| CTRI Number |
CTRI/2025/02/079905 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Perfusion index to monitor blood flow changes during airway procedures in patients under general anaesthesia And its comparison with noninvasive blood pressure and heart rate |
|
Scientific Title of Study
|
Perfusion index as a noninvasive parameter to measure hemodynamic response during larngoscopy in a patient posted under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VRAJ SHAH |
| Designation |
Resident doctor |
| Affiliation |
Surat municipal institute of medical education and research |
| Address |
1st floor , Department of Anaesthesiology , Surat institute of medical education and research, near sahara darwaja , umarwada , surat ,gujarat, india ,395010
Surat
GUJARAT
395010
India |
| Phone |
8490076796 |
| Fax |
|
| Email |
Vraj.shah97@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neepa patel |
| Designation |
Associate professsor |
| Affiliation |
Surat municipal institute of medical education and research |
| Address |
1st floor , Department of Anaesthesiology , Surat institute of medical education and research, near sahara darwaja , umarwada , surat ,gujarat, india ,395010
Surat
GUJARAT
395010
India |
| Phone |
9825729055 |
| Fax |
|
| Email |
drnpatelmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vraj shah |
| Designation |
Resident Doctor |
| Affiliation |
Surat municipal institute of medical education and research |
| Address |
1st floor , Department of Anaesthesiology , Surat institute of medical education and research, near sahara darwaja , umarwada , surat ,gujarat, india ,395010
Surat
GUJARAT
395010
India |
| Phone |
8490076796 |
| Fax |
|
| Email |
vraj.shah9797@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1st floor department of anaesthesia surat municipal institute of medical education and research near sahara darwaja, umarwada , surat , gujarat , india , 395010
near |
|
|
Primary Sponsor
|
| Name |
dr vraj shah |
| Address |
1st floor , Department of Anaesthesiology , Surat institute of medical education and research, near sahara darwaja , umarwada , surat ,gujarat, india ,395010 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Neepa patel |
B/504 shubham apartment , near sangam society , city light road , surat 395007 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr vraj shah |
surat municipal institute of medical education and research |
1st floor-hospital building,Department of Anaesthesiology, Surat institute of medical education and research, near sahara darwaja , umarwada , surat ,gujarat, india ,395010
Surat
GUJARAT |
8490076796
vraj.shah9797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMER IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening of hemodynamic using perfusion index in healthy volunteers/ patients ( ASA 1/2 ) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
perfusion index during intubation and extubation using conventional laryngoscope |
oral intubation using laryngoscopy will be done in each patient
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I AND II
Type Of Surgery-surgical procedure requiring general anaesthesia
mallampati score 1 and 2 , upper lip bite test class 1 , hyomental distance greater than 6 cm.
CLS Grade 1 only |
|
| ExclusionCriteria |
| Details |
patient refusal
parturient females
patients with any neuromuscular disorder
patients with any renal , hepatic disease , IHD and hypertension with/without treatment
BMI greater than 30 kg/m2
known hypersensitivity to drugs used in our study
mallampati score III/IV
difficult intubation :- impending / expected difficult intubation ( Predicted )
patient who gives H/O previous difficult intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of hemodynamic response using perfusion index |
baseline 0 minutes,during laryngoscopy - at the time of intubation , post intubation for 10 minutes, before reversal , during laryngoscopy- at the time of extubation ,post extubation for 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlate change in hemodynamic parameters with perfusion index |
baseline 0 minutes,during laryngoscopy - at the time of intubation , post intubation for 10 minutes, before reversal , during laryngoscopy- at the time of extubation ,post extubation for 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The Perfusion Index (PI) is the ratio of the pulsatile to the non-pulsatile signal obtained from the pulse oximetry wave-form that is incorporated in several modern pulse oximeter monitors available in operating theatres.
It decreases with vasoconstriction and increases with vasodilatation, and several studies have suggested that the PI may be a sensitive estimate of the level of hemodynamic activity, as it indicates the status of the microcirculation which is densely innervated by sympathetic nerves, so our purpose is to check the findings of previous studies and to decide whether PI can be used as noninvasive parameter to measure hemodynamic response or not. PI has been used to predict low blood pressure, identify early success indicators of central and peripheral nerve block effect assessment, evaluate systemic vascular resistance, indicate the success of sympathectomy and identify the incidence of hypotension after spinal anaesthesia In our study ,We will check PI as non invasive parameter for hemodynamic response with the help of changes in perfusion index during Laryngoscopy Recruitment of patients will start after the CTRI registration |