| CTRI Number |
CTRI/2024/10/075210 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to predict response to intubation, starting of surgery and extubation. |
|
Scientific Title of Study
|
Perfusion Index during Endotracheal Intubation, Surgical Incision and Extubation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Liya Mary Joy |
| Designation |
Post Graduate |
| Affiliation |
St Johns Medical College |
| Address |
Department of Anaesthesiology. St Johns Medical College
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9539464333 |
| Fax |
|
| Email |
liyamaryjoy123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sathyanarayana P |
| Designation |
Professor |
| Affiliation |
St Johns Medical College |
| Address |
Department of Anaesthesiology. St Johns Medical College
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9448066128 |
| Fax |
|
| Email |
sathyanarayananair@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Liya Mary Joy |
| Designation |
Post Graduate |
| Affiliation |
St Johns Medical College |
| Address |
Department of Anaesthesiology. St Johns Medical College
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9539464333 |
| Fax |
|
| Email |
liyamaryjoy123@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College and Hospital Sarjapur road Koramangala Bengaluru 560034 |
|
|
Primary Sponsor
|
| Name |
St Johns Medical College |
| Address |
Sarjapur Marathahalli road, John Nagar, Koramangala, Bangalore
Pin code 560034 |
| 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 |
| Dr Liya Mary Joy |
St Johns Medical College and Hospital |
Room no.9 2nd floor
operation theatre
complex Department of
Anesthesia Sarjapur
Road Koramangala
Bengaluru 560034
Karnataka India
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9539464333
liyamaryjoy123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St John’s Medical college, Bengaluru |
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 |
| Comparator Agent |
Non invasive hemodynamic parameters. |
To observe difference in non invasive hemodynamic parameters during endotracheal intubaion and extubation. |
| Intervention |
Perfusion Index |
Perfusion Index is calculated as the ratio of the pulsatile blood flow to the non pulsatile blood flow in the peripheral tissues. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1,2 and 3 patients
Patients for elective surgeries under General Anesthesia |
|
| ExclusionCriteria |
| Details |
ASA 4 patients
Pregnant patients
Patients refusal
Patients with severe systemic diseases
Patients with anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the difference between PI as compared to preoperative values. |
1-1 min after intubation
2- 1 min after surgical incision
3- 1 min after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate difference in the non invasive hemodynamic parameters heart rate, SBP,DBP & MAP |
1-1 min after intubation
2- 1 min after surgical incision
3- 1 min after extubation.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
18/10/2024 |
| 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 Applicable |
| 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 - NO
|
|
Brief Summary
|
The perfusion index (PI) is the ratio of the pulsatile blood
flow to the non pulsatile or static blood flow in peripheral tissue. Perfusion
index thus represents a non invasive measure of peripheral perfusion that can
be continuously and non invasively obtained from a pulse oximeter. Perfusion
index is an assessment of pulsatile strength at a specific monitoring site( e.g hand, finger or
foot), and as such perfusion index is an indirect and non invasive measure of peripheral
perfusion. It is calculated by means of pulse oximetry by expressing the
pulsatile signal (during arterial flow) as a percentage of non pulsatile
signal,both of which are derived from the amount of infrared(940nm) light
absorbed.As
the sensitivity of certain pulse oximeters has improved, the fidelity and
reliability of PI has improved to a level where clinicians are beginning to
explore various ways they can utilize PI to care for their patients |