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CTRI Number  CTRI/2024/03/064296 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 18/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   how the height of the operating table affects the ability to properly insert a breathing device (supraglottic airway device) in children having surgery while under general anesthesia. 
Scientific Title of Study   Effect of Different Operating Table Height on Successful Insertion of Supraglottic Airway Device in Pediatric Patients Undergoing Elective Surgery Under General Anaesthesia 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Touseef Khan 
Designation  PG Anaesthesia  
Affiliation  ABVIMS and Dr RML Hospital  
Address  Room no. 301, 3rd floor, Department OF Anaesthesia, PGI building, ABVIMS & Dr RML Hospital

New Delhi
DELHI
110001
India 
Phone  9013234450  
Fax    
Email  nickkhan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti Singh 
Designation  Associate professor  
Affiliation  ABVIMS and Dr RML Hospital  
Address  Room no. 301, 3rd floor, Department OF Anaesthesia, PGI building, ABVIMS & Dr RML Hospital

New Delhi
DELHI
110001
India 
Phone  9910241887  
Fax    
Email  drjyoti.md@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti Singh 
Designation  Associate professor  
Affiliation  ABVIMS and Dr RML Hospital  
Address  Room no. 301, 3rd floor, Department OF Anaesthesia, PGI building, ABVIMS & Dr RML Hospital


DELHI
110001
India 
Phone  9910241887  
Fax    
Email  drjyoti.md@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS Dr RML hospital Baba Kharaksingh Marg, New Delhi 110001 
 
Primary Sponsor  
Name  ABVIMS and Dr RML hospital  
Address  Baba kharak Singh mark, New Delhi 
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 
Touseef Khan  ABVIMS and Dr RML Hospital, New Delhi   Room no.304, 3rd floor, department of Anaesthesiology, PGI building,Dr RML Hospital, Baba kharak Singh Marg, New Delhi 110001
New Delhi
DELHI 
9013234450

nickkhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.RML hospital,New Delhi ethics committee   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 
Comparator Agent  Comparing ease of insertion of supraglottic airway device at different level of table heights   After informed consent patient will be taken in OT standard monitors will be attached. After securing IV line patient will be induced. Patients will be divided in two groups one at the level of umbilicus and the parameters will be compared with second group from 0 minute to 5 minute. 
Comparator Agent  comparing the ease of insertion of supraglottic airway device at different table heights  After informed consent patient will be taken in OT standard monitors will be attached. After securing IV line patient will be induced. Patients will be divided in two groups in second group at the level of anterior superior iliac spine and ease of insertion of supraglottic airway device will be compared with first group from 0 minute to 5 minutes. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  ASA GRADE 1 AND 2
 
 
ExclusionCriteria 
Details  Trauma, Tumor or deformity of upper airway
Patient with thyroid and neck swelling
Fracture and deformity of cervical spine
Past history of difficult intubation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Appearance of EtCO2 waveform on capnography.
delivery of set tidal volume
successful gastric tube insertion through gastric port of supraglottic airway device 
0 minute, 3 minute and 5 minute  
 
Secondary Outcome  
Outcome  TimePoints 
The duration of Insertion which will be measured from the placement of SAD at oral orifice to the appearance of EtCO2 waveform.  0 second 30 seconds & 1 minute 
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
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 2/ Phase 3 
Date of First Enrollment (India)   25/03/2024 
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="5"
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  

General anaesthesia is a state of deep sleep or unconsciousness, during which the patient has no awareness or sensation. Airway management is a crucial period during the administration of general anaesthesia. One of the ways of maintenance of airway involves placement of a supraglottic airway device that sits above the vocal cords, which allows for adequate delivery of oxygen and anaesthetic gases to lungs.

Supra Glottic Airway devices have become a standard management, filling a niche between the face mask and tracheal tube in terms of both anatomical position and degree of invasiveness. 2nd generation supraglottic airway device with gastric port stands out as the latest, most intricate, and potentially, the most impactful among specialized laryngeal mask devices. The primary objective in its design was to create a laryngeal mask with enhanced ventilatory properties while also offering safeguards against regurgitation and gastric insufflation. The key innovations include a modified cuff and a drainage tube. 2nd generation supraglottic airway device functions as a double mask, establishing two end-to-end connections: one with the respiratory tract and the other with the gastrointestinal tract.

2nd generation supraglottic airway device wit gastric port is used commonly as it provides numerous advantages when compared to endotracheal intubation, including superior haemodynamic stability, less airway trauma, superior patients comfort, and offers protection from barotrauma with smooth awakening of the patient.1 The success rate of SAD insertion ranges from 77% to 90%, and suboptimal positioning occurs in 30–66% of cases.2 Airway morbidity still occurs even with the apparent proper insertion of SAD3. As such, the SAD should be inserted and placed in an optimal position to minimize complications and allow for maximal functionality.

Operating table height can influence task performance and physical/mental workload of anaesthesiologist 4. The physical effort required for bag and mask ventilation and endotracheal intubation is influenced by the positioning of the patient and the height of the operating table. This positioning relies on maintaining an unobstructed linear path between the larynx and the observer’s eye. Achieving this necessitates precise patient positioning, which, in turn, depends on employing various maneuvers and adjusting the height of the operating table. Incorrect body posture can have detrimental effects on the health of an anaesthetist, potentially leading to back problems.

 Children have been the earliest patrons of anaesthesiology from its earliest clinical applications of surgical anaesthesia. SAD is widely used in pediatric anaesthesia to maintain airway during surgery.

 To the best of our knowledge, no similar study was conducted on investigating the optimal table height for SAD placement in pediatric population. So, we propose a study to compare two operating table heights to find out which could allow for a successful insertion of SAD at the first attempt in pediatric population.

 
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