FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/12/007534 [Registered on: 05/12/2016] Trial Registered Retrospectively
Last Modified On: 11/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of two different methods of radial artery cannulation in patients posted for emergency surgery 
Scientific Title of Study   Comparison of direct and guide-wire assisted techniques of radial artery cannulation in patients posted for emergency surgery- a randomized clinical trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  N C Pankaj Kumar 
Designation  Junior Resident 
Affiliation  JIPMER, Pondicherry 
Address  Department of Anesthesiology and Critical Care, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone    
Fax    
Email  pankaj.chakri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  N C Pankaj Kumar 
Designation  Junior Resident 
Affiliation  JIPMER, Pondicherry 
Address  Department of Anesthesiology and Critical Care, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone    
Fax    
Email  pankaj.chakri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  A Vasudevan 
Designation  Additional Professor 
Affiliation  JIPMER, Pondicherry 
Address  Department of Anesthesiology and Critical Care, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone    
Fax    
Email  jipmervasu@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Institute Fund, JIPMER, Pondicherry 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  JIPMER, PONDICHERRY, INDIA - 605006 
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 
N C PANKAJ KUMAR  Jawaharlal Institute of Postgraduate Medical Education and Research  Emergency Operation Theater, 2nd floor, EMS and Trauma center, JIPMER, Pondicherry, INDIA- 605006
Pondicherry
PONDICHERRY 
8098030880

pankaj.chakri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I958||Other hypotension, Patients posted for emergency surgery in whom arterial blood pressure monitoring and arterial blood gas analysis is required,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group C  Radial artery cannulation with arterial cannula. 
Comparator Agent  Group G  Radial artery cannulation with arterial guide-wire catheter.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients of either gender, presenting with
emergency surgical conditions requiring invasive blood pressure monitoring or frequent arterial blood gas measurements.
 
 
ExclusionCriteria 
Details  1. Patients with inadequate ulnar collateral
circulation identified by performing modified Allen’s test.
2. Patients/patient surrogates who don’t give valid informed consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare success rate of cannulation on first attempt between the two techniques.

 
18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of attempts taken for cannulation between the two techniques.  18 months 
2. Time taken for a successful cannulation between the two techniques.  18 months 
3. Overall success rate of cannulation with the two techniques.
 
18 months 
 
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)   05/05/2014 
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)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

               Invasive arterial pressure monitoring and frequent blood gas analysis have become essential components for physiologic optimization and anesthesia management of emergency surgical procedures in patients presenting with major blood loss or sepsis. Radial artery is used commonly for cannulation as it is easily accessible and associated with less incidence of post-cannulation complications (1). Various techniques exist for arterial cannulation like the direct over-the-needle cannulation(2,3,4), guide-wire assisted catheterization(2,3,4), liquid stylet technique(5), and ultrasound-guided catheterization(6).

              Previous studies have shown that radial artery cannulation with guide-wire assistance was more successful compared to the direct technique in patients undergoing various cardiovascular and neurosurgical procedures in the elective set-up, done by staff anesthesiologists (3, 4). In the emergency surgical suite the arterial cannulations are mostly done by residents with limited experience and the direct cannulation is the most common technique employed. However the direct cannulation technique may be difficult in patients with low arterial pressure, requiring multiple attempts and causing considerable delay. The purpose of this study is to assess whether arterial cannulation can be achieved faster, with fewer attempts, using the guide-wire assisted technique.

 
Close