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CTRI Number  CTRI/2023/09/057290 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 11/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To study changes in finger blood flow and blood pressure during placement and removal of tube in windpipe under general anaesthesia 
Scientific Title of Study   Assessment of variations in perfusion index derived from photoplethysmography during tracheal intubation and extubation in adult patients undergoing elective surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anil Kumar Yadav 
Designation  Postgraduate student 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  8750387380  
Fax    
Email  yanilkumar98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smita Prakash 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  9810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Smita Prakash 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  9810347125  
Fax    
Email  drsunilprakash@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 
 
Primary Sponsor  
Name  Safdarjung Hospital 
Address  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 
Type of Sponsor  Government 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 
Dr Smita Prakash  Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi  Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi
South
DELHI 
26198462

drsunilprakash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients, aged 18 - 65 years, belonging to American Society of Anesthesiologists Physical Status I scheduled for elective surgery under general anaesthesia with tracheal intubation 
 
ExclusionCriteria 
Details  1.Patients with cardiovascular disease, hepatic or renal disease or diabetes mellitus
2.Anticipated difficult airway
3.Perioperative use of vasopressor
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the changes in perfusion index during tracheal intubation & extubation in adult patients undergoing elective surgery under general anaesthesia using pulse oximeter  0,1,2,3,4,5,6,7,8,9, 10 min intubation
0,1,2,3,4,5 min extubation

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the haemodyanamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation) during tracheal intubation & extubation
2. To correlate changes in perfusion index with changes in haemodynamic parameters during tracheal intubation and extubation
 
0,1,2,3,4,5,6,7,8,9,10 min
0,1,2,3,4,5 min 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

The Perfusion index (PI) is a continuous, non-invasive, cost effective, indirect measure of peripheral perfusion, monitored by photoplethysmography. It has been suggested that PI can be used as a complimentary haemodynamic parameter for early detection of haemodynamic instability in trauma and critically ill patients, in lieu of it being a valuable adjunct for early detection of acute hemodynamic responses to central hypovolemia. Stress response during intubation and extubation during general anaesthesia is known to cause a change in the peripheral vasomotor tone, leading to haemodynamic changes. There is an associated increase in heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP). This increase in the peripheral vasomotor tone, leads to a decrease in peripheral perfusion, and is thereby, expected to cause an associated fall in the PI. There is paucity of literature with regard to changes in perfusion index and haemodynamic parameters during tracheal intubation and extubation in adult patients undergoing elective surgery under general anaesthesia. Our study hypothesis is that perfusion index  changes  with haemodynamic parameters during tracheal intubation and extubation in adult patients undergoing elective surgery under general anaesthesia. The aim of our study is to study changes in  perfusion index and haemodynamic parameters   during tracheal intubation and extubation in adult patients undergoing elective surgery under general anaesthesia.

 
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