| CTRI Number |
CTRI/2024/08/072557 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
AIRWAY ASSESSMENT USING CLINICAL PARAMETERS AND ULTRASONOGRAPHIC PARAMETERS FOR PREDICTING DIFFICULT AIRWAY |
|
Scientific Title of Study
|
Evaluation of Accuracy of Ultrasound guided airway assessment and clinical parameters in prediction of difficult airway - A prospective analytical 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 |
Dr Amrutha D |
| Designation |
Postgraduate |
| Affiliation |
Sri Muthukumaran Medical College hospital and Research Institute |
| Address |
Department of Anaesthesiology - 5th floor
Sri Muthukumaran Medical College hospital and Research Institute
Kancheepuram
Tamilnadu
600069
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
7904660837 |
| Fax |
|
| Email |
damrutha1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Navya C N |
| Designation |
Professor |
| Affiliation |
Sri Muthukumaran Medical College hospital and Research Institute |
| Address |
Department of Anaesthesiology - 5th floor
Sri Muthukumaran Medical College hospital and Research Institute
Kancheepuram
Tamilnadu
600069
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
9791793965 |
| Fax |
|
| Email |
drcn.navya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha D |
| Designation |
Postgraduate |
| Affiliation |
Sri Muthukumaran Medical College hospital and Research Institute |
| Address |
Department of Anaesthesiology - 5th floor
Sri Muthukumaran Medical College hospital and Research Institute
Kancheepuram
Tamilnadu
600069
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
7904660837 |
| Fax |
|
| Email |
damrutha1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology - 5th floor
Sri Muthukumaran Medical College hospital and Research Institute
Kancheepuram
Tamilnadu
600069 |
|
|
Primary Sponsor
|
| Name |
DR Amrutha D |
| Address |
Department of Anaesthesiology - 5th floor
Sri Muthukumaran Medical College hospital and Research Institute
Kancheepuram
Tamilnadu
600069 |
| 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 |
| Dr Amrutha D |
Sri Muthukumaran Medical College hospital and Research Institute Kancheepuram Tamilnadu 600069 |
Department of Anaesthesiology - 5th floor
Sri Muthukumaran Medical College hospital and Research Institute
Kancheepuram
Tamilnadu
600069
Kancheepuram
TAMIL NADU |
7904660837
damrutha1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z04||Encounter for examination and observation for other reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients 18- 65yrs requiring general anaesthesia with ET intubation for elective surgeries
All gender
Patients who have given valid informed consent
Upper lip bite test less than II
Interincisor gap more than 3 centimetres
Patients with adequate neck movements
|
|
| ExclusionCriteria |
| Details |
Any patient planned for awake fiberoptic intubation
Edentulous patients/dentures.
Patients with facio maxillary trauma , facial anomalies
Patients with restricted neck movements, neck swellings
Obstetric patients
Emergency surgeries
Cervical spine injury/pathology
Rapid sequence intubation
H/O difficult airway in previous surgery |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Airway assessment using clinical parameters and ultrasonographic parameters |
Preoperatively in the pre assessment clinic on the day prior to surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the prevalance of difficult intubation
To find difficult mask ventilation score & intubation difficulty scale during induction on the day of surgery |
Intraoperatively on the day of surgery during premedication & induction |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
28/08/2024 |
| 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="1"
Months="0"
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
|
This study is a prospective analytical observational study for evaluating the accuracy of ultrasound guided airway assessment and clinical parameters in prediction of difficult airway. Routine clinical parameters like h/o snoring, MMPC, ULBT, TMD(CMS), NC (CMS), HMD(CMS),SMD(CMS) will be measured. ultrasonographic measurements like ANS - VC, STB + TT, SED, SHD will be measured. On the day of surgery,
theatre will be kept ready. Patient will be connected to standard monitors.18G
IV cannula will be secured. After preoxygenation and
premedication , all the patients will be induced with inj.propofol – 2mg/kg,
post check ventilation, inj.vecuronium -0.1mg/kg will be administered. Patient
will be given sniffing position ,direct laryngoscopy will be performed using
appropriate sized Macintosh blade and intubated
with endotracheal tube by the same Anaesthesiologist. •
Difficult mask
ventilation and intubation difficulty scale (IDS) will be noted by the
investigator.
•
Anaesthesia will be
maintained as per standard procedures. In case of unanticipated Cannot
Ventilate / Cannot Intubate, difficult airway algorithm will be followed. With the help of the above collected data i.e,
ultrasonographic airway assessment and clinical parameters ,the accuracy of the
same and their validity in predicting the difficult airway will be assessed
,which may help for proper planning and management of safe securing of airway. |