| CTRI Number |
CTRI/2023/08/056536 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Bladder discomfort because of urinary catheter in patients undergoing cardiothoracic surgeries |
|
Scientific Title of Study
|
Incidence of post-operative catheter related bladder discomfort in adult patients undergoing cardiac and thoracic surgeries: a prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor of Anesthesiology and Critical Care |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409
Department of Anesthesiology and Critical Care
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor of Anesthesiology and Critical Care |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409
Department of Anesthesiology and Critical Care
AIIMS Bhubaneswar
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor of Anesthesiology and Critical Care |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room No 409
Department of Anesthesiology and Critical Care
AIIMS Bhubaneswar
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Satyajeet Misra |
| Address |
Room no 409
Department of Anesthesiology and Critical Care
AIIMS Bhubaneswar |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satyajeet Misra |
AIIMS Bhubaneswar |
Department of Anesthesiology and Critical Care
Khordha
ORISSA |
9438884048
misrasatyajeet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-70 years, of either gender.
2. Scheduled for elective cardiac or thoracic surgery.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Patients who are unable to be extubated on POD-1 since CRBD incidence, especially mild CRBD is a questionnaire based assessment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of CRBD using the CRBD scale. |
Two hours & six hours after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of severe CRBD defined as CRBD scores of more than two |
Two hours & six hours after extubation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Presence of a catheter leads to catheter related bladder discomfort (CRBD) in 47-90% of patients. CRBD manifests as supra-pubic discomfort or a burning sensation, urinary urgency, frequency, and may be associated with the act of attempting to pull out the urinary catheter. Risk factors for CRBD include uro-gynecological surgeries, male gender, and Foley’s catheter greater than 18 Fr. Urinary catheterization is mandatory in patients undergoing cardiac surgery. No previous studies have documented the incidence of CRBD in patients undergoing cardiac surgery. This would be useful to know since patient discomfort due to CRBD may not only be distressing to the patient, but also may precipitate myocardial ischemia or increase the risk of bleeding due to increased sympathetic activity and/or patient agitation. Furthermore, knowing the baseline incidence would allow for institution of pharmacological options to treat the same. Thus, the aim of this study will be to evaluate the incidence and severity of CRBD in patients undergoing cardiothoracic surgery. Sub-group analyses will be carried out to assess the incidence and severity separately in cardiac and thoracic procedures. |