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CTRI Number  CTRI/2020/03/023887 [Registered on: 11/03/2020] Trial Registered Prospectively
Last Modified On: 27/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to see the effect of different ventilator settings on blood oxygen levels under general anesthesia 
Scientific Title of Study   Use of Proseal laryngeal mask airway with pressure controlled ventilation with positive end expiratory pressure in improving oxygenation in paediatric population  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arpit Singh 
Designation  Junior Resident 
Affiliation  Maulana Azad Medical college and associated Lok nayak hospital 
Address  Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi
Bahadur Shah Zafar Marg New Delhi
Central
DELHI
110002
India 
Phone  9911962715  
Fax    
Email  hobbygator@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  U C Verma 
Designation  Director Professor 
Affiliation  Maulana Azad Medical college and associated Lok nayak hospital 
Address  Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi
Bahadur Shah Zafar Marg New Delhi
Central
DELHI
110002
India 
Phone  9968604211  
Fax    
Email  ucverma2k@gmail.com  
 
Details of Contact Person
Public Query
 
Name  U C Verma 
Designation  Director Professor 
Affiliation  Maulana Azad Medical college and associated Lok nayak hospital 
Address  Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi
Bahadur Shah Zafar Marg New Delhi
Central
DELHI
110002
India 
Phone  9968604211  
Fax    
Email  ucverma2k@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi  
 
Primary Sponsor  
Name  Department of Anaesthesiology and Intensive Care 
Address  Maulana Azad Medical College, Bahadur Shah Zafar Marg, 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 
Arpit Singh  Lok Nayak Hospital  Department of Anaesthesiology and Intensive Care, B.L. Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi
Central
DELHI 
9911962715

hobbygator@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College   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  Group PEEP  A PEEP of 5cm of H2O applied in pressure controlled mode of ventilation  
Comparator Agent  Group ZEEP  A PEEP of 0cm of H2O applied in pressure controlled mode of ventilation  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.American society of anesthesiologist (ASA) physical status I
2.Patients undergoing surgical procedures permitting the use of supraglottic devices 
 
ExclusionCriteria 
Details  1.Any upper or lower respiratory infections, asthma, cystic fibrosis etc.
2.Patient at risk of aspiration.
3.Patient with anticipated difficult airway.
4.Patients with reduced lung compliance, obesity or those with musculoskeletal disorders.
5.Patient undergoing spine and thoracoabdominal surgeries.
6.Patients requiring surgeries in prone or lateral positions.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Partial pressure of O2 (PaO2)   30 mins after the institution of positive end expiratory pressure 
 
Secondary Outcome  
Outcome  TimePoints 
Oropharyngeal seal pressure  After successful placement of the Proseal LMA. 
Partial pressure of CO2 (PaCO2)  30 mins after the institution of positive end expiratory pressure 
Arterial blood pH   30 mins after the institution of positive end expiratory pressure 
Any co-relation between the fibre optic grading and the Partial pressure of O2 (PaO2) levels  30 mins after the institution of positive end expiratory pressure 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/03/2020 
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)?  

Brief Summary  

Endotracheal intubation or bag-and-mask ventilation have been the mainstays of airway management for several decades. In 1983, this changed with the invention of the laryngeal mask airway (LMA) which provided ease of placement and hands-free maintenance along with a relatively secure airway. LMA is increasingly being used in all patient population including children and has been found to be very safe and efficacious in various studies.

In the paediatric age group, the outward recoil of the chest wall is low, but the inward lung recoil is similar to that of a young adult. As the Functional Residual Capacity (FRC) is the lung volume at which the outward recoil of the chest wall exactly balances that of the inward recoil of the lungs, this leads to a reduced FRC in children. In awake state, the FRC is maintained by mechanisms such as active diaphragmatic and intercostal expiratory tone, but under general anaesthesia the closing volume tends to increase and the functional residual capacity decreases resulting in atelectasis and subsequent decreased arterial oxygenation. 

The application of adequate tidal volumes and a positive end-expiratory pressure (PEEP) play an important role in counteracting this airway closure and atelectasis in paediatric patients under general anaesthesia. This is usually achieved by using an endotracheal tube. However the ProSeal LMA (PLMA) has been shown to form a more effective seal than the Classic LMA and can be used to deliver PEEP which may improve gas exchange in children.5.6

There are few studies evaluating the use of PEEP with a supraglottic airway device in the paediatric age group in an attempt to minimise small airway closure. Hence we thought it worthwhile to compare the use of PLMA for pressure controlled ventilation with and without PEEP for improving oxygenation in paediatric patients.

 
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