CTRI Number |
CTRI/2025/06/089099 [Registered on: 18/06/2025] Trial Registered Prospectively |
Last Modified On: |
14/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
To identify difficult airway in patients undergoing general anaesthesia by assesing same physical parameter with ultrasound guided parameter |
Scientific Title of Study
|
Diagnostic Accuracy Of Distance From Skin To Epiglottis In Predicting Difficult
Airway Using Ultrasonographic Airway Assessment |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Gayathri P |
Designation |
JUNIOR RESIDENT |
Affiliation |
Chettinad hospital and research institute |
Address |
D block , 1st floor,Department of Anaesthesiology,Chettinad hospital
and research institute,chettinad health city,Rajiv Gandhi Salai( OMR)
,kelambakkam
Chennai TAMIL NADU 603103 India |
Phone |
9884607799 |
Fax |
|
Email |
gayu.jp.98@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrVijay Narayan |
Designation |
Professor |
Affiliation |
Chettinad hospital and research institute |
Address |
D block , 1st floor,Department of Anaesthesiology,Chettinad hospital
and research institute,chettinad health city,Rajiv Gandhi Salai( OMR)
,kelambakkam
Chennai TAMIL NADU 603103 India |
Phone |
7904535573 |
Fax |
|
Email |
vijaynarayanans@care.edu.in |
|
Details of Contact Person Public Query
|
Name |
DrVijay Narayan |
Designation |
Professor |
Affiliation |
Chettinad hospital and research institute |
Address |
D block , 1st floor,Department of Anaesthesiology,Chettinad hospital
and research institute,chettinad health city,Rajiv Gandhi Salai( OMR)
,kelambakkam
Chennai TAMIL NADU 603103 India |
Phone |
7904535573 |
Fax |
|
Email |
vijaynarayanans@care.edu.in |
|
Source of Monetary or Material Support
|
Chettinad hospital and research institute, chettinad health city, Rajiv
Gandhi Salai,Kelambakkam, chennai, Tamilnadu, India-603103 |
|
Primary Sponsor
|
Name |
Chettinad hospital and research insitute |
Address |
Chettinad hospital and research institute, chettinad health city, Rajiv
Gandhi Salai,Kelambakkam, chennai, Tamilnadu, India-603103 |
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 Gayathri P |
CHETTINAD HOSPITAL AND RESEARCH INSITUTE |
D- block , 1st floor,
Department of
Anaesthesiology,
Chettinad Health city,
Chettinad health
city,Rajiv Gandhi Salai,
Kelambakkam, Chennai TAMIL NADU |
9884607799
gayu.jp.98@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL HUMAN ETHICS COMMITTEE ( CARE IHEC- I) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Cormack lehane grading |
To compare Cormack lehane grading during routine laryngoscopy to asses whether the intervention is able to assess the difficult airway preoperatively |
Intervention |
Ultrasound measurement of skin to epiglottis in patients undergoing general anaesthesia |
To preoperatively assess the Ultrasound measurement of skin to epiglottis in patients undergoing general anaesthesia
to find out the diagnostic accuracy of the parameter (skin to epiglottis distance )in assesing difficult airway |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Age: 18-65 years
ASA grade -1,2,3,4
Patients undergoing surgery under
general anaesthesia. |
|
ExclusionCriteria |
Details |
Patients who denies consent
Patients with prominent features of the difficult airway with facial abnormalities
Morbid obesity (body mass index, BMI more than 35 kg/m2)
Restricted mouth opening
Cervical spine anomalies
Uncooperative and pregnant patients |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To compute the diagnostic accuracy of distance from skin to
epiglottis through Ultrasound assessment in predicting difficult airway |
30 minutes |
|
Secondary Outcome
|
Outcome |
TimePoints |
To
assess the sensitivity, specificity, positive predictive value and negative predictive value of the whole study |
6 months |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
30/06/2025 |
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 Yet Recruiting |
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
|
Diagnostic Accuracy Of Distance From Skin To Epiglottis In Predicting Difficult
Airway Using Ultrasonographic Airway Assessment
Introduction One of the prime responsibilities of the anesthesiologist is to provide adequate ventilation by
securing the patient’s airway. Preoperative assesment of the patient’s airway facilitates to
predict the difficult airway The diagnostic precision of a pre-anesthetic airway checkup in
