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Clinical Trials/NCT05480254
NCT05480254
Unknown
Not Applicable

The Effect on Catheter-Related Complıcatıons of Clamping Method the Indwelling Urinary Catheters in ICU Patıents: A Randomızed Controlled Trial

Hulya Kocyigit1 site in 1 country110 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bladder Training by Clamping Before Removal
Sponsor
Hulya Kocyigit
Enrollment
110
Locations
1
Primary Endpoint
Enfectious complications
Last Updated
3 years ago

Overview

Brief Summary

Background: Bladder training through catheter clamping is an important nursing practice. There is no clear information and sufficient evidence for catheter clamping in bladder training before urinary catheter removal in guidelines for clinical practice.

Objective: To evaluate the results of bladder training in ICU patients. Design: Randomized controlled trial. Setting general surgery ıntensıve care. Methods: Patients were randomly assigned either to have their urinary catheter clamped before removal or to have their catheter removed with free drainage.. Patients who will continue to have urinary catheterization for at least 5 days were included in the study.

Results: - Conclusion: -

Detailed Description

Nurses are key professionals in the prevention of complications associated with indwelling urinary catheterization in the hospital setting. In this context, bladder training through catheter clamping is an important nursing practice. Indwelling catheter clamping in bladder training was first proposed by Ross in 1936. There is no clear information and sufficient evidence for catheter clamping in bladder training before urinary catheter removal in national and international guidelines for clinical practice. In a study by Williamson (1982) on this subject, it was reported that intermittent clamping before removal of the indwelling urinary catheter reduces the frequency of urinary retention and shortens the time to return to normal bladder function. However, a systematic review published in Cochrane (2007) on strategies for removal of short-term indwelling urethral catheters in adults found insufficient evidence to suggest that catheter clamping prior to termination of catheterization is effective to induce normal bladder filling. In another systematic review published in Cochrane (2016), there was no significant difference between the patients' subjective perceptions of recatheterization, urinary retention, catheter-related urinary tract infection and urination symptoms in the clamping and free drainage groups. In the limited number of studies on bladder training performed by clamping the indwelling urinary catheter, no evidence for practice could be obtained, and there is no consensus among clinicians yet. Ultimately, more research, better quality methodology, and more diverse study designs are needed until strong evidence is available to remove this uncertainty.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
October 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Hulya Kocyigit
Responsible Party
Sponsor Investigator
Principal Investigator

Hulya Kocyigit

Principal Investigator

Cumhuriyet University

Eligibility Criteria

Inclusion Criteria

  • Glasgow Coma Scale between 13-15 when clamping will be performed.
  • Within the first 12 hours of admission to the intensive care unit,
  • Will continue urinary catheterization for at least 5 days,
  • No diagnosed or recurrent urinary tract infection,
  • Patients who agreed to participate in the study by obtaining their informed consent and who will not leave the study during the study.

Exclusion Criteria

  • Having urinary outflow resistance/difficulty (prostate enlargement, urethral stenosis, etc.),
  • Those who have suprapubic catheters or who will undergo intermittent catheterization,
  • Patients with impaired nerve conduction,
  • Patients taking anticholinergic drug therapy such as tricyclic antidepressants,
  • Patients receiving sympathomimetric drug therapy,
  • Having a neurogenic bladder,
  • Having diabetic cystopathy, Have a previous history of urinary retention or urination dysfunction,

Outcomes

Primary Outcomes

Enfectious complications

Time Frame: 1-5 days

Catheter-Related Infectious Complications Follow-up Form

Secondary Outcomes

  • Other complications(6. days 1-12 hour between)

Study Sites (1)

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