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CTRI Number  CTRI/2024/03/064185 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of different catheters blood pressure measurement 
Scientific Title of Study   Comparison of the success rates of different catheter designs for radial artery cannulation in adult patients undergoing surgery-A randomized trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences(AIIMS) Bhopal 
Address  Dept of Anaesthesiology Saket nagar Hospital building AIIMS Bhopal ph 7893562302

Bhopal
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences(AIIMS) Bhopal 
Address  Dept of Anaesthesiology Saket nagar Hospital building AIIMS Bhopal ph 7893562302


MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  S R A N Bhushanam Padala 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences(AIIMS) Bhopal 
Address  Dept of Anaesthesiology Saket nagar Hospital building AIIMS Bhopal ph 7893562302


MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala72@gmail.com  
 
Source of Monetary or Material Support  
AIIMS,Bhopal 
 
Primary Sponsor  
Name  AIIMS,Bhopal 
Address  Saket nagar, Bhopal, Madhya Pradesh,432020 
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 
DrS R A N Bhushanam Padala  AIIMS hospital  Department of Anaesthesia, OT no.5, 3rd floor modular OT complex
Bhopal
MADHYA PRADESH 
07893562302

padala72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Bhopal Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I080||Rheumatic disorders of both mitraland aortic valves,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  radial artery cannulation with arterial leadercath  Patients receive radial artery cannulation through arterial leadercath,VYGON-5 rue Adeline 95440 Ecouen-France Time required for cannulation will be noted 
Comparator Agent  radial artery cannulation with BD cannula  Patients receive radial artery cannulation through Becton Dickinson Infusion Therapy system Inc, 9450 South state Street, Sandy, Utah 84070,USA Time required for cannulation will be noted 
Comparator Agent  radial artery cannulation with IV cannula  Patients receive radial artery cannulation through ported, winged MAISFLON I.V. cannula, FEP radio-opaque catheter Boulevard General Wahis 53, B-1030 Brusseis, Belgium Time required for cannulation will be noted 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adult patients aged 18-65 years of either sex undergoing elective cardiac surgery under general anesthesia who are willing to participate in the trial 
 
ExclusionCriteria 
Details  Patients with contraindications for radial artery cannulation like local site of infection, gangrene, aneurysms. etc
Chronic Kidney disease patients with arterio-venous fistulas
Patients with bilateral amputated upper limbs
Patients with psychiatric problems who are uncooperative for radial artery cannulation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
first attempt success rate of different catheter designs for radial artery cannulation in adult patients undergoing cardiac surgery  after completion of radial artery cannulation
 
 
Secondary Outcome  
Outcome  TimePoints 
the time taken for cannulation of different catheter designs for radial artery cannulation in adult patients undergoing cardiac surgery
the number of attempts for cannulation of different catheter designs for radial artery cannulation in adult patients undergoing cardiac surgery
the post insertion complications for different catheter designs for radial artery cannulation in adult patients undergoing cardiac surgery
 
after completion of radial artery cannulation
48 hours after insertion of radial artery catheter 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 4 
Date of First Enrollment (India)   30/03/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [padala72@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

There are several types of catheters in usage for radial artery cannulation in cardiac surgical patients. Research is needed to assess the existing catheter designs and develop a catheter with better design for radial artery cannulation in cardiac surgical patients. Although, success rates of different catheter types were compared for peripheral venous cannulation, to the best of our knowledge, there haven’t been any studies done yet to compare these various catheter designs for radial artery cannulation. We believe, this study would through some light in that direction and help in future trials.

 

 

Relevance of the research question and potential clinical applicability of the outcomes

                                       

                                       If we can find out the better catheter design for radial artery cannulation, it can be employed uniformly in clinical practice. Catheters with better design are likely to be easy to place with less complications. Patients will be more comfortable and less anxious with better catheter design as it is likely to take less time for placement. It would be very helpful, especially in cardiac surgical patients where tachycardia due to anxiety of the patients is detrimental. We feel, catheter with better design would help in maintaining hemodynamic stability in patients undergoing cardiac surgery, where radial artery cannulation in awake patients under local anaesthesia is a routine.

