FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/013691 [Registered on: 04/05/2018] Trial Registered Prospectively
Last Modified On: 04/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Effectiveness of bag and mask ventilation done by Consultant Anesthesiologist vs Resident Anesthesiology Postgraduate  
Scientific Title of Study   Comparison of effectiveness of mask ventilation by Consultant Anesthesiologist and Resident Anesthesiology Postgraduate with and without using Airway Adjuncts: A Prospective Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ambika Coondoo 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal Academy Of Higher Education 
Address  Department Of Anaesthesiology Kasturba Medical College Manipal -576104

Udupi
KARNATAKA
576104
India 
Phone  9535619084  
Fax    
Email  ambikacoondoo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Kumar H D 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal Academy Of Higher Education 
Address  Department of Anaesthesiology Kasturba Medical College Manipal -576104

Udupi
KARNATAKA
576104
India 
Phone  9008415858  
Fax    
Email  arunhd2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yogesh Gaude 
Designation  Assistant professor 
Affiliation  Kasturba Medical College,Manipal Academy of Higher Education 
Address  Department of Anaesthesiology Kasturba Medical College Manipal -576104

Udupi
KARNATAKA
576104
India 
Phone  8904380406  
Fax    
Email  yogeshgaude@gmail.com  
 
Source of Monetary or Material Support  
PG Thesis Fund , Manipal University, Madhavnagar, Manipal, Karnataka, India  
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Private 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 Ambika Coondoo  Kasturba Hospital, Manipal   Department of Anaesthesiology, OT complex,Kasturba Hospital,Manipal University, Madhav Nagar, Manipal Udupi KARNATAKA
Udupi
KARNATAKA 
9535619084

ambikacoondoo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital, Manipal   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  American Society Of Anesthesiologists physical status 1 and 2 ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group (NA)-No airway adjunct  Bag and mask ventilation with Triple Maneuver that includes Head Tilt, Chin Lift, Jaw thrust. 
Comparator Agent  Group (NP)-Nasopharyngeal Airway adjunct  Bag and mask ventilation with Nasopharyngeal Airway 
Comparator Agent  Group (OP)-Oropharyngeal Airway adjunct  Bag and mask ventilation with Oropharyngeal Airway 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA physical status I and II adult surgical patients aged between 18-65 years
2.Patients undergoing elective surgery with Mallampati Class I and II scheduled for standardized procedures under general anaesthesia  
 
ExclusionCriteria 
Details  1.Patients with BMI<18.5 Kg/m² or > 29.9Kg/m²
2.Requiring rapid sequence induction and intubation
3.Obstructive sleep apnea or history of snoring
4.Documented history of Difficult Airway in Previous Surgeries
5.Edentulous
6.Obvious facial deformities
7.Oropharyngeal Abnormalities
8.COPD patients /Asthmatics/Smokers
9.ENT Surgeries
10.Patients on Anticoagulant Therapy /Thrombocytopenia
11.Pregnant females
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the exhaled tidal volumes with or without airway adjuncts   After Induction of anesthesia,when Bag and mask ventilation is being performed 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the learning curve of a junior resident anesthesiologist   during induction of anaesthesia 
 
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   N/A 
Date of First Enrollment (India)   07/05/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Mask ventilation is an important management skill. Creating a seal between the mask and the patient’s face by lifting the mandible (chin lift) and providing jaw thrust allows for positive pressure (assisted) ventilation.  Mask ventilation may be required to assist with ventilation before intubation to achieve preoxygenation. Thus if intubation proves to be difficult after induction , mask ventilation can provide critical oxygenation and ventilation between laryngoscopy attempts.

Koga et al in his study compares between a cuffed oropharyngeal airway adjunct and a Guedel Airway with the final conclusion that an oropharyngeal airway plays a better role in opening the airways to pre-oxygenate a patient during ventillation.Similiarly in our study we will be comparing an oropharyngeal airway device with that of a nasopharyngeal airway device to see which is more efficacious in opening the airways of a patient under general anaesthesia and assist in breathing. Langeron et al stresses on how the use of airway adjuncts as those used in the proposed study above help to ventilate patients with suspected difficult airway. Alexander et al on the other hand compares the ease of insertion of the airways based on training and experience.

This study will also shed some light on the learning curve of a resident (postgraduate) anaestheesiologist with minimum 6 months experience in the teaching curriculum

 
Close