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
|
|
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
|
|
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.
|