 

 

 

Background

                                      Cannulation of radial artery is a routine practice in cardiac surgical patients before induction of anesthesia.[1] It allows beat to beat monitoring of blood pressure and as a sampling access to the arterial blood gas monitoring.[2] It also helps in titration of anesthetic medications while maintaining hemodynamic stability which is of prime importance in anesthetic induction of cardiac surgical patients.[3] Although, under local anesthesia, radial artery cannulation in awake patient can cause unwanted anxiety and tachycardia. Various types of catheters are in use for radial artery cannulation in cardiac surgical patients.The objective of this study is to compare the success rates of three commonly used catheters in India for radial artery cannulation, namely arterial leadercath,VYGON-5 rue Adeline 95440 Ecouen-France(Group L), BD arterial cannula, Becton Dickinson Infusion Therapy system Inc, 9450 South state Street, Sandy, Utah 84070,USA(Group B) and ported, winged MAISFLON I.V. cannula, FEP radio-opaque catheter  Boulevard General Wahis 53, B-1030 Brusseis, Belgium(Group I). [Figure 1] Although I.V. cannulas are not supposed to use for arterial cannulation, they have been in use in many centers because of its easy availability and low cost. It should be labelled properly and the injection port on the top of the IV cannula should be closed to prevent inadvertent administration of drugs into arterial system. [4,5]

 

Figure 1: Catheters with different designs for radial artery cannulation. (From left to right:  VYGON arterial leadercath, BD arterial cannula, MAISFLON I.V. cannula)

 

 

 

 

 

Methodology including technical description

 

Type of the study: A prospective randomized trial

Set-up: All India Institute of Medical Sciences, Bhopal which is a tertiary care teaching hospital

Patient inclusion criteria:

1.     All adult patients aged 18-65 years of either sex undergoing elective cardiac surgery under general anesthesia who are willing to participate in the trial

Patient exclusion criteria:

1.     Patients with contraindications for radial artery cannulation like local site of infection, gangrene, aneurysms. etc

2.     Chronic Kidney disease patients with arterio-venous fistulas

3.     Patients with bilateral amputated upper limbs

4.     Patients with psychiatric problems who are uncooperative for radial artery cannulation

 

 

 

 

                                This will be a prospective randomised trial conducted on adult patients of either sex, between 18-65 years undergoing cardiac surgery under general anesthesia at All India Institute of Medical Sciences, Bhopal, India. Institutional human ethics committee approval will be obtained before starting the trial. Patient’s information sheet will be handed over to all the subjects three to five days prior to the scheduled procedure. The written and informed consent for the conduct of the study will also be obtained three to five days prior to the surgery from all the subjects, after explaining the procedure. All patients will be given oral tablet alprazolam 0.25 mg on the previous night and on the morning of surgery. Fasting for solids will be for 6 hours and clear liquids will be for 2 hours. All patients will be encouraged to take clear liquids up to two hours prior to surgery.

 

                                  Block randomization will be done to allocate the enrolled patients into one of the three groups.  Patients in group L, group B and group I will receive arterial leadercath, BD arterial cannula and ported, winged I.V. cannula respectively for radial artery cannulation. On arrival to the operating room, standard monitors will be attached and baseline recordings of vital parameters will be noted. All the radial artery cannulations will be done under aseptic precautions using local anesthesia(0.5 mL of 2% lignocaine). Physicians having at least 3 years of training in anesthesia will be the operator in all the patients. The technique of insertion will be left to the discretion of the operator. Duration from the point of skin prick to the complete threading of catheter into the radial artery will be defined as “ time taken for cannulation”. Data regarding the number of attempts required for successful radial artery cannulation will be documented. Any complications during the procedure like catheter kinks, catheter tears, needle stick injuries to the operator or any other complication will be noted. Any complications in the post insertion period will also be noted and compared among different catheter designs.

 

                                 Sample size and statistical analysis: This, being a pilot project, we are considering a sample size of 40 in each group. Quantitative data will be expressed in mean and standard deviation, qualitative data will be expressed in percentage. P < 0.05 will be considered statistically significant.

 
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