| CTRI Number |
CTRI/2018/07/014786 [Registered on: 10/07/2018] Trial Registered Prospectively |
| Last Modified On: |
17/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the role of upper airway ultrasound in predicting any difficulty, that may occur while inserting tracheal tube into airway |
|
Scientific Title of Study
|
A prospective observational study to determine the utility of upper airway ultrasonography in predicting difficult intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishabh |
| Designation |
Post-graduate student |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anesthesiology,
AIIMS Rishikesh,
Virbhadra Road,
Rishikesh
Dehradun
UTTARANCHAL
249204
India |
| Phone |
8130449525 |
| Fax |
|
| Email |
agarwalrishabh66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Jain |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anesthesiology,
AIIMS Rishikesh,
Virbhadra Road,
Rishikesh
Dehradun
UTTARANCHAL
249204
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Jain |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Anesthesiology,
AIIMS Rishikesh,
Virbhadra Road,
Rishikesh
Dehradun
UTTARANCHAL
249204
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology AIIMS Rishikesh |
| Address |
Virbhadra Road, Rishikesh, Uttarakhand |
| 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 |
| Rishabh |
All India Institute of Medical Sciences Rishikesh |
Operation Theatre Complex,Department of Anaesthesiology,Block C,Third floor
Dehradun
UTTARANCHAL |
8130449525
agarwalrishabh66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing general anaesthesia for any surgery requiring tracheal intubation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound examination of upper airway followed by tracheal intubation |
Patients will undergo ultrasonographic examination of upper airway in pre-operative room. For sublingual ultrasonography, in a sitting, neutral position, a high frequency curved array probe will be first covered with a sterile probe cover and patients will be told to take the ultrasound probe, orient it vertically and place it under the tongue. They will be instructed to advance it straight back as far as comfortable. The investigator will then ensure that the image is taken with the probe oriented perpendicular to the face. The obtained image will be reviewed and noted whether or not he could see the hyoid bone in the image. For submandibular ultrasonography, in a supine position with the neck extended, patients will be asked to keep their mouth closed and to place the tongue tip slightly touching the incisors, with the tongue relaxed and with no phonation. A curved probe (Frequency Range : 2 – 5 MHz ) will be placed under the chin in the median sagittal plane and will be adjusted to obtain the entire tongue outline clearly on the screen. This image will be frozen. The maximal vertical dimension from the tongue surface to the submental skin will be measured and defined as the tongue thickness. In the same position with the transducer placed after the 90 degree rotation, the image will be frozen and the anterior neck soft tissue thickness will be measured from the skin to the hyoid bone and from the skin to thyrohyoid membrane. Now the patients will be transported to operating room and general anaesthesia will be induced followed by endotracheal intubation. External laryngeal pressure or manipulation will be permitted to improve the view of the glottis. Difficult intubation is defined as an insertion of the tracheal tube using conventional laryngoscopy that required more than two attempts, lasted 10 min, or required an alternative technique. The end point of the study will be tracheal intubation, and any difficulty during intubation recorded. On this basis, patients will be categorized into two groups: difficult intubation or easy Intubation. Ultrasound based parameters of respective patients will be compared among the groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing general anaesthesia requiring tracheal intubation with American Society of Anesthesiologists class I or II or III |
|
| ExclusionCriteria |
| Details |
Deviation in study protocol
Upper airway anatomical deformity, trauma, or tumour
Identified difficult airway during preanesthetic checkup that required awake tracheal intubation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Upper airway ultrasonography based parameters including visibility of hyoid, thickness of tongue, anterior neck soft tissue thickness from the skin to hyoid bone and anterior neck soft tissue thickness from the skin to thyrohyoid membrane. Any difficulty during intubation |
Ultrasound based parameters in the preoperative room and difficulty during intubation after induction of general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Validity of models combinining various ultrasonography based parameters measured as primary outcome in predicting difficult intubation |
During data interpretation |
|
|
Target Sample Size
|
Total Sample Size="1030"
Sample Size from India="1030"
Final Enrollment numbers achieved (Total)= "1030"
Final Enrollment numbers achieved (India)="1030" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2018 |
| Date of Study Completion (India) |
31/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2019 |
|
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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational trial to determine the utility of upper airway ultrasonography in predicting difficult intubation by comparing the ultrasonography derived parameters among difficult and easy intubation groups. The study will be conducted in AIIMS Rishikesh on 1030 subjects. The primary outcome will be to get the effectiveness of upper airway ultrasonography based parameters in predicting difficult intubation. The secondary outcome will be to get the validity of the models of combined ultrasonography based parameters in predicting difficult intubation |