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CTRI Number  CTRI/2021/07/035209 [Registered on: 28/07/2021] Trial Registered Prospectively
Last Modified On: 10/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   to study effects of radial artery cannulation with intrarterial catheter on perfusion. 
Scientific Title of Study   Impact of radial artery cannulation on perfusion index 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishith Govil 
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical & Health Sciences 
Address  Ground Floor Department of Anaesthesiology South Block
Patelnagar Dehradun
Dehradun
UTTARANCHAL
248001
India 
Phone  8126101759  
Fax    
Email  nishithgovil@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nishith Govil 
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical & Health Sciences 
Address  Ground Floor Department of Anaesthesiology South Block
Patelnagar Dehradun
Dehradun
UTTARANCHAL
248001
India 
Phone  8126101759  
Fax    
Email  nishithgovil@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Nishith Govil 
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical & Health Sciences 
Address  Ground Floor Department of Anaesthesiology South Block
Patelnagar Dehradun
Dehradun
UTTARANCHAL
248001
India 
Phone  8126101759  
Fax    
Email  nishithgovil@rediffmail.com  
 
Source of Monetary or Material Support  
Shri Guru Ram Rai Institute of Medical & Health Sciences Ground Floor Department of Anaesthesiology South Block Shri Mahant Indiresh Hospital Dehradun Uttarakhand 
 
Primary Sponsor  
Name  Shri Guru Ram Rai Institute of Medical Health Sciences 
Address  Patel nagar Dehradun 
Type of Sponsor  Private medical college 
 
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 
Nishith Govil  Shri Guru Ram Rai Institute of Medical & Health Sciences  Ground Floor Department of Anaesthesiology South Block Patelnagar Dehradun
Dehradun
UTTARANCHAL 
8126101759

nishithgovil@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGRRIM&HS DEHRADUN   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure, (2) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure, (3) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients undergoing surgery and requiring blood pressure monitoring 
 
ExclusionCriteria 
Details  Peripheral vascular diseases upper limb surgeries planned radial artery harvesting recent trans radial intervention, recent acute myocardial infarction or percutaneous coronary intervention (PCI), active malignancy, autoimmune disease, bleeding disorders, recent stroke, functional impairment of the non-dominant arm, pregnancy, severe anemia or thrombocytopenia.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective is to determine the impact of radial artery cannulation on delta change in digital perfusion index  pre insertion, 1, 10, 30 mins after insertion 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objectives is to study change in perfusion index with time (pre insertion, 1, 10, 30 mins after insertion) after radial artery cannulation and to compare perfusion index in cannulated and non-cannulated hand as well as in different digits  pre insertion, 1, 10, 30 mins after insertion 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   02/08/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After getting approval from institutional ethical committee, written informed consent will be obtained from all those patients and/or attendants  who will fulfill the inclusion criteria. Exclusion criteria are age <18 or >90, Peripheral vascular diseases  upper limb surgeries planned radial artery harvesting recent trans radial intervention, recent acute myocardial infarction or percutaneous coronary intervention (PCI), active malignancy, autoimmune disease, bleeding disorders, recent stroke, functional impairment of the non-dominant arm, pregnancy, severe anemia or thrombocytopenia. Radial artery cannulation will be done in the non-dominant hand of the subject using catheter-over-needle technique - 20-gauge, 1.75-in. (4.45-cm) polyurethane catheter over 22-gauge introducer needle or catheter-over-wire technique (modified Seldinger) - 20-gauge peripheral artery catheter kit with integrated wire and catheter. Perfusion index will be measured using hand held pulse oximeter placed on the index finger 1 minute before the intervention (baseline) and  at 1, 10 and 30 minutes after the intervention. The PI ratio will be calculated as the ratio between the PI at 10 minutes after intervention and the baseline PI. Comparison between the values of PI  before and after the intervention will be done and statistically assessed. A comparison between the cannulated and non cannulated limb will also be performed in every patient.

 

 
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