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CTRI Number  CTRI/2025/03/081713 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of AIR-Q vs AMBUAURAGAIN for tracheal intubation in pediatric patient under general anesthesia using microcuff tube. 
Scientific Title of Study   A randomized comparative study to compare AIR-Q vs AMBUAURAGAIN as conduit for blind tracheal intubation using microcuff tube in pediatric patient under general anesthesia in Department of Anesthesia, SMS Medical college, Jaipur 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neelam Dogra 
Designation  Senior professor 
Affiliation  Sawai man singh medical college and attached hospitals jaipur 
Address  Department of anaesthesia sawai man singh medical college and attached hospital Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  Neelam_dogra24@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neelam Dogra 
Designation  Senior professor 
Affiliation  Sawai man singh medical college and attached hospitals jaipur 
Address  Department of anaesthesia sawai man singh medical college and attached hospital Jaipur RAJASTHAN 302004 India

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  Neelam_dogra24@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Priya Rathore 
Designation  Resident doctor 
Affiliation  Sawai man singh medical college and attached hospitals jaipur 
Address  Department of anaesthesia sawai man singh medical college and attached hospital jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9928370762  
Fax    
Email  rathorepriya151@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia sawai man singh medical college and attached hospital jaipur 
 
Primary Sponsor  
Name  Department of anaesthesia sawai man singh medical college and attached hospital jaipur 
Address  Department of anaesthesia sawai man singh medical college and attached hospital jaipur 
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 Neelam Dogra   Sawai man singh medical college and attached hospital jaipur  Department of anaesthesia sawai man singh medical and attached hospital Jaipur Rajasthan 302004
Jaipur
RAJASTHAN 		 9928709289

Neelam_dogra24@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF ETHICS COMMITTEE SMS MEDIA COLLEGE AND ATTACHED HOSPITALS JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N51||Disorders of male genital organs in diseases classified elsewhere, (2) ICD-10 Condition: Q541||Hypospadias, penile, (3) ICD-10 Condition: Q542||Hypospadias, penoscrotal,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AIR-Q  To compare AIR-Q intubating laryngeal airway with AMBUAURAGAIN laryngeal mask for blind tracheal intubation with microcuff tube in pediatric patient undergoing elective surgery under general anaesthesia. 
Comparator Agent  AMBUAURAGAIN  To compare AIR-Q intubating laryngeal airway with AMBUAURAGAIN laryngeal mask for blind tracheal intubation with microcuff tube in pediatric patient undergoing elective surgery under general anesthesia. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1)ASA grade 1 and 2
2)Undergoing elective surgery requiring endotracheal intubation 3)Parent/guardian willing to provide consent for participation  
 
ExclusionCriteria 
Details  1. Abnormal airway anatomy assessed by – passive mouth
opening, micrognathia, thyromental distance, and submental
compliance, intra oral growth.
2. Patient with cardiopulmonary disease
3. Severe gastrointestinal reflux
4.History of upper respiratory tract infection in previous 14 days.
5.Patient should not be part of other study
6. Non co-operative patient 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate first attempt success rate of blind tracheal intubation through AIR-Q and AMBUAURAGAIN using microcuff tube in pediatric patient.  To assess and compare intubating characteristics of AIR-Q versus AMBUAURAGAIN in terms of:
1.Time taken for intubation.
2.Number of attempts for blind tracheal intubation.
3.Maneuver applied for intubation.
4.Time taken for removal of device after intubation is accomplished. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare insertion characteristics of AIR-Q versus AMBUAURAGAIN in terms of:  1)Time taken in insertion of devices.
2) Number of attempts for insertion.
3)Ease of insertion.
4)Oropharyngeal leak pressure. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   14/03/2025 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Patient satisfying inclusion criteria and PAC fitness will be selected and taken into
OT. Patient will be identified, fasting status and take informed written consent will be
checked. Randomization will be done using sealed envelope method and the type of tube
will be selected. Group A airway will be secured with AIR_Q ILA then intubated with
microcuff ET Tube (n=50) and Group B airway secured with AMBUAURAGAIN and
then intubated with microcuff ET Tube (n=50)
Routine monitors will be attached, vitals will be monitored continuously.
Baseline vitals like Non-invasive blood pressure(NIBP), pulse rate(PR), oxygen
saturation(SpO2), will be noted. Intravenous fluid will be started as per hospital protocol
in already secured peripheral IV line.
Inj. Glycopyrrolate (0.005 mg/kg)IV +Inj.midazolam(0.05mg/kg)IV given. Inj.
Fentanyl (2mcg/kg) will be given as analgesic
After preoxygenation with 100% O2,Induction of anaesthesia will be done with
Inj. Propofol (2.5-3mg/kg).Relaxation will be obtained with Inj. Atracurium 0.5mg/kg
and patient will be ventilated for 3 minutes with 5L of oxygen.
LMA will be introduced into the patient and cuff will be inflated with appropriate amount
of air ( max 10ml). Correct placement of LMA will be confirmed with bilateral chest
inflation, a square wave capnogarphy and fibreoptic bronchoscopy.
A lubricated microcuff endotracheal tube either AIR-Q ILA in group A or
AMBUAURAGAIN group B will be inserted . Cuff will be inflated to the desired level.
Correct placement of endotracheal tube in the trachea will be confirmed with equal
bilateral air entry and capnograph tracing.
After successful ET tube insertion, the LMA will be deflated and removed while
the ET Tube will be secured. Anaesthesia will be maintained with inhaled sevoflurane
2%+ 60%N2O+40%O2 and Inj. atracurium 0.1mg/kg (maintenance dose).
HR, SpO2, NIBP and EtCO2 will bemonitored continuously during the procedure.
Post operative complication like post extubation cough, stridor and laryngospasm
will be recorded in the immediate post- operative period and one hour after extubation.
 
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