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CTRI Number  CTRI/2024/04/065380 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 06/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Number of patients having difficult mask ventilation and difficult insertion of ventilation tube into the windpipe during open heart surgery (bypass surgery) 
Scientific Title of Study   Incidence and predictors of difficult mask ventilation and intubation in patients scheduled for coronary artery bypass surgery – a prospective observational study 
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 Aneesha Chris Wilfred 
Designation  Post Graduate Registrar 
Affiliation  Christian Medical College  
Address  Junior Resident, Room no: 107, Department of Anesthesiology, Christian Medical College, Vellore 632004

Vellore
TAMIL NADU
632004
India 
Phone  9487267076  
Fax    
Email  aneeshawilfred@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Balaji Kuppuswamy 
Designation  Professor 
Affiliation  Christian Medical College  
Address  Room no:2105, Department of Anesthesiology, Christian Medical College, Vellore 632004

Vellore
TAMIL NADU
632004
India 
Phone  7406777127  
Fax    
Email  balooswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Balaji Kuppuswamy 
Designation  Professor 
Affiliation  Christian Medical College  
Address  Room no: 2105, Department of Anesthesiology, Christian Medical College, Vellore 632004

Vellore
TAMIL NADU
632004
India 
Phone  7406777127  
Fax    
Email  balooswamy@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical College, Vellore 632004, Tamil Nadu, India 
 
Primary Sponsor  
Name  Dr Aneesha Chris Wilfred 
Address  Post Graduate Registrar, Room no: 107 Junior Resident, Department of Anesthesiology, Christian Medical College, Vellore 632004, Tamil Nadu, India 
Type of Sponsor  Other [SELF] 
 
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 Aneesha Chris Wilfred  Christian Medical College and Hospital  Cardiothoracic surgery operation theatre, Department of Anesthesiology, Vellore 632004
Vellore
TAMIL NADU 
9487267076

aneeshawilfred@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical College, Vellore.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age between 18 to 70 years
2.ASA 3 and ASA 4 patients undergoing Coronary Atery Bypass Grafting (CABG)
3.BMI more than 18
4.Ability to understand protocol and give informed consent 
 
ExclusionCriteria 
Details  1.Patients who are planned for Rapid Sequence Induction (RSI)
2.Patients who are on tracheostomy tube
3.Pregnant patients
4.Patients who do not consent for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of difficult mask ventilation and intubation in patients undergoing coronary artery bypass surgery using difficult mask ventilation grading and Intubation difficulty scale  At the time of induction of anesthesia in the operation theatre 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the predictors of difficult mask ventilation and intubation in patients undergoing coronary artery bypass surgery

To assess the correlation of clinical prediction of difficult airway with difficult mask ventilation and difficult intubation. 
Preoperatively in the ward where patients are admitted.
Intraoperatively at the time of mask ventilation and intubation 
 
Target Sample Size   Total Sample Size="175"
Sample Size from India="175" 
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)   17/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Difficult airway is defined as ‘’the clinical situation in which a conventionally trained anesthesiologist experiences difficulty with face mask ventilation of the upper airway, difficulty with tracheal intubation or both.’’ Predictors of difficult airway include age, sex, BMI, ASA classification, external signs like, facies, facial hair, body habitus, head and neck pathology, airway examination including cervical spine mobility ,dentition, thyromental distance, sternomental distance, jaw protrusion, mallampatti classification, neck circumference, history of snoring.

 

Patients undergoing coronary artery bypass grafting invariably have physiologically low cardiac reserve. They are also mostly associated with obesity, diabetes mellitus, hypertension, metabolic syndrome making them difficult airways. Duration of successful intubation (DSI) in these high risk patients should be less in order to prevent adverse events on myocardial oxygenation while securing the airway. Therefore it is essential to preoperatively clinically assess the airway and determine the predictors of difficult mask ventilation and intubation. In  this study we also assess the correlation of our clinical prediction with real time mask ventilation and intubation.

 

 The ASA originally defined difficult intubation as requiring more than 3 attempts or taking  longer than 10 minutes to complete using conventional laryngoscopy.

In order to assess difficult tracheal intubation and difficult mask ventilation there are scales of difficulty. Difficult mask ventilation grading includes usage of airway adjuncts, 2 hand technique, usage of muscle relaxant. Intubation difficulty scale includes 7 contributors namely, number of supplementary attempts, number of supplementary operators, alternative techniques used, glottic exposure (Cormack and lehane grading), lifting force applied during laryngoscopy, necessity of external laryngeal pressure and position of the vocal cords. Duration of successful intubation is also taken into account.

Patients undergoing coronary artery bypass graft surgery can have higher incidence of difficult airway. Awareness about the incidence and predictors of difficult airway in CABG patients will help the anesthesia provider in being adequately prepared for management of a difficult airway situation thereby reducing the laryngoscopy related adverse events on myocardial oxygenation.

 

Hence in this observational study we will be clinically assessing the airway of patients undergoing coronary artery bypass surgery preoperatively and determine the difficulty of mask ventilation and intubation. 
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