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CTRI Number  CTRI/2021/03/032076 [Registered on: 17/03/2021] Trial Registered Prospectively
Last Modified On: 17/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare between two medical devices for ease of securing airway in small children who are being operated using general anaesthesia. 
Scientific Title of Study   Comparison of the BlockBusterTM and air-Q® supraglottic airway devices as a conduit to blind endotracheal intubation in paediatric patients: A randomised controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arunima Pattanayak 
Designation  Post Graduate Trainee 
Affiliation  AIIMS, Patna 
Address  Department of Anaesthesiology, All india institute of medical sciences patna, Aurangabad road, Phulwarisharif, Patna.

Patna
BIHAR
801507
India 
Phone  08895201483  
Fax    
Email  drarunimap@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhyuday Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS, Patna 
Address  Department of Anaesthesiology, All india institute of medical sciences patna, Aurangabad road, Phulwarisharif, Patna.

Patna
BIHAR
801507
India 
Phone  9013512403  
Fax    
Email  drabhyu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arunima Pattanayak 
Designation  Post Graduate Trainee 
Affiliation  AIIMS, Patna 
Address  Department of Anaesthesiology, All india institute of medical sciences patna, Aurangabad road, Phulwarisharif, Patna.

Patna
BIHAR
801507
India 
Phone  08895201483  
Fax    
Email  drarunimap@yahoo.com  
 
Source of Monetary or Material Support  
All india institute of medical sciences Patna, Patna. 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Patna 
Address  All India Institute Of Medical sciences Patna, Aurangabad Road, Phulwarisharif, Patna, Bihar-801507 
Type of Sponsor  Research institution and hospital 
 
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 Arunima Pattanayak  All India Institute Of Medical Sciences Patna, Patna.  OT complex, A Block, Fifth floor, IPD Building.
Patna
BIHAR 		 8895201483

drarunimap@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute Of Medical Sciences Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  air-Q® masked laryngeal airways  An advanced supraglottic airway device with the property of allowing passage of endotracheal tube through it while being able to ventilate the patient during non spontaneous respiration in surgical procedures requiring general anesthesia, will be used for placement of a pvc endotracheal tube in paediatric patients with asa physical status 1/2. 
Intervention  BlockBusterTM laryngeal mask airway.  An advanced supraglottic airway device with the property of allowing passage of endotracheal tube through it while being able to ventilate the patient during non spontaneous respiration in surgical procedures requiring general anesthesia, will be used for placement of a pvc endotracheal tube in paediatric patients with asa physical status 1/2. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  10.00 Year(s)
Gender  Both 
Details  ASA physical status I and II
ages 6 months to 10 years
weighing 5 to 30 kg
patients undergoing elective surgeries under general anesthesia 
 
ExclusionCriteria 
Details  Refusal by the guardian
Anticipated difficult airway
Children who had previously failed conventional direct laryngoscopy.
History of cardiopulmonary disease
Weight-for-height greater than >3 standard deviations above WHO Child Growth Standards median( in age < 5 years) or BMI>30 (in age > 5 years)
Presence of mass/lesion in the airway
Patient posted for emergency procedures
Head and Neck surgery
Any surgical procedure with expected postoperative ICU admission 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
percentage of successful blind endotracheal intubation in a single attempt.  after placing lma followed by successful attempt of intubation will be recorded in the intraoperative period. 
 
Secondary Outcome  
Outcome  TimePoints 
peak pressure, the number of attempts required for successful placement of SAD,the glottic view through fiberoptic bronchoscope, the time required to successfully intubate the patient.   To be assessed after securing supraglottic device and endotracheal intubation.The post anesthesia related problems are to be assessed after surgery in the post anaesthesia care unit and after 24 hours after. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   21/03/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be made available on request to the primary investigator.

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 01-01-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Failure in the airway management and hypoxia can lead to irreversible brain damage within only a few minutes. Thus it is extremely important that there be methods for fast securing of the airway, in patients undergoing general anesthesia, that must be adequate for ventilation and oxygenation. 

Rationale:

Complications related to the management of the pediatric difficult airway make it imperative to have a device that may facilitate blind intubation in difficult airway situations. According to a study conducted by Kleine-Brueggeney M et.al in 2015, Visualised blind intubation was possible in 15% with the air-Q® Masked Laryngeal Airways and in 3% with the AmbuAura-i. According to a study conducted in healthy adults, by Archana Endigeri et al. The first attempt success rate of blind tracheal intubation was 90% in BlockBusterTM LMA. The BlockBusterTM LMA demonstrated higher seal pressures than FASTRACH ILMA. 

Aim: To determine the efficacy of laryngeal mask airways (  BlockbusterTM laryngeal mask airways vs air-Q® masked Laryngeal Airways) in acting as a conduit for successful blind endotracheal intubation in paediatric patients undergoing non emergency surgeries under general anaesthesia.

Objectives: 

  1. Primary objective(s): To evaluate and compare the percentage of successful blind endotracheal intubation in a single attempt.

  2. Secondary objective(s): To evaluate and compare - The number of attempts required for successful placement of SAD, glottic view through fiberoptic bronchoscope, time required to successfully intubate the patient, incidence of peri and post procedural complications.

 Methodology: 

  1. Study design: A randomised controlled trial

  2. Sampling population: All patients (ASA 1 & 2)  between age 6 months to 10 years coming to AIIMS Patna for elective surgical procedures requiring administering of general anaesthesia.

The study population will be divided into two groups.

Group 1:-  This group will consist of patients in which air-Q® SAD will be used as a conduit for blind endotracheal intubation. 

Group 2: This group will consist of patients in which BlockBusterTM SAD will be used as a conduit for blind endotracheal intubation. 

Sample size : 80 (40 in each group)

Statistical analysis:- Categorical data will be expressed as frequency and percentage, and normally distributed continuous data will be reported as the mean with standard deviation, otherwise as median with quartiles. Parametric data will be compared using an unpaired t‐test. Non‐parametric data will be compared with Fisher’s exact test or Chi‐square test. Data will be presented as mean ± standard deviation with P < 0.05 as statistically significant.

There is no added risk in application of these devices. 

This study would help in selecting  a better SGA for blind intubation in a difficult airway scenario.

 
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