| CTRI Number |
CTRI/2018/02/011745 [Registered on: 07/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Randomised Comparative Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of windpipe characteristics by ultrasound versus conventional measurements of neck, to predict ease of putting tube in windpipe for ventilator purpose. |
|
Scientific Title of Study
|
Prediction of difficult intubation by airway assessment using ultrasound v/s conventional bed side screening tests: A prospective observational randomized comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rumit Sood |
| Designation |
DNB Anaesthesia resident |
| Affiliation |
Fortis hospital Mohali |
| Address |
Fortis Hospital
Phase-8 sector-62
Mohali
Punjab
Fortis Hospital
Phase-8 sector-62
Mohali
Punjab
Chandigarh
CHANDIGARH
160062
India |
| Phone |
7526838508 |
| Fax |
7526838508 |
| Email |
rumitsood.111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAmit Kumar |
| Designation |
senior consultant (Anaesthesia) |
| Affiliation |
Fortis hospital Mohali |
| Address |
Fortis hospital
phase -8
sec- 62
Mohali
202 C
Sec-24 A
Chandigarh
Chandigarh
CHANDIGARH
160062
India |
| Phone |
9815607478 |
| Fax |
|
| Email |
dramitnagpal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Student Rumit Sood Guide Dr Amit Kumar |
| Designation |
DNB Anaesthesia resident |
| Affiliation |
Fortis hospital Mohali |
| Address |
Fortis hospital
Phase 8
sec 62
Mohali
202 C
SEC-24 A
Chandigarh
Chandigarh
CHANDIGARH
160062
India |
| Phone |
7526838508 |
| Fax |
|
| Email |
rumitsood.111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fortis Hopital Mohali
Punjab |
|
|
Primary Sponsor
|
| Name |
Fortis Hospital |
| Address |
Phase 8
sec - 62
Mohali
Punjab |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Rumit Sood |
Fortis Hospital |
Anaesthesia department
Multispeciality OT
Phase 8
sec - 62
Mohali
Punjab
Chandigarh
CHANDIGARH |
7526838508
rumitsood.111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| fortis hospital mohali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
1.Patients undergoing elective surgery under general
anaesthesia requiring Endotracheal intubation
2.Patients of either sex in the age group of 18 – 65 years.
3.ASA grades I or II.
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective surgery under general
anaesthesia requiring Endotracheal intubation
2.Patients of either sex in the age group of 18 – 65 years.
3.ASA grades I or II.
|
|
| ExclusionCriteria |
| Details |
1.Emergency surgeries.
2.ASA grades III-VI
3.Pregnant patients.
4.Patients with known abnormalities or obvious malformations of the airway with head and neck trauma.
5.Cervical spine pathology or patients scheduled for fibre-optic intubation.
6.Uncooperative or altered sensorium patients.
7.Age <18 years and >65 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Comparison of conventional bedside screening tests and Ultrasound parameters for predicting difficult intubation. |
Preoperative one time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2017 |
| Date of Study Completion (India) |
01/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
pre anesthetic evaluation of the airway will be done prior to the surgery. patient airway will be assessed by the conventional factors in grp 1 and by ultrasound in grp 2. following bed side screening test used for airway assessment in grp 1 : 1. modified mallampati score 2.neck circumference. 3.Thyromental distance. Following ultrasoun parameters used in group 2 : 1. tongue base thickness. 2.anterior neck soft tissue at the level of hyoid bone. 3.anterior neck soft tissue at the level of epiglottis. 4.anterior neck soft tissue at the level of vocal cords. after Airway assessment, patient is induced with fentanyl 2-3mcg/kg and propofol 2mg/kg and Rocuronium 0.6mg/kg. Direct laryngoscopy performed by senior anesthetist who will be blinded to the pre operative airway assessment and Cormack lehane grade noted. After intubation patient is attached to the ventilator and anesthesia is maintained by inhalational agent and fresh gas flow of 2l/min. |