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CTRI Number  CTRI/2024/11/077164 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparing the usefulness of two types of masks used to provide breaths during general anaesthesia  
Scientific Title of Study   Comparing the feasibility of ventilation with Novel nasal PAP device with conventional facemask in patients receiving 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  Dr Muralidharan 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences,Mangalagiri 
Address  Department of Anaesthesia,AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  9994972589  
Fax    
Email  muralikayal123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Eeshwar MV 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences,Mangalagiri 
Address  Room No.1052, Dept of Anaesthesia, AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  9740122272  
Fax    
Email  dreeshwarmv@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Muralidharan 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences,Mangalagiri 
Address  Department of Anaesthesia,AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  9994972589  
Fax    
Email  muralikayal123@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesiology AIIMS Mangalagiri Guntur District Andhra Pradesh Pin 522503 
 
Primary Sponsor  
Name  AIIMSMangalagiri 
Address  Department of Anaesthesia AIIMS Mangalagiri Guntur District Andhra pradesh Pincode-522503 
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 Muralidharan  AIIMS,Mangalagiri  Department of Anaesthesia,AIIMS Mangalagiri
Guntur
ANDHRA PRADESH 
9994972589

muralikayal123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS,Mangalagiri,Institute 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  Conventional Facemask  Conventional facemask will be used to ventilate patients initally as the standard of care for all patients for about a minute under general anaesthesia and the parameters will be recorded every 15 seconds. 
Intervention  Novel Nasal PAP device  Novel nasal PAP device will be used to ventilate patients for about a minute under general anaesthesia and the parameters will be recorded every 15 seconds. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of ASA I-III aged from 18 to 65 yrs are included in the study 
 
ExclusionCriteria 
Details  Patients refusal
Patients with anticipated difficult mask ventilation
Patients with unanticipated difficult mask ventilation


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•To measure delta Vt (difference between set tidal volume and delivered tidal volume) using both Super NO2VA and conventional face mask  T0-Baseline(Post Induction)
T1-15 secs
T2-30 secs
T3-45 secs
T4-60 secs 
 
Secondary Outcome  
Outcome  TimePoints 
•Change in the peak airway pressure (Paw)
•Change in SpO2
•Measure EtCO2 values with both techniques
•Grade the EtCO2 trace
•Monitor the use of airway adjuncts
•Agreeability between Super NO2VATM and conventional face mask
 
T0-Baseline(Post Induction)
T1-15 secs
T2-30 secs
T3-45 secs
T4-60 secs 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/01/2025 
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="11"
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  

Mask ventilation is pivotal during general anaesthesia (GA) especially at induction, serving as the primary means of ventilation before securing a definitive airway. It encompasses two critical aspects: ensuring an airtight seal between the mask and the patient’s face to prevent gas leakage and maintaining an unobstructed upper airway. Despite this, patients are prone to airway obstruction. Using the 2-hand technique of mask ventilation and / or use of airway adjuncts such as oropharyngeal or nasopharyngeal airway might help relieve this obstruction.

Nasal mask ventilation directs inspired air through the nasal cavity, countering gravity’s influence on the soft palate and tongue, thereby maintaining upper airway patency. Consequently, direct nasal ventilation may offer improved ventilation efficacy and a more natural breathing pattern. Continuous positive airway pressure (CPAP), delivered via non-invasive ventilation masks not only prevent upper airway collapse but also are being used in the ICUs to ventilate patients and also pre-oxygenate before intubating the critically ill. Literature also suggests using the Rendell Becker Soucek mask and even paediatric facemasks can be used for nasal ventilation in children and edentulous patients but these do not provide positive airway pressure (PAP) and neither are specifically designed to give a perfect fit. Super NO2VATM is specifically designed for nasal ventilation and also has the advantage of providing positive pressure ventilation that would maintain patency of upper airway. This novel device has been introduced in the market for its use in obese patients with obstructive sleep apnoea who are posted for procedures under sedation. In this study, we are using this device for mask-ventilating patients at the start of general anaesthesia and trying to compare its effectiveness with that of the Conventional Facemask technique of ventilation


 
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