CTRI Number |
CTRI/2017/09/009614 [Registered on: 04/09/2017] Trial Registered Retrospectively |
Last Modified On: |
03/09/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Single Arm Study |
Public Title of Study
|
a study to determine the usefulness of ultrasonography to measure neck tissue to help us predict difficulty in intubation. |
Scientific Title of Study
|
Prediction of difficult laryngoscopy & intubation by anterior neck tissue quantification using ultrasound |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Chandni Sinha |
Designation |
Assistant Professor, Department of Anaesthesia |
Affiliation |
AIIMS,Patna |
Address |
Faculty room, OT complex, 3rd floor, Ayush PMR, AIIMS,Patna
Patna BIHAR 801505 India |
Phone |
06122451205 |
Fax |
|
Email |
chandni.doc@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Chandni Sinha |
Designation |
Assistant Professor, Department of Anaesthesia, Department of Anaesthesia |
Affiliation |
AIIMS,Patna |
Address |
Faculty room, OT Complex, 3rd floor, Ayush PMR Building, AIIMS,Patna AIIMS,Patna Patna BIHAR 801505 India |
Phone |
06122451205 |
Fax |
|
Email |
chandni.doc@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Chandni Sinha |
Designation |
Assistant Professor, Department of Anaesthesia |
Affiliation |
AIIMS,Patna |
Address |
Faculty room, OT Complex, 3rd floor, Ayush PMR Building, AIIMS,Patna
Patna BIHAR 801505 India |
Phone |
06122451205 |
Fax |
|
Email |
chandni.doc@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS Patna |
Address |
Department of Anaesthesia, Faculty Room, OT complex, 3rd floor, Ayush PMR Building,AIIMS, Patna |
Type of Sponsor |
Research institution and hospital |
|
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 Chandni Sinha |
AIIMS,Patna |
OT Complex, 3rd floor, Ayush PMR Building, AIIMS,Patna Patna BIHAR |
06122451205
chandni.doc@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
AIIMS Patna IEC,(Human Studies) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
ASA I/II, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
laryngoscopic examination |
laryngoscopy would be done at the time of intubation |
Intervention |
Ultrasound examination |
ultrasound assessment of the airway would be done at the time of preanesthetic assessment( preoperatively)
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA I or II patients undergoing elective surgeries under general anaesthesia with endotracheal intubation |
|
ExclusionCriteria |
Details |
Patients with history of airway trauma
Patients with anterior neck masses/ swellings
Patients with limited mouth opening/ neck extention due to various reasons
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
any correlation between anterior neck tissue measurement at the level of vocal cords and Cormack Lahane classification on laryngoscopy |
at the time of laryngoscopy |
|
Secondary Outcome
|
Outcome |
TimePoints |
any correlation between anterior neck tissue maesurement at the level of suprasternal notch and cormack lahane classification on laryngoscopy. |
at the time of laryngoscopy |
correlation between anterior neck tissue measurement at the level of thyroid isthmus and cormack lahane classification |
at the time of laryngoscopy |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
20/04/2016 |
Date of Study Completion (India) |
03/11/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Unanticipated difficult intubation remains a primary concern for
anesthesiologists as failure to secure
the airway can cause anesthesia-related life-threatening morbidity and
mortality. Difficult laryngoscopy & intubation rate is still as high as
1.5-13% instead of various screening tools.
Ultrasound is a non-invasive, repeatable, portable device which provides
improved visualization of airway structure. Hence we aim to study the role of
airway ultrasound in predicting difficult laryngoscopy by measuring anterior
neck soft tissue thickness and comparing with clinical parameters &
Cormack-Lehane grading. We will
sonographically examine the neck of the patient preoperatively and will
correlate it with laryngoscopic examination.
Ultrasound measurements will be performed with the patient supine
and the head and neck in neutral position by the primary investigator. The
thicknesses of anterior neck soft tissue at vocal cord, thyroid isthmus, and
supra-sternal notch levels were obtained transversely across the anterior
surface of the neck with a 13–6 MHz linear array ultrasound probe attached to a
SonoSite machine (SonoSite Inc., Bothell, WA, USA). At vocal cord level (Zone
I), the minimal distance from the thyroid cartilage to skin surface & 15mm
to the left & right will be measured. At thyroid isthmus level (Zone II),
the distance from skin to trachea & 15mm to the left & right was
measured. At supra-sternal notch level (Zone III), the minimal distance from skin
to trachea & 15mm to the left & right will be obtained. In the
operation theatre, laryngoscopy will be
done and Cormack lahane grading will be noted. The results obtained will be statistically
analyzed. Comparison analysis will be performed using the t-test for continuous
variables and chi-square or Fisher exact tests, as appropriate, for
non-continuous variables. Correlation analysis will be performed using the
Pearson test & p value
<0.05 will be considered as significant. |