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
|
|
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
|
|
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 |