| CTRI Number |
CTRI/2024/04/066282 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of airway assessment with preoperative ultrasonography and conventional larygoscopy in adult patients |
|
Scientific Title of Study
|
Correlation between preoperative Ultrasonographic airway assessment and Laryngoscopic view in adult patients: 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 |
Yerraboina madhavi |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
Department of Anesthesiology, Operation Theatre Complex, room no 200, 2nd floor, IP block, Government General Hospital, Kadapa, YSR Kadapa dt.
Department of Anesthesiology, Operation Theatre Complex, room no 200, 2nd floor, IP block, Government General Hospital, Kadapa, YSR Kadapa dt.
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
09966434292 |
| Fax |
|
| Email |
drmadhaviy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yerraboina madhavi |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
Department of Anesthesiology, Operation Theatre Complex, room no 200, 2nd floor, IP block, Government General Hospital, Kadapa, YSR Kadapa dt.
Department of Anesthesiology, Operation Theatre Complex, room no 200, IP block, Government General Hospital,Kadapa, YSR Kadapa dt.
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
09966434292 |
| Fax |
|
| Email |
drmadhaviy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yerraboina madhavi |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
Department of Anesthesiology, operation theatre complex, room no 200, 2nd floor, Government general hospital, Kadapa, YSR Kadapa dt.
Department of Anesthesiology, operation theatre complex, room no 200, 2nd floor, Government general hospital, Kadapa, YSR Kadapa dt.
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
09966434292 |
| Fax |
|
| Email |
drmadhaviy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department OF Anesthesiology, Government medical college, kadapa |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Chiruvella |
| Address |
Department of Anesthesiology, Government medical college, kadapa |
| Type of Sponsor |
Government 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 Y Madhavi |
Government general hospital kadapa |
Department of Anesthesiolgy, OT Complex, room no 200,2nd floor, IP building, Government general hospital, Puttlampalli, Kadapa. PIN 516002
Cuddapah
ANDHRA PRADESH |
09966434292
drmadhaviy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government medical college, kadapa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II/III
Patients undergoing elective surgeries in between April 2024 to June 2024 |
|
| ExclusionCriteria |
| Details |
Pregnancy
BMI more than 35
Cervical tumors
Goiter
History of cervical radiation therapy
Maxillo facial or cervical abnormalities
Patient refusal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate preopertive Ultrasonographic airway assessment of skin to hyoid distance, skin to epiglottis and Laryngoscopic view in adult patients |
Baseline and during intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check for number of intubation attempts, time for intubation, use of any alternate method for intubation |
staring time to end time of intubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Predicting difficult laryngoscopy by evaluation of airway is very important in anaesthesia practice.there are several clinical predictors for assesment of difficult airway. Ultrasonography has evolved as a simple, non invasive , portable and rapidly performed technique for airway assessment. The main advantage of Ultrasound in anaesthesia seems to be related to its predictive power for difficult airway. The present study is being done with the aim of finding some correlation between preoperative sonographic airway assessment of skin to hyoid bone distance, skin to epiglottis distance and the Cormack–Lehane (CL) grade at laryngoscopic view.This is a prospective observational study. After attaining approval from the institute ethics committee, and obtaining informed written consents, 50 patients of American Society of Anaesthesiologists (ASA) physical status I and II undergoing elective surgeries requiring general anaesthesia with endotracheal intubation were included in the study. Patients with deformity of face and neck, history of surgery or trauma of face, neck, larynx, pharynx and epiglottis, past history of difficult intubation, and those who are edentulous were excluded. Patients were in supine position with the head in the “sniffing†position and distance from the skin to the hyoid bone, skin to epiglottis will be measured using linear probe in transverse plane. The results will be correlated with Cormack- Lehane grading observed.
|