Other: Estandard peripheral venous catheter care protocol
The intervention will consist of two non-pharmacological components. Following hand hygiene, participants will receive gentle massage using the palmar surface of the fingers over an area located approximately 2-3 cm proximal to the peripheral intravenous catheter insertion site. Each session will last approximately 2-3 minutes and will be performed three times daily for up to four consecutive days or until catheter removal, whichever occurs first.
Behavioral: Efecto del masaje proximal y del golpeteo de la palma al puño.
control group will receive the standard peripheral venous catheter care protocol implemented
Following hand hygiene, participants will receive gentle massage using the palmar surface of the fingers over an area located approximately 2-3 cm proximal to the peripheral intravenous catheter insertion site. Each session will last approximately 2-3 minutes and will be performed three times daily for up to four consecutive days or until catheter removal, whichever occurs first
Incidence of phlebitis during the observation period
To evaluate the effect of proximal massage and palm-to-fist tapping exercises on reducing the risk of peripheral venous catheter-related phlebitis during the first 96 hours after catheter insertion
Time frame: Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
Time to first episode of phlebitis, maximum phlebitis severity during follow-up and evaluate factors associated with the development of phlebitis
Participants assigned to the intervention group will receive standardized instruction from the study investigators and will be encouraged
Time frame: Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
Plan to share: No — Individual participant data that underlie the results reported in articles published from this study, after de-identification (text, tables, figures, and appendices), will be shared with researchers who provide a methodologically sound proposal
Ran from Jun 2025 to primary completion in Dec 2025, 6 months.
Of 21 interventional studies with no phase under Phlebitis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitario San Ignacio