| CTRI Number |
CTRI/2017/11/010320 [Registered on: 01/11/2017] Trial Registered Prospectively |
| Last Modified On: |
10/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
pilot |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Is Ultrasound of neck a predictor of difficult airway management in obese patients? |
|
Scientific Title of Study
|
Ultrasound assessment of airway for prediction of difficult laryngoscopy in obese patients- a Prospective Observational Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjitha N |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no: 5011, Department of Anaesthesiology, Pain Medicine and Critical Care, Fifth floor,Teaching block, AIIMS, New delhi.
New Delhi
DELHI
110049
India |
| Phone |
9003800025 |
| Fax |
|
| Email |
ranjithaaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bikash Ranjan Ray |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no: 5011, Department of Anaesthesiology, Pain Medicine and Critical Care, Fifth floor,Teaching block, AIIMS, New delhi.
New Delhi
DELHI
110049
India |
| Phone |
9899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjitha N |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no: 5011, Department of Anaesthesiology, Pain Medicine and Critical Care, Fifth floor,Teaching block, AIIMS, New delhi.
New Delhi
DELHI
110049
India |
| Phone |
9003800025 |
| Fax |
|
| Email |
ranjithaaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi. Pin :110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Dekhi. Pin :110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ranjitha N |
All India Institue of Medical Sciences |
Department of Anaesthesiology, Pain Medicine and Critical Care, Ansari Nagar, New Delhi, Delhi 110029
New Delhi
DELHI |
9003800025
ranjithaaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Any patient of age between 18 to 75 years with BMI more than 30.0 kg/m2 who is undergoing surgery under general anaesthesia., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 to 75 years
2.BMI >30.0 kg/m2
3.Undergoing elective surgery requiring general anaesthesia |
|
| ExclusionCriteria |
| Details |
1.refusal to participate
2.upper airway pathology
3.cervical spine fractures
4.pregnant women
5.gross anatomic abnormalities
6.history of mandibular or neck surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation between the sonographic suprahyoid and infrahyoid measurement of airway, with difficult laryngoscopy in obese patients. |
end of 2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the correlation between the Sonographic measurements and Difficult Mask Ventilation in obese patients. |
End of 2 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/11/2017 |
| Date of Study Completion (India) |
31/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In general anaesthesia airway related problems continue to be the most common cause of morbidity and mortality. And in obese patients airway management becomes a prime importance. Ultrasound being a bed side tool, has an established role in airway management. The submandibultiar scanning and pretracheal soft tissue thickness has the potential for predicting difficult mask ventilation and laryngoscopy in obese patients. However there is paucity of data in literature using ultrasound for this purpose. Hence this study aims to determine the utility of ultrasound in predicting difficult laryngoscopy in obese patients. |