| CTRI Number |
CTRI/2024/01/061875 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Ultrasound and clinical airway parameters to know difficult laryngoscopy and intubation in adult patients. |
|
Scientific Title of Study
|
Sonographic assessment of airway parameters to predict difficult laryngoscopy and intubation – a comparison with clinical airway predictors in adult patients undergoing elective surgery:A Prospective, observational study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tappa Rabbani |
| Designation |
MD Anaesthesia,senior resident |
| Affiliation |
ESIC medical college and hospital,sanath nagar |
| Address |
ESIC medical college and hospital,department of anaesthesia,4th floor,room number 4001,sanath nagar,hyderabad,telangana-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9160674945 |
| Fax |
|
| Email |
md.rabbani.t@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Gopinath |
| Designation |
MD Anaesthesia, Professor |
| Affiliation |
ESIC medical college and hospital,sanath nagar |
| Address |
ESIC medical college and hospital,department of anaesthesia,2nd floor,room number 2005,sanath nagar,hyderabad,telangana-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9848024306 |
| Fax |
|
| Email |
gopi59@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Gopinath |
| Designation |
MD Anaesthesia,Professor |
| Affiliation |
ESIC medical college and hospital,sanath nagar |
| Address |
ESIC medical college and hospital,department of anaesthesia,2nd floor,room number 2005,sanath nagar,hyderabad,telangana-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9848024306 |
| Fax |
|
| Email |
gopi59@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Esic medical college and hospital,sanath nagar,hyderabad |
|
|
Primary Sponsor
|
| Name |
Esic medical college and hospital |
| Address |
Esic medical college and hospital,sanath nagar,hyderabad,telangana-500038 |
| 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 |
| Tappa Rabbani |
Esic medocal college and hospital |
Esic medocal college and hospital,department of anaesthesia,4th floor,room number 4001,sanath nagar,hyderabad
Hyderabad
TELANGANA |
9160674945
md.rabbani.t@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Esic medical college and hospital and Esic super speciality hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)patients of either gender
2)Aged 18 to 60 years
3)American society of anaesthesiologists (ASA) physical status I and II |
|
| ExclusionCriteria |
| Details |
1)patient refusal
2)American society of anaesthesiologists (ASA) physical status III AND IV
3)Any notable swelling in the mouth, head and neck, 4)Facial and cervical spine fractures
5)Emergency intubations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of sonography-based airway assessment parameters as predictors of difficult laryngoscopy and intubation compared with using Cormack–Lehane (CL) grade and intubation difficulty scale respectively |
24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Simultaneous evaluation of predictive ability of clinical airway predictors
2.Comparison of efficacy of clinical and sonographic airway parameters as tools of predicting difficult airway
3.Possible development of a model for prediction of difficult airway
|
six months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
31/01/2024 |
| 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="0"
Months="6"
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
|
PURPOSE :Sonographic assessment of airway
parameters to predict difficult laryngoscopy and
intubation – a comparison with clinical airway predictors in adult patients
undergoing elective surgery.
DESIGN: A Prospective, observational study
PARTICIPANT :patients undergoing elective surgeries with endotracheal intubation under general anesthesia
INTERVENTION:Parameters observed during preoperative assessment:Demographic parameters like Age, Sex,
Weight, Body Mass Index (BMI), ASA status and comorbidities will be
noted.
Clinical Airway assessment-Mouth opening, Neck movements,
Mallampatti grade, thyromental distance, mentohyoid
distance, jaw protrusion and Neck circumference at the level of larynx. Sonographic Airway
assessment: Patient will be sitting with head in
the neutral position, looking straight with the mouth closed and the tongue on
the floor of the mouth without any movement. With the transducer placed at the
submandibular area in the sagittal and
transverse planes. Sonographer will be blinded to clinical airway predictors
and Cormack-Lehane grades.Parameters to be seen are Skin to epiglottis distance- measured at the level of the thyrohyoid membrane
(For difficulty intubation) and Condyle to tragus distance (For prediction of
difficult laryngoscopy). Patients will be then taken inside the
operating room and general anaesthesia with muscle relaxant will be
administered as per institutional protocol and standard of care. Laryngoscope
guided intubation will be performed by anaesthesiologists who will also record Cormack- Lehane grade
and calculate intubation difficulty scale score.
MAIN OUTCOME MEASURES:Improved accuracy in assessing
difficult airway |