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CTRI Number  CTRI/2024/01/062054 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Comparison of MC-COY blade laryngoscope versus macintosh laryngoscope in new Anaesthesiology residents for intubation in General anaesthesia 
Scientific Title of Study   Comparison of MC-COY blade laryngoscope versus macintosh laryngoscope in novice Anaesthesiology residents for laryngoscopy and intubation 
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 Hemlata Kamat 
Designation  Professor Department of Anaeshesiology 
Affiliation  H M Patel center for medical care and education 
Address  Shri Krishna Hospital Karamsad
hemlatavk@charutarhealth.org
Anand
GUJARAT
388325
India 
Phone  9909929422  
Fax    
Email  shuklavidhi05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidhi Shukla 
Designation  Resident Of Department Of Anaesthesiology 
Affiliation  H M Patel center for medical care and education 
Address  Room No 20 Pg Hostel Shri Krishna Hospital, Karamsad
Shri Krishna Hospital Karamsad
Anand
GUJARAT
388325
India 
Phone  7698080474  
Fax    
Email  shuklavidhi05@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR VIDHI SHUKLA  
Designation  RESIDENT DEPARTMENT OF ANESTHESIOLOGY  
Affiliation  H M Patel center for medical care and education 
Address  ROOM No 20 PG HOSTEL SHRI KRISHNA HOSPITAL KARAMSAD


GUJARAT
388325
India 
Phone  7698080474  
Fax    
Email  shuklavidhi05@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna Hospital,Karamsad 
 
Primary Sponsor  
Name  Shri Krishna HospitalKaramsad 
Address  Karamsad,Anand 
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 Vidhishukla   Shri Krishna Hospital  Pramukh Swami medical College, Department of Anaesthesia Academic centre,Karamsad 388325
Anand
GUJARAT 		 7698080474

shuklavidhi05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University,Karamsad,Anand, Gujarat- 388325   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K639||Disease of intestine, unspecified,  
 
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  ION CRITERIA 1) Age 18 to 70 years 2)ASA Grade I to III 3) Mallampatti Grade I to III 4) Patients posted for elective surgery 5) Use of standard Portex cuffed Endotracheal tube only 6) Use of routine induction agents only  
 
ExclusionCriteria 
Details  Obstrectic patient 2) Head and neck surgeries 3) BMI > 35,morbid obese patient 4) Protruding upper incisors. 5) Macro/micrognathia 6) Limited Neck Extension on preoperative airway examination.  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
laryngeal exposure –Achievement of Cormack Lehane Grade I / II Grade 1: Most of glottis is visible Grade 2: The posterior aspect of glottis is visible Grade 3: Only epiglottis is seen, no part of laryngeal inlet is visible Grade 4: The epiglottis is not visible   6months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective: A).Success at first attempt intubation. B).To look for any complications: 1) Trauma to teeth & oral mucosa 2) Esophageal intubation 3) Desaturation due to inability to intubate in 1st attempt (spo292%) 4) Pressure response to intubation (alteration in BP 20% and HR 20% from baseline)in terms of additional amount of inj propofol required to maintain hemodynamics.   30 Seconds  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/02/2024 
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="0"
Months="6"
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   Patient undergoing elective surgery under general anesthesia (except obstrectic surgery) will be recruited in this study. Participants (