| CTRI Number |
CTRI/2019/08/020603 [Registered on: 07/08/2019] Trial Registered Prospectively |
| Last Modified On: |
06/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to assess difficulty in securing an airway by measuring distances in neck, before surgery |
|
Scientific Title of Study
|
Prediction of difficult airway by comparision of Mallampatti test with acromioaxillarysuprasternal notch index(AASI) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harivart Kaushik |
| Designation |
Resident. Anaesthesia |
| Affiliation |
B. J. Medical College, Civil HospitalL, Ahmedabad |
| Address |
F3, Department of Anesthesia, Civil Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
8460125099 |
| Fax |
|
| Email |
Harivartkaushik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor |
| Affiliation |
B. J. Medical College, Civil HospitalL, Ahmedabad |
| Address |
F3, Department of Anesthesia, Civil Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor |
| Affiliation |
B. J. Medical College, Civil HospitalL, Ahmedabad |
| Address |
F3, Department of Anesthesia, Civil Hospital, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Health and family welfare department, Government of gujarat, Gandhinagar, Gujarat |
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
7th floor, Health and family welfare department, Sachivalay, Gandhinagar |
| 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 Harivart Kaushik |
Civil hospital, Ahmedabad, Gujarat, India |
F1 & F3, Orthopaedic & Main surgical Operation Theatre
Ahmadabad
GUJARAT |
8460125099
Harivartkaushik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, B. J. Medical College & Civil Hospital, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Acromioaxillarysuprasternal (AASI) notch index compared with mallampatti grading to predict difficult airway |
Measusing AASI index and mallampatti grading will be done before anesthesia to assess difficult airway. At the time of intubation, direct laryngoscopic view gading with cormack lahane test to predict difficult visualisation of larynx |
| Intervention |
Three test done to predict difficult airway. First measurement of distances in the neck, second grading as per visualization of intraoral structues and third grading of laryngoscopic view
|
By measuring different distances in the neck, acromioaxillarysuprasternal notch index measured. Mallampatti grading noted as per visualization of intraoral structures. Cormack and lahane grading done as per laryngoscopic view. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I - III, Either gender, Surgical procedures – general surgery, orthopaedic surgery |
|
| ExclusionCriteria |
| Details |
obvious anatomical abnormalit, upper airway abnormality (e.g. maxillofacial tumor, or fracture), Anticipated difficult airway, restricted mouth opening, Recent head and neck surgery, ASA Class IV and IV |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictive validity of new index called the acromioaxillosuprasternal notch index (AASI) and compare it with a standard test mallampati test (MMP) for assessing difficult laryngoscopic view |
We will measure aasi and modified mallampatti test in preoperative area and will compare it with cormack lahange grading which will be done after seeing vocal cord after laryngoscopy |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Intubation difficulties, intubation attempt, failed intubation, hemodynamic parameters, complications |
Staring of induction of anesthesia to 15 minutes after intubation of trachea. |
|
|
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)
|
30/07/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Mintaining
a patent airway following the induction of general anesthesia is undeniably the
most imperative concern for an anesthesiologist. The incidence of difficult
laryngoscopy or tracheal intubation was reported to be in the range of
0.1to20.2%. Unanticipated difficult intubation can lead to difficult or lack of
ventilation in anesthetized patients and can cause morbidity or mortality. Prediction
of difficult intubation in preoperative evaluation includes test based on anatomical
landmarks such as modified Mallampati test (MMP), interincisive distance,
thyromental distance (TMD), sternomental distance, upper lip bite test, and
hyomental distance. All tests nave different sensitivities and specificities. Experienced
anesthesiologist had observed difficult visualization of larynx (DVL) in
individuals whose neck was situated deep in the chest (i.e. with a sloping
clavicle). Test based on the surface anatomy of the upper chest - measuring
acromioaxillary distance above the line drawn from supra-sternal notch might be
used as an indicator to predict difficult airway. This,
study is designed to compare simple, cost effective acromioaxillosuprasternal
notch index (a new test) with modified mallampati test in predicting difficult
visualization of larynx |