| CTRI Number |
CTRI/2022/04/041742 [Registered on: 08/04/2022] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare airway ultrasound and clinical airway assessment of obese patients preoperatively to help with endotracheal intubation. |
|
Scientific Title of Study
|
To evaluate the accuracy and efficacy of ultrasound guided airway assessment in comparison to clinical parameters in anticipating difficult intubation in patients with obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tamanna Yadav |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Markandeshwar Institure of Medical Sciences and Research |
| Address |
Department of Anesthesiology, MMIMSR, Mullana, Ambala
Ambala
HARYANA
133297
India |
| Phone |
9971262211 |
| Fax |
|
| Email |
drtamannayadav.90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Gupta |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of medical Sciences and Research |
| Address |
Department of Anesthesiology, Maharishi Markandeshwar Institute of medical Sciences and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9779134395 |
| Fax |
|
| Email |
guptaritz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Gupta |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of medical Sciences and Research |
| Address |
Department of Anesthesiology, Maharishi Markandeshwar Institute of medical Sciences and Research, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9779134395 |
| Fax |
|
| Email |
guptaritz@gmail.com |
|
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Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of medical Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Maharishi Markandeshwar Institute of medical Sciences and Research, Mullana, Ambala |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tamanna Yadav |
MMIMSR, Mullana , Ambala |
Department of Anesthesiology
Ambala
HARYANA |
9971262211
drtamannayadav.90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethical committee, MMIMSR, Mullana, Ambala |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I, II, III
Patients with BMI > 30
Age between 18-65 years
Posted for elective surgery or procedure |
|
| ExclusionCriteria |
| Details |
Patient Refusal
ASA grade IV
Patients with cervical spine pathology
Neck Masses
Patients with Tracheostomy
Patients scheduled for fiberoptic intubation.
Emergency cases
Anasarca
Patients who require rapid sequence induction
Facial fractures |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of ultrasound in predicting difficult laryngoscopy in obese patients. |
The time of assessment will be preoperative ultrasound of airway. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the airway ultrasound findings with Cormack Lehane grading in anticipating difficult laryngoscopy in obese patients. |
To be evaluated at the time of direct laryngoscopy. |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/04/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/06/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Airway
assessment is an important aspect of pre-anesthetic check-up. Presently every
and all predictions of difficult airway is based majorly on clinical assessment
of the airway. Airway examination tests like Modified- Mallamapati grading, ,
thyro-mental distance, inter-incisor gap, neck mobility and sterno-mental
distance are used together
to overcome their finite sensitivity and specificity to accurately assess
difficult laryngoscopies and intubations.
Even after using multiple clinical screening tests a significant amount of
cases present with unanticipated difficult laryngoscopy. The
search for a better, cheaper, sensitive, specific and non-invasive tools for
airway assessment to avoid the above restrictions of clinical airway
examination tests is the need of the hour especially in patients where clinical
assessment is sub-par like those with obesity i.e a BMI more than 30 (obese patients),
short bulky neck, short stature, skeletal deformities to name a few. Portable
non-invasive assessment with USG in obese patients can aid in accurate assessment
of airway and eliminate the risk of unanticipated difficult bag and mask
ventilation as well as intubation thus lowering the risk of CVCI incidences and
help better prepare the plan of anesthesia. Thus, here we will be conducting an observational study to determine whether ultrasound guided airway assessment is a better predictor of difficult airway as compared to clinical parameters in patients with BMI more than 30.
|