| CTRI Number |
CTRI/2022/12/048185 [Registered on: 16/12/2022] Trial Registered Prospectively |
| Last Modified On: |
15/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To see airway using ultrasound in obese patient and plan for better airway management. |
|
Scientific Title of Study
|
An observational study of ultrasound guided airway assessment for predicting difficult laryngoscopy in obese patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sruti |
| Designation |
Postgraduate student, Department of Anesthesia |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital |
| Address |
Department of Anaesthesiology, SDMCMSH, Manjushree Nagar, Sattur, Dharwad
Dharwad
KARNATAKA
570009
India |
| Phone |
9972304748 |
| Fax |
|
| Email |
srutismile@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Bhat |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of medical Sciences and hospital |
| Address |
Department of Anaesthesiology, SDMCMSH, Manjushree Nagar, Sattur,Dharwad
Department of Anaesthesiology, SDMCMSH, Manjushree Nagar, Sattur, Dharwad-570009
Dharwad
KARNATAKA
570009
India |
| Phone |
9740183281 |
| Fax |
|
| Email |
kakkodravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Bhat |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of medical Sciences and hospital |
| Address |
Department of Anaesthesiology, SDMCMSH, Manjushree Nagar, Sattur,Dharwad
Dharwad
KARNATAKA
570009
India |
| Phone |
9740183281 |
| Fax |
|
| Email |
kakkodravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital(SDMCMSH) Manjushree Nagar, Sattur, Dharwad-570009 |
|
|
Primary Sponsor
|
| Name |
SDMCMSH, MANJUSHREE NAGAR, SATTUR, DHARWAD |
| Address |
Department of Anaesthesiology, SDMCMSH, Manjushree Nagar, Sattur, Dharwad-570009 |
| Type of Sponsor |
Private 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 Sruti |
SDM College of Medical Sciences and Hospital, Dharwad |
Department of Anaesthesiology, Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital(SDMCMSH),Manjushree Nagar, Sattur, Dharwad-570009
Dharwad
KARNATAKA |
9972304748
srutismile@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMCMS&H/IEC:9:2021 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain etiology or emergency use, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation.
ASA I,II,III cases
Obese or over weight (BMI>25kg/m²) |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study.
Patients with any upper airway deformities, tumors, mandibular deformities.
Restricted mouth-opening
Patients who required supraglottic airway devices or nasal intubation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Using ultrasonography to assess airway to predict difficult laryngoscopy in obese. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Try to incorporated ultrasound in elective cases to assess airway difficulty in order to reduce airway trauma and plan management better. |
12months |
|
|
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)
|
19/12/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [srutismile@gmail.com].
- For how long will this data be available start date provided 15-11-2023 and end date provided 15-11-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Endotracheal intubation is one among the vital skills for anesthesiologist. Failure or delay to secure the airway can cause life-threatening morbidity and mortality, especially in the obese patients. Therefore, unanticipated difficult intubation remains a primary concern to anesthesiologist. Airway management plays a crucial role in anesthetic practice. Failure of airway management remains primary concern for anesthesiologist. There are various tests available for assessing difficult airway, but they have poor discriminative power when used alone as compared to a combination of tests. Modified Mallampati score, thyromental distance (TMD), sternomental (SM) distance, upper lip bite test are widely recognized methods for predicting difficult laryngoscopy. In patients with short neck, double chin (which makes neck extension limited), buck tooth difficult intubation is anticipated, also if patient is edentulous mask holding is difficult.Despite having many tests to assess airway, unanticipated difficult airway still remains a major concern. The unanticipated difficult airway can lead to cannot ventilate and cannot intubate situation. In such situations a more scientific approach to airway assessment and management becomes necessary. Most cases of unanticipated difficult intubation are managed satisfactorily, but problems with tracheal intubation could cause serious soft tissue damage and are the principal cause of hypoxemic brain damage and anesthetic death. So management of the difficult laryngoscopy and tracheal intubation must be planned well in advance for maintenance of oxygenation and to prevent airway trauma. The problem becomes more pronounced in case of obes patients. So using ultrasonography preoperatively helps assess the airway in obese and predict difficult laryngoscopy. Patients chosen for the study had BMI >25 kg/m². Using ultrasound we measure tongue thickness, skin to epiglottis distance, skin to vocal cords distance. Also we will time intubation duration and assess if and maneuver was done and any other instruments used.
|