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CTRI Number  CTRI/2023/07/055874 [Registered on: 31/07/2023] Trial Registered Prospectively
Last Modified On: 24/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Using ultrasound scan to look for upper airway in children and to predict difficult upper airway tube placement and post operative airway obstruction. 
Scientific Title of Study   Sonographic Airway Assessment to predict difficult LMA placement and Anaesthesia induced upper airway obstruction in pediatric population. 
Trial Acronym  NOT APPLICABLE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRARSHAD AYUB  
Designation  Associate professor  
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 
Address  Room no 707 7th floor RPC centre AIIMS campus Ansari nagar New Delhi 110029

South
DELHI
110029
India 
Phone  9953542344  
Fax    
Email  drarshad2k1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRARSHAD AYUB  
Designation  Associate professor  
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 
Address  Room no 707 7th floor RPC centre AIIMS campus Ansari nagar New Delhi 110029

South
DELHI
110029
India 
Phone  9953542344  
Fax    
Email  drarshad2k1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr AMRUTH NARAYAN S 
Designation  Junior resident academic  
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 
Address  Room no 602 6th floor hostel 14 AIIMS campus Ansari nagar New Delhi 110029

South
DELHI
110029
India 
Phone  9182828029  
Fax    
Email  amruthsrinivasan18@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMRNT OF ANAESTHESIOLOGY PAIN AND CRITICAL CARE , AIIMS NEW DELHI, NEAR AUROBINDO MARG, ANSARI NAGAR. 110029 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  AIIMS campus Ansari nagar near Aurobindo marg New Delhi 110029 
Type of Sponsor  Government medical college 
 
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 Arshad Ayub   AIIMS NEW DELHI   DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE. ROOM- 1. AB 8 RECOVERY ROOM AIIMS NEW DELHI. 2. PREOPERATIVE ROOM OF RAJENDRA PRASAD CENTER AIIMS NEW DELHI
South
DELHI 		 9953542344

drarshad2k1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H260||Infantile and juvenile cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  a.Children of age group 1-10 years.
b.Both male and female children.
c.Children undergoing surgery under general anesthesia using SAD.
d.Parents or legal guardians giving consent. 
 
ExclusionCriteria 
Details  1.Parents or surrogates not giving consent.
2.Patients with oropharyngeal pathology.
3.Patients with risk of aspiration.
4.Airway anomalies or syndromes related with difficult airway.
5.Presence of active pulmonary disease Abbas poor chest complains.
6.Preoperative oxygen saturation at room air <95%
7.Tracheotomy  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Difficult Laryngeal Mask Airway Placement  Before the induction of anaesthesia to the patient in the pre operative room on the same day of the surgery .  
 
Secondary Outcome  
Outcome  TimePoints 
1.Assessment of Difficult Mask Ventilation.

2. Assessment of post operative airway obstruction. 		 1. In the operation theatre on the day of surgery.
2. After the surgery in the post operative room. 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   07/08/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Sonographic Airway Assessment to predict difficult LMA placement and Anaesthesia induced upper airway obstruction in pediatric population.


To assess the diagnostic accuracy of suprahyoid parameters (Tongue thickness, Tongue cross-sectional area, Tongue volume, Oral cavity height, Tongue thickness/oral cavity height. Hyomental distance ratio (HMD) 

PRIMARY OBJECTIVE

1.    Difficult SAD Airway ( Proseal LMA) insertion.

SECONDARY OBJECTIVES 

1.    Difficult mask ventilation (grading)

2.    Time for SAD insertion.

3.    No. of attempts

4.    Failure or success

5.    Grading of SAD insertion

6.    Maneuvers needed for SAD insertion

7.    Post-operative airway obstruction

8.    Trauma during insertion, Any adverse event (Desaturation, Bradycardia etc.)

STUDY DESIGN:

Study Type – Observational

Observational method – Cohort

Time perspective – Prospective

STUDY SITE: - Paediatric patients admitted in AIIMS NEW DELHI, and planned for operation in general anaesthesia using LMA. Patients will be assessed during the preoperative visit and inside the operation theatres.

ETHICS AND CONSENT: -For conducting the study Institutional ethics committee approval will be taken and written informed consent/assent will be obtained from the parents/ legal guardians of children (Assent for children more than 8 years). This study will also be registered with clinical trial registry.

STUDY DURATION- 2 years

SAMPLE SIZE:- A full search of indexed journals (NCBI, PubMed, Index Medicus, Medline etc.) with the terms “ultrasound”, “difficult LMA placement” , “postoperative airway obstruction”, “OSA post LMA”, “Pediatric difficult airway” didn’t yield any outcome. We intend to proceed as a pilot study. Sample size -300

RANDOMIZATION AND BLINDING: - There will be no randomization and concealment. Patient and the anaesthesiologist inserting the LMA will be completely blinded to the airway assessment findings. (Double Blinding)

INTERVENTION: - Device: Ultrasound, Proseal LMA

SELECTION CRITERIA

INCLUSION CRITERIA

a.    Children of age group 1-10 years.

b.   Both male and female children.

c.   Children undergoing surgery under general anesthesia using SAD.

d.   Parents or legal guardians giving consent.

EXCLUSION CRITERIA

1. Parents or surrogates not giving consent.

2. Patients with oropharyngeal pathology.

3. Patients with risk of aspiration.

4. Airway anomalies or syndromes related with difficult airway.

5. Presence of active pulmonary disease and poor chest compliance

6. Preoperative oxygen saturation at room air <95%

7. Tracheotomy 


We will use sonography to  measure Tongue thickness, Tongue cross-sectional area, Tongue volume, Oral cavity height, Tongue thickness/oral cavity height, Hyomental distance ratio (HMD) in the operation theatre before inducing the child in order to assess

1. DIFFICULT MASK VENTILATION 


later after induction and preoxygenation we will assess 

2. DIFFICULT LMA PLACEMENT

An.   

       after LMA removal in the recovery room we will assess

       3. POST OPERATIVE AIRWAY OBSTRUCTION 

        

     These outcome parameters will be assessed and graded by the concerned anaesthesiologist and we will later co-relate the sonographic measurements and outcome parameters to prove our study.

1. 

 
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