| CTRI Number |
CTRI/2022/11/047141 [Registered on: 09/11/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to determine if ultrasound is effective in predetermining difficult laryngoscopy and intubation in ICU patients |
|
Scientific Title of Study
|
Evaluation of point of care ultrasound of airway to predict difficult laryngoscopy and intubation in intensive care unit 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 Shreyasi Mallick |
| Designation |
Postgraduate Trainee |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anesthesiology
3rd floor
PBMH
KIMS
KIIT University
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9620893003 |
| Fax |
|
| Email |
shreyasimallick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saswati Das |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anesthesiology
3rd floor
PBMH
KIMS
KIIT University
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9910760328 |
| Fax |
|
| Email |
das.saswati12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saswati Das |
| Designation |
Associate Professor |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anesthesiology
3rd floor
PBMH
KIMS
KIIT University
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9910760328 |
| Fax |
|
| Email |
das.saswati12@gmail.com |
|
|
Source of Monetary or Material Support
|
| PBMH
KIMS
KIIT University |
|
|
Primary Sponsor
|
| Name |
Dr Shreyasi Mallick |
| Address |
Department of Anesthesiology
3rd floor
PBMH
KIMS
KIIT University
Bhubaneswar- 751024
|
| Type of Sponsor |
Other [Self funding] |
|
|
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 SHREYASI MALLICK |
PBMH |
Department of Critical care medicine
5TH FLOOR
Khordha
ORISSA |
9620893003
shreyasimallick@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Consenting patients who are intubated in ICU |
|
| ExclusionCriteria |
| Details |
1. Patients requiring crash intubation
2. Pregnant patients
3. Patients having open injuries on the neck
4. Patients with cervical spine injuries, maxillofacial fractures, and tumors.
5. Morbidly obese patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cormack- lehane grading
|
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thyromental height (TMH) and Hyomental distance ratio (HMD-R) |
baseline |
|
|
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)
|
15/11/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tracheal intubation (TI) is integral to the care provided to critically ill patients. Unfortunately, this procedure is associated with a high incidence of adverse events (45.2%). Difficult intubation scenario is frequently encountered in the Intensive Care Unit (ICU) with the incidence ranging between 8% and 12%. Recognizing a potentially difficult airway is an important skill as it allows for optimal preparation, equipment selection, and participation of experienced personnel. The aim of this study is to evaluate the role of USG in the assessment of the airway and to determine whether USG has the potential to serve as an effective, non-invasive method for the diagnosis of difficult intubation in ICU patients. |