| 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
|
|
|
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
|
|
|
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. |