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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 


 
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