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CTRI Number  CTRI/2025/09/095201 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   An observational study to calculate the incidence and risk factors for arterial cannulation failure in critical care unit patients 
Scientific Title of Study   Incidence and Risk Factors for Arterial Cannulation Failure in Critical Care Unit Patients: An 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 ANKUR 
Designation  Post Graduate Student 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anaesthesiology, AIIMS Rishikesh, Veerbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  7840034512  
Fax    
Email  ankur.mamc17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankit Agarwal 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Depart of Anaesthesiology, AIIMS Rishikesh, Veerbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9761966555  
Fax    
Email  Drankit80@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankur 
Designation  Post Graduate Student  
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of Anaesthesiology, AIIMS Rishikesh, Veerbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  7840034512  
Fax    
Email  ankur.mamc17@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203  
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Veerbhadra Road, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203  
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 Ankur  All India Institute of Medical Sciences  Department of Anaesthesiology, AIIMS Rishikesh, Veerbhadra road, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL 		 7840034512

ankur.mamc17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Rishikesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adult patients of age more than 18 years of both genders coming to Critical Care Unit with arterial cannulation done in Critical Care Unit or outside within 24 hours of shifting to Critical Care Unit. 
 
ExclusionCriteria 
Details  1 Patient refusal
2 Peripheral Vascular Disease
3 Failed Allen’s test or Poor collateral circulation
4 Patient with Arteriovenous Fistula
5 Established Blood Infection (less than 48 hours)
6 Local site infection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the incidence of arterial cannulation failure in critical care unit patients  5 days from day of CCU admission 
 
Secondary Outcome  
Outcome  TimePoints 
Failure of arterial cannulation due to thrombosis  5 days from day of CCU admission 
Failure of arterial cannulation due to complete occlusion   5 days from day of CCU admission 
Failure of arterial cannulation due to catheter associated bloodstream infection/ CABSI  5 days from day of CCU admission 
Failure of arterial cannulation due to accidental or Self removal  5 days from day of CCU admission 
Failure of arterial cannulation due to non-standard site in comparison to standard site  5 days from day of CCU admission 
Failure of arterial cannulation due to pain at the site of cannulation or Patient discomfort  5 days from day of CCU admission 
Failure of arterial cannulation due to catheter fracture  5 days from day of CCU admission 
To compare the incidence of arteria cannulation failure in patients with CCU stay of less than 72 hours with those with more than or equal to 72 hours to 120 hours  5 days from day of CCU admission 
To compare the incidence of arteria cannulation failure in patients on mechanical ventilation with those not on mechanical ventilation  5 days from day of CCU admission 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   15/10/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   This prospective observational study aims to determine the incidence and risk factors associated with arterial cannulation failure in patients admitted to the Critical Care Unit. The primary outcome is to assess the overall incidence of arterial cannulation failure. Secondary objectives include evaluating specific causes of failure such as thrombosis, occlusion, catheter-associated bloodstream infection (CABSI), accidental or self-removal, non-standard site placement, patient discomfort or pain, and catheter fracture. The study will also compare failure rates in relation to duration of CCU stay (less than 72 hours vs 72 to 120 hours) and the need for mechanical ventilation. Findings are expected to help identify modifiable risk factors and improve patient safety and resource utilization in critical care settings. 
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