Timing of successful removal of urinary catheters in the neurosurgery intensive care unit
| ISRCTN | ISRCTN11643929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11643929 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | VGHKS16-CT7-08 |
| Sponsor | Veterans Affairs Council |
| Funder | Veterans Affairs Council |
- Submission date
- 07/07/2023
- Registration date
- 17/07/2023
- Last edited
- 17/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
An indwelling urinary catheter (IDC) is a catheter which is inserted into the bladder through the urethra and remains in place to drain urine. The duration of indwelling urinary catheterization is a significant risk factor for developing urinary tract infections. Therefore, removing urinary catheters as soon as possible is recommended if there are no longer any indications for their use, such as ongoing urinary retention. This study aims to investigate whether the level of consciousness can be used as an indicator to determine the successful removal of urinary catheters in post-stroke patients admitted to the neurosurgical intensive care unit (NICU).
Who can participate?
Patients in the NICU who have had a stroke and have urinary catheters (UCs)
What does the study involve?
The UC is removed early based on patient conditions. Successful removal of UCs is determined by the absence of the requirement for another UC to be inserted within 48 hours after UC removal.
What are the possible benefits and risks of participating?
The benefits: prevention of urinary tract infections. The risk: unexpected urine retention which will be monitored and remedied right away.
Where is the study run from?
Kaohsiung Veterans General Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
January 2013 to August 2018
Who is funding the study?
Veterans Affairs Council (Taiwan)
Who is the main contact?
Dr Wei-Chuan Chen, coupe055@ms28.hinet.net
Contact information
Scientific
No.386, Da-chung 1st. RD.
Zuoying Dist.
Kaohsiung
813
Taiwan
| Phone | +886 (0)73422121 |
|---|---|
| coupe055@ms28.hinet.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Quasi-experimental design trial |
| Secondary study design | Case series |
| Study type | Participant information sheet |
| Scientific title | Does consciousness level determine the timing of successful removal of urinary catheters in the neurosurgery intensive care unit – implication to nosocomial infection prevention |
| Study objectives | The consciousness level can be an indicator in determining the successful removal of urinary catheters in post-stroke patients at the neurosurgical intensive care unit. |
| Ethics approval(s) |
Approved 03/01/2013, IRB of Kaohsiung Veterans General Hospital (No. 386. Da-chung 1st RD., Zuoying Dist., Kaohsiung, 813, Taiwan; +886 (0)73422121; info@vghks.org.tw), ref: VGHKS16-CT7-08 |
| Health condition(s) or problem(s) studied | Prevention of urinary tract infections in post-stroke patients with urinary catheters |
| Intervention | Early removal of urinary catheters to prevent urinary tract infections The indications for the placement of urinary catheters (UCs) are as follows: (1) patients in critical condition with unstable hemodynamics; (2) postoperative monitoring of urine output; (3) specific surgical procedures requiring urinary catheterization (such as thoracic and pelvic surgery); (4) presence of an open wound around the sacral or perineal area; (5) acute urinary retention; and (6) reaching a consensus among hospice care providers to relieve discomfort through the use of indwelling urinary catheters. The decision to remove UCs was made by nursing-driven circle strategy (NDS) and bladder sonography scan protocol (BSP). NDS was determined through a collaborative effort of surgeons and nurses. On day five of UCs, the nurse leader and registered nurses would meet to discuss the removal timing, with a reminder provided by the ICU's information system (HIS). Following this discussion, the decision to remove the UCs was ultimately made by the surgeons. |
| Intervention type | Other |
| Primary outcome measure(s) |
Successful removal of UCs, determined by the absence of the requirement for another UC to be inserted within 48 hours after the previous UC was removed. The timepoints are May 2014 - April 2016 (control) and May 2016 - August 2018 (testing) |
| Key secondary outcome measure(s) |
1. Diabetes mellitus diagnosis based on standardized laboratory tests and patient records when the patients were admitted to hospital. |
| Completion date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 142 |
| Key inclusion criteria | Post-stroke patients in the Neurosurgery Intensive Care Unit |
| Key exclusion criteria | 1. Patients who suffered from spinal diseases 2. History of prostate cancer or benign prostatic hyperplasia (BPH) 3. Participation refused by surgeons |
| Date of first enrolment | 01/05/2014 |
| Date of final enrolment | 01/08/2018 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung
813
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| IPD sharing plan | The dataset is not expected to be made available because of the regulation of the Ministry of Health in Taiwan. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/07/2023: Study's existence confirmed by the IRB of Kaohsiung Veterans General Hospital.
