| CTRI Number |
CTRI/2023/10/058740 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
16/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation between Preoperative USG Airway Assessment and Ease of Intubation in Cancer Patients - An Observational Study |
|
Scientific Title of Study
|
Correlation between Preoperative Ultrasonographic Airway Assessment and Laryngoscopic View in Oncological Patients - A Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAMITA MOHANDAS |
| Designation |
Post graduate student, MD Anaesthesiology |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room no. 1, Ladies Postgraduate Hostel, Kidwai Memorial Institute of Oncology, Dr. M H Marigowda Road, Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
09845131337 |
| Fax |
|
| Email |
mohandas22namita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V B Gowda |
| Designation |
Medical Superintendent and Head of the Department of Anaesthesiology |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Kidwai Memorial Institute of Oncology, Dr. M H Marigowda Road, Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9845259264 |
| Fax |
|
| Email |
vbchethana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NAMITA MOHANDAS |
| Designation |
Post graduate student, MD Anaesthesiology |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
Room no. 1, Ladies Postgraduate Hostel, Kidwai Memorial Institute of Oncology, Dr. M H Marigowda Road, Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
09845131337 |
| Fax |
|
| Email |
mohandas22namita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Kidwai Memorial Institute of Oncology
Dr. M H Marigowda Road, Hombegowda Nagar, Lakkasandra, Bangalore 560029 |
|
|
Primary Sponsor
|
| Name |
Namita Mohandas |
| Address |
Kidwai Memorial Institute of Oncology |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Namita Mohandas |
Kidwai Memorial Institute of Oncology |
Major OT Complex, Department of Anesthesiology
Bangalore
KARNATAKA |
09845131337
mohandas22namita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (2) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (3) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage, (4) ICD-10 Condition: C43-C44||Melanoma and other malignant neoplasms of skin, (5) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (6) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (7) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, (8) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (9) ICD-10 Condition: D3A-D3A||Benign neuroendocrine tumors, (10) ICD-10 Condition: D37-D48||Neoplasms of uncertain behavior, polycythemia vera and myelodysplastic syndromes, (11) ICD-10 Condition: D00-D09||In situ neoplasms, (12) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, (13) ICD-10 Condition: C7B-C7B||Secondary neuroendocrine tumors, (14) ICD-10 Condition: C7A-C7A||Malignant neuroendocrine tumors, (15) ICD-10 Condition: C76-C80||Malignant neoplasms of ill-defined, other secondary and unspecified sites, (16) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (17) ICD-10 Condition: C69-C72||Malignant neoplasms of eye, brain and other parts of central nervous system, (18) ICD-10 Condition: D10-D36||Benign neoplasms, except benign neuroendocrine tumors, (19) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (20) ICD-10 Condition: D49-D49||Neoplasms of unspecified behavior, (21) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA status 1 and 2
Patients consenting for the study |
|
| ExclusionCriteria |
| Details |
1. Patients with any feature of difficult
airway such as maxillofacial anomalies
2. Patients having restricted neck movements
3. Obese patients
(Body mass index [BMI] >40 kg/m2)
4. Patients with limited mouth opening
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Looking for any difficulty encountered during intubation. |
At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adjuncts used to overcome difficulty in intubation. |
After initial attempts of intubation |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
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)
|
31/10/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway assessment is an essential aspect of preanesthetic assessment. Presently, prediction of difficult airway is based on clinical assessment of airway. Difficult tracheal intubation is associated with serious morbidity and mortality and cannot be always predicted based on preoperative airway assessment using conventional clinical predictors. Despite the use of various clinical parameters, the diagnostic accuracy of a preanesthetic airway assessment in predicting difficult intubation is very low. There is a search for non-invasive and more accurate tools for airway assessment to overcome the above limitations of clinical airway assessment tests. Portable, non-invasive and point of care characteristics of ultrasonography can aid in airway assessment and prediction of difficult laryngoscopy. Ultrasound has been evolving as a useful device for airway assessment. The present study will be conducted to assess the usefulness of various sonographic airway parameters in predicting difficult laryngoscopy. |