| 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
|
|
|
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
|
|
|
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. |