| CTRI Number |
CTRI/2024/02/062651 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Study to compare clinical method of airway assessment with ultrasonographic method of airway assesment to predict difficult laryngoscopy in patients requiring general anesthesia. |
|
Scientific Title of Study
|
A PROSPECTIVE OBSERVATIONAL STUDY TO COMPARE CLINICAL CONVENTIONAL METHOD OF AIRWAY ASSESSMENT WITH ULTRASONOGRAPHIC METHOD OF AIRWAY ASSESSMENT TO PREDICT DIFFICULT LARYNGOSCOPY IN PATIENTS REQUIRING GENERAL ANESTHESIA |
| 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 Gamit Meghnaben Ravindrabhai |
| Designation |
Second Year Resident in Anaesthesia |
| Affiliation |
Government Medical College. New Civil Hospital. Surat. |
| Address |
Government Medical College. New Civil Hospital. Surat
Surat
GUJARAT
395001
India |
| Phone |
7573800410 |
| Fax |
|
| Email |
meghnagamit3008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunaina N Patel |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College. New Civil Hospital. Surat. |
| Address |
Government Medical College. New Civil Hospital. Surat
Surat
GUJARAT
395001
India |
| Phone |
9825143013 |
| Fax |
|
| Email |
patel_sunaina@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunaina N Patel |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College. New Civil Hospital. Surat. |
| Address |
Government Medical College. New Civil Hospital. Surat
Surat
GUJARAT
395001
India |
| Phone |
9825143013 |
| Fax |
|
| Email |
patel_sunaina@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College. New Civil Hospital.
Majura Gate, Surat. |
|
|
Primary Sponsor
|
| Name |
Government Medical College. New Civil Hospital. Surat |
| Address |
Government Medical College, Majura Gate, Surat. |
| 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 Gamit Meghnaben Ravindrabhai |
New Civil Hospital. Surat |
Department of Anaesthesia.New Civil Hospital.
Majura Gate, Surat.
Surat
GUJARAT |
7573800410
meghnagamit3008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HREC, Government Medical College,. Surat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for planned surgery under general anesthesia with orotracheal intubation.
Patients belonging to ASA grade I, II or III.
Patients in between the age group of 18-60 years. |
|
| ExclusionCriteria |
| Details |
Pregnant Female, Patients with previous history of difficult intubation, patient with cervical spine injury, patient with gross anatomical abnormalities of throat, oral cavity, maxillofacial, face. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary:
1) clinical parameters
• Body mass index
• Neck circumferance
• Inter incisior distances
• Sternomental distances
• Thyromental distances
• Modified mallampati classification
• History of snoring
2)Ultrasound parameters
• Distance of soft tissue at the level of vocal cord , hyoide bone at level of thyroid isthamus. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary:
Mask ventilation characteristics:
1)single handed or double handed
2) easy or difficult
3) any episode of desaturation
Intubation characteristics :
1) Attempts of intubations
2) External laryngeal maneuver given or not
3) Any adjuvants required for intubation |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/02/2024 |
| 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 Yet Recruiting |
| 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
|
A prospective observational study to compare clinical method of airway assessment with ultrasonographic method of airway assesment to predict difficult laryngoscopy in patients requiring general anesthesia. It is to assess the difficult while doing laryngoscopy. |