CTRI Number |
CTRI/2025/05/087303 [Registered on: 21/05/2025] Trial Registered Prospectively |
Last Modified On: |
20/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
To Know effectiveness of Physical Examination of Oral cavity , Neck and Ultrasound Examination of Neck to Predict Difficulty of placing Tube into Trachea for Giving General Anesthesia |
Scientific Title of Study
|
Difficult airway prediction using Clinical and Ultrasound airway assessment parameters: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 |
Thamizhanban D |
Designation |
Post Graduate Registrar |
Affiliation |
Christrian Medical College |
Address |
Department of Anesthesia
Paul Brand Building (new)
Christian Medical College hospital -Town campus
Vellore
Vellore TAMIL NADU 632004 India |
Phone |
8870463057 |
Fax |
|
Email |
thamsblack@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Smitha Elizabeth George |
Designation |
Professor |
Affiliation |
Christrian Medical College |
Address |
Department of Anesthesia
Paul Brand Building (new)
Christian Medical College hospital -Town campus
Vellore
Vellore TAMIL NADU 632004 India |
Phone |
9655820582 |
Fax |
|
Email |
smitha.lizgeorge@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Thamizhanban D |
Designation |
Post Graduate Registrar |
Affiliation |
Christrian Medical College |
Address |
Department of Anesthesia
Paul Brand Building (new)
Christian Medical College hospital -Town campus
Vellore
Vellore TAMIL NADU 632004 India |
Phone |
8870463057 |
Fax |
|
Email |
thamsblack@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Christian Medical College |
Address |
Research Office, Christrian Medical College, Bagayam, Vellore, Tamil Nadu, 632002 |
Type of Sponsor |
Research institution and hospital |
|
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 Smitha Elizabeth George |
Christian Medical college, Hospital |
Christian Medical college, Hospital, ida Scuddar Road,Thottapalayam Vellore TAMIL NADU |
9655820582
smitha.lizgeorge@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Instituitional Research Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: H701||Chronic mastoiditis, (2) ICD-10 Condition: K432||Incisional hernia without obstruction or gangrene, (3) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (4) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (5) ICD-10 Condition: C20||Malignant neoplasm of rectum, (6) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (7) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
Adults above 18yrs of age , classified as ASA1 and ASA 2 undergoing Elective Surgeries- Plastics Surgeries, Gynaecology Surgeries, Urology Surgeries, General Surgeries, Ortho Surgeries, ENT surgeries under General Anaesthesia in CMC Town Campus and Ranipet Campus requiring intubation for surgeries. |
|
ExclusionCriteria |
Details |
Anticipated Difficult Airway-Pregnant women,Patients with known airway-Oral, pharyngeal, Laryngeal pathologies, Cervical Vertebral diseases, Large Thyroid and Parathyroid Swelling, Submandibular Salivary Gland Pathology, Healed Post Tracheostomy scar, Post Burn Contractures of Neck, or any scar over the neck and patients posted for Oro-Pharyngeo-Laryngeal procedures , Emergency surgeries,Mentally Challenged, Superspeciality Surgery – Neuro Surgery, Cardiothoracic Surgery are excluded from this study. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Predictive Value of Ultrasound Airway Assessment in Difficult Airway |
At time of Induction |
|
Secondary Outcome
|
Outcome |
TimePoints |
Predictive Value of Clinical Airway Assessment in Difficult Airway |
At time of Intubation |
Comparison of Predictive Value of ultrasound Airway assessment with Clinical Airway Assessment for Difficult Airway Prediction |
NIL |
|
Target Sample Size
|
Total Sample Size="175" Sample Size from India="175"
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)
|
02/06/2025 |
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="1" Months="3" 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
|
Difficult Airway Prediction is an important part of pre anaesthesia
assessment as it facilitates planning and preparing to manage a difficult
airway. This in turn will enable a smooth perioperative course and reduced
perioperative morbidity. Conventional physical assessment for difficult airway
can sometimes fail to identify a difficult airway. This has made Point of Care
Ultrasonography (POCUS) as an evolving tool for airway assessment.
In this study, both Male and Female Patients above 18yrs of
Age, Classified as per American Society of Anaesthesiologist as ASA1,ASA 2,
posted for Elective Surgeries planned under General Anaesthesia using
endotracheal intubation are included. Pregnant women, Patients with known
airway (Oral, pharyngeal, Laryngeal) pathologies, Cervical Vertebral diseases,
Large Thyroid and Parathyroid Swelling, Submandibular Salivary Gland Pathology,
Healed Post Tracheostomy scar, Post Burn Contractures of Neck, or any scar over
the neck and patients posted for Oro-Pharyngeo-Laryngeal procedures and
Emergency surgeries are excluded from this study.
In this study, after consent for the study, the airway
physical assessment using SARI scoring is evaluated preoperatively.
Preoperatively (before Intubation) On the day of Surgery, in the operating
room, the primary investigator or co-investigator shall measure Distance from
Skin to Epiglottis (DSE)and Hyomental Distance (HMD) with neck neutral, extended and in ramped
positions ,and tongue thickness (TT) using ultrasound, thus completing the
tests in the DARES protocol. It is planned that 15% of Sample size done by the Primary Investigator shall be
validated by Radiologist – Co Investigator. . If the Primary investigator’s
assessment is not comparable to Radiologist - Co Investigator, then patients
assessed by Primary investigator prior shall be dropped and the Primary
Investigator shall be undergoing further training with the co – investigator.
Post Training Primary Investigator will continue the study.
The Senior Anaesthesiologist posted on the elective list who
is not aware of the recorded SARI score
and DARES protocol measurements will intubate the patient and record the IDS
score obtained.
POCUS predictive value in Difficult Airway Assessment using
the DARES protocol, will be calculated and compared with conventional physical
airway assessment using the SARI score The difficulty of airway management will be calculated based on
the IDS score. |