Timing of successful removal of urinary catheters in the neurosurgery intensive care unit

ISRCTN	ISRCTN11643929
DOI	https://doi.org/10.1186/ISRCTN11643929
Secondary identifying numbers	VGHKS16-CT7-08

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Wei-Chuan Chen
Scientific

No.386, Da-chung 1st. RD.
Zuoying Dist.
Kaohsiung
813
Taiwan

Phone	+886 (0)73422121
Email	coupe055@ms28.hinet.net

Study information

Study design	Quasi-experimental design trial
Primary study design	Observational
Secondary study design	Case series
Study setting(s)	Hospital
Study type	Prevention, Safety
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	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)
Secondary outcome measures	1. Diabetes mellitus diagnosis based on standardized laboratory tests and patient records when the patients were admitted to hospital. 2. The incidence of catheter-associated urinary tract infections (CAUTIs), calculated according to the guidelines established by the Infectious Diseases Society of America (IDSA) and expressed as the number of CAUTI cases per 1,000 catheter days. The timepoints are May 2014 - April 2016 (control) and May 2016 - August 2018 (testing)
Overall study start date	03/01/2013
Completion date	31/08/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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 Veterans General Hospital

No.386, Da-chung 1st RD., Zuoying Dist.
Kaohsiung
813
Taiwan

Sponsor information

Veterans Affairs Council
Government

No.222, Sec. 5
Zhongxiao E. Rd
Xinyi District
Taipei
110
Taiwan

Phone	+886 (0)2 2725 5700
Email	info@vac.gov.tw
Website	https://www.vac.gov.tw/mp-2.html

Funders

Funder type

Government

Veterans Affairs Council

No information available

Results and Publications

Intention to publish date	31/07/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Not expected to be made available
Publication and dissemination plan	Ready to submit to a high-impact peer-reviewed journal
IPD sharing plan	The dataset is not expected to be made available because of the regulation of the Ministry of Health in Taiwan.

Editorial Notes

11/07/2023: Study's existence confirmed by the IRB of Kaohsiung Veterans General Hospital.