predicting difficult intubation is very low, and unpredicted difficult intubations persist. The
diagnostic accuracy of these pre-anesthetic airway screening parameters has varied results in
various studies. Recently, ultrasound (USG) guided airway assessment is showing encouraging
results. However, few research studies have studied the role of ultrasonographic measurements
in detecting difficult airways preoperatively. The objective behind our study is to search for a
simple and bedside noninvasive method to identify difficult airway As there are only less
number studies predicting difficult airway using this predictor i would like to do my study with
predictor for assesing diffficult airway
OBJECTIVES
Primary objective To compute the diagnostic accuracy of distance from skin to
epiglottis through Ultrasound assessment in predicting difficult airway
secondary objective To
assess the sensitivity, specificity, positive predictive value and negative predictive value
Study design
Prospective observational study Number of subjects/sample size
The minimum sample size for the study has been calculated to 100
Study Methodology or procedure Inclusion criteria : Age: 18-65 years ASA grade -1,2,3,4 Patients undergoing surgery under
general anaesthesia. Exclusion criteria : Patients who denies consent Patients with prominent
features of the difficult airway with facial abnormalities Morbid obesity (body mass index, BMI more than 35 kg/m2) Restricted mouth opening Cervical spine anomalies Uncooperative and pregnant
patients
After obtaining approval from Ethics committee Informed and written consent will be
obtained from all patients • PREOPERATIVE ASSESSMENT: Detailed history and physical
examination, baseline data like HR,BP and basic investigations will be collected. MMP grading
(1,2,3,4),Mouth opening (more or less than 3 finger breath) ,Thyromental distance(more or less
than 6.5 cm) ,Hyomental distance (more or less than 3 finger breath) ,BMI (More or less than 35
Sq.cm) ,Neck circumference (more or less than 34 cm) ,Neck movements (ROM adequate or not
adequate ) will be noted An IV access with 18G IV cannula will be secured for all patients.
Premedication such as Tab Ranitidine 150mg and Tab Alprazolam 0.5mg given a night before
surgery and 6 am on the day of surgery All patients will undergo detailed preoperative
ultrasonographic evaluation. Ultrasonographic airway evaluation will be done with a linear high
frequency probe. The Ultrasonographic measurement of the airway will be achieved with the
patient in supine and the head and neck in the neutral position without a pillow, looking straight
ahead with the mouth closed. Skin to epiglottis distance is noted.
Study outcome or end points
To preoperatively diagnose the difficult airway using ultrasound (skin to epiglottis distance)in
patients undergoing surgery under general anaesthesia. Ethical Considerations
Approval from Chettinad Hospital and Research Institute IHEC (institutional human ethical
committee) has been obtained before starting the study. All participants will be informed regarding
the purpose of study, benefits, procedure and confidentiality of the research study in their local
language and in English. An informed and written consent will be taken from person who willing
to participate in study Study Duration (in Months / Years) 6 months
References 1. Agung Senapathi TG, Wiryana M, Aryabiantara IW, Ryalino C, Roostati RL. The predictive
value of skin-to-epiglottis distance to assess difficult intubation in patients who undergo surgery
under general anesthesia. Bali J Anaesthesiol 2020 4 46 8
2. Harjai M, Alam S, Rastogi S, et al. (July 15, 2023) Effectiveness and Validity of Preoperative
Ultrasonographic Airway Assessment and Clinical Screening Tests to Predict Difficult
Laryngoscopy: A Prospective, Observational Study. Cureus 157 e41933. DOI
10.7759 cureus.4193 3 tests in the evaluation of difficult airways preoperatively
3. Soltani Mohammadi S, Tavakkoli A, Marashi M. Correlation between Ultrasound Measured
Distance from Skin to Epiglottis and Epiglottis to Mid-Vocal Cord with Cormack-Lehane
Classification for Predicting Difficult Intubation. Arch Anesth & Crit Care. 2019 6123 26
4. Udayakumar G, Priya L, Narayanan V (July 05, 2023) Comparison of Ultrasound Parameters
and Clinical Parameters in Airway Assessment for Prediction of Difficult Laryngoscopy and
Intubation: An Observational Study. Cureus 15 7 e41392. DOI 10.7759 cureus.41392 |