| CTRI Number |
CTRI/2019/11/021880 [Registered on: 05/11/2019] Trial Registered Prospectively |
| Last Modified On: |
11/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
a study to determine if ultrasound is helpful in predicting difficulty in intubating pediatric patients |
|
Scientific Title of Study
|
Use of ultrasound as a tool to predict difficult intubation in pediatric 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 Anil Agarwal |
| Designation |
HOD Anesthesiology |
| Affiliation |
Sanjay gandhi post graduate institute of medical sciences |
| Address |
Sanjay gandhi post graduate institute of medical sciences
Raebareilly road
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904589 |
| Fax |
|
| Email |
anil_sgpgi@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anil Agarwal |
| Designation |
HOD Anesthesiology |
| Affiliation |
Sanjay gandhi post graduate institute of medical sciences |
| Address |
Sanjay gandhi post graduate institute of medical sciences
Raebareilly road
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904589 |
| Fax |
|
| Email |
anil_sgpgi@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shruti Pandey |
| Designation |
Junior Resident Anesthesiology |
| Affiliation |
Sanjay gandhi post graduate institute of medical sciences |
| Address |
Sanjay gandhi post graduate institute of medical sciences
Raebareilly road
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9450384490 |
| Fax |
|
| Email |
shruti.sgpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raibareli Rd, Lucknow, Uttar Pradesh 226014 |
|
|
Primary Sponsor
|
| Name |
Dr Anil Agarwal |
| Address |
Sanjay Gandhi Post Graduate Institute of Medical Science, Raibareli Rd, Lucknow, Uttar Pradesh 226014 |
| Type of Sponsor |
Other [HOD Department of Anesthesia] |
|
|
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 Anil Agarwal |
SGPGI |
Sanjay gandhi post graduate institute of medical sciences
Raebareilly road
Lucknow UTTAR PRADESH |
8004904589
anil_sgpgi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SGPGI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the specified age group undergoing elective surgery |
|
| ExclusionCriteria |
| Details |
Lack of parents’ consent Child not co-operative
Patients with head or neck anomalies
Syndromic patients
Patients undergoing emergency surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the utility of ultrasonographic measurements of tongue width, tongue thickness, tonsil size, hyo-mental distance and thyrohyoid distance of pediatric patients in predicting difficult intubation |
Night before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To determine the predictive value of these ultrasonographic measurements in determination of optimal endotracheal tube size. |
At the time of induction of surgery |
| 2. To examine the association between these ultrasonographic measurements and airway clinical screening tests (interincisor gap, Mallampati grade and thyromental distance) |
Night before surgery |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2019 |
| Date of Study Completion (India) |
10/09/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
PRIMARY
OBJECTIVE:To determine the utility of ultrasonographic
measurements of tongue width, tongue thickness, tonsil size, hyo-mental distance and
thyrohyoid distance of pediatric patients in predicting difficult intubation.
SECONDARY OBJECTIVE:
1.
To determine the predictive value
of these ultrasonographic measurements in determination of optimal endotracheal
tube size.
2.
To examine the association between
these ultrasonographic measurements and airway clinical screening tests
(interincisor gap, Mallampati grade and thyromental distance).
Examination of the
airway is the most essential component of such preoperative evaluation, from an
anaesthesiologist’s point of view. Difficulties in airway management largely contribute to increased mortality and morbidity for the patient. Classically employed methods for airway examination
include measurement of inter-incisor distance and thyromental distance,
estimation of Mallampati grade and assessment of the degree of neck flexion and
extension. These tests are of limited use in evaluation of the pediatric
airway owing to difference in anatomy of the pediatric airway when compared to
that of an adult and, failure to obtain a child’s cooperation in performing
these tests. A study done by Kopp et
al showed that Mallampati score is a poor predictor of difficult laryngoscopy
in paediatric patients.
Though multiple
parameters exist for examination of the adult airway, there is limited data on
methods to assess the pediatric airway. Thus, relevant, simple and non-invasive
methods to evaluate pediatric airway are required to accurately assess the
patient’s airway pre-operatively and decrease the occurrence of unanticipated
difficult airway intraoperatively.
|