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CTRI Number  CTRI/2024/05/066970 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Obervational Study 
Study Design  Other 
Public Title of Study   A prospective observational study to find out the rate of occurrence of accidental catheters ( tubes placed in blood vessel, mouth, nose, and body openings) and their effect on cancer patients admitted in intensive care unit 
Scientific Title of Study   Accidental Catheter removal in Critically ill patients: A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 4446 Version 1.0 Dated 15 March 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr Earnest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr Earnest Borges Road, Parel


MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Abhisheksingh Rajput 
Designation  Senior Resident 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesia, Critical care and Pain, Main Building, second Floor, Tata Memorial Hospital, Dr Earnest Borges Road, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9426257768  
Fax    
Email  geetarajput315@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Road, Parel, MUmbai, Maharashtra 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Singh Rajput  Tata Memorial Hospital, Mumbai  Room No MB 111 and MB 211, Intensive care Units, First Floor, Main Bulilding, Tata Memorial Hospital, Dr E Borges Road, Parel,Mumbai
Mumbai
MAHARASHTRA 
9426257768

geetarajput315@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D099||Carcinoma in situ, unspecified, (2) ICD-10 Condition: Y658||Other specified misadventures during surgical and medical care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients admitted to the ICU during the study period who have an indwelling catheter. 
 
ExclusionCriteria 
Details  Those patients who do not have indwelling catheters 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of ACR per 100 catheters & 100 catheter days will be measured  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Factors that led to accidental Catheter Removal  6 months 
Consequences of Accidental Catheter removal  6 months 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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)   15/05/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Catheters are necessary for medicine delivery, hydration management, monitoring, and nourishment in critically sick patients. However, accidental catheter removal (ACR) has gotten less attention because to the sudden and severe side effects, which include disturbances in medicine delivery, hydration management, and patient stability. ACR might cause life-threatening conditions during removal and reinsertion, which increases healthcare expenditures. Complications may develop depending on the catheter location, including interruptions in medication supply, renal replacement treatment, persistent bleeding, lack of oxygen supply, heart related side effects, escape of fluides in wind pipe and lungs, and death.

Factors contributing to ACR include patient organic confusion, secure device techniques, and the unit’s general safety culture. ACR measurement and prevention are critical for decreasing it. The current study aims to determine the incidence of ACR for all catheter types used in Tata Memorial Hospital’s intensive care unit and develop targeted interventions to reduce ACR, such as staff education on securement techniques, regular catheter assessments, the use of appropriate catheter securement devices, and monitoring compliance with best practices.

 

We are conducting this prospective observational audit in all patients admitted in ICU to check the rate of occurance of accidental catheter removal, their causes and the side effects occuring due to it. The study will be conducted at two ICUs (FICU & SICU) at Tata memorial hospital Mumbai.

 We will try to find out the rate of occurance of accidental catherer removel per 100 catheter inserted and per 100 catheter days, factor that led to catherer removal and complications associated with them.

In this study, we will enroll all patients admitted in the ICU in a period of six month. Start date of the study enrollment will be immedialy after obtaining the IEC approval and CTRI registration. Based on recent ICU admission data, a total of 1500 admissions are expected in the ICU over a 6-month period. All patietns admitted to the ICU durring the study period who have an indewelling catheter will be enrolled in the study. As patients admitted in ICU are seriosly ill and under deep sedation consent will be obtained from the patient’s relative or legally acceptable representative before starting the data collection.

 
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