| CTRI Number |
CTRI/2024/04/065758 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to evaluate the difficulty of direct laryngoscopy and intubation by measuring tongue thickness using ultrasound |
|
Scientific Title of Study
|
Evaluation of tongue thickness using ultrasound as a predictor of difficult direct laryngoscopy and intubation |
| 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. BHOOMIKA B S |
| Designation |
POST GRADUATE |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU - 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9448370345 |
| Fax |
|
| Email |
dr.bsbhoomika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M SALIM IQBAL |
| Designation |
PROFESSOR |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU- 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9964651079 |
| Fax |
|
| Email |
dr.salim_iqbal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR. BHOOMIKA B S |
| Designation |
POST GRADUATE |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU-560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9448370345 |
| Fax |
|
| Email |
dr.bsbhoomika@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
DRBHOOMIKA B S |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU- 560045, KARNATAKA |
| 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 BHOOMIKA B S |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
O T COMPLEX, DEPARTMENT OF ANAESTHESIOLOGY, K G HALLI, SHAMPURA MAIN ROAD, BENGALURU- 560045
Bangalore
KARNATAKA |
9448370345
dr.bsbhoomika@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: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.patients posted for elective surgeries needing general anesthesia
2.age more than 18 years of age
3. American society of anesthesiologists (ASA) class 1 and 2 patients |
|
| ExclusionCriteria |
| Details |
1. patients with maxillofacial deformities or fractures
2.patients with preoperatively anticipated difficult airway
3.anatomical deformity of neck or face region
4.modified anaesthetic procedure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and corelate the ultrasound assessment of tongue thickness pre operatively to predict difficult laryngoscopy with Cormack Lehane classification during direct laryngoscopy under general anaesthesia |
at the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To check for the number of attempts at intubation |
at the time of intubation |
| 2.To check if external pressure is applied to facilitate intubation or not |
at the time of intubation |
| 3.use of any adjuncts (gum elastic bougie) will be recorded |
at the time of intubation |
|
|
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)
|
06/05/2024 |
| 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="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
|
Airway management is an essential component of
clinical anesthesia and it involves maintenance of a patent airway to
facilitate gas exchange via mask ventilation or airway device. An important
aspect of airway management is to assess the patient’s airway to predict the
likelihood of ease or difficulty with bag mask ventilation or with laryngoscopy
and intubation, enabling the anesthesiologist to prepare for this challenging
clinical scenario. Unanticipated difficult airways are potentially
life threatening and remain a significant concern for clinicians managing the
airway. Airway associated complications are the most
common anaesthesia related adverse outcomes. Intubation failure is usually
attributed to difficult laryngoscopy. There have been no effective methods to predict
difficult airway accurately. Hence seeking a more accurate method is necessary
for anaesthesia. harm to the body. Ultrasound imaging techniques have
recently emerged as a novel, simple, portable, non-invasive tool helpful for
pre-operative airway assessment and management. Therefore, this study has been
designed to evaluate the predictive value of accurately measured tongue
thickness using ultrasonography for predicting difficult laryngoscopy and
difficult tracheal intubation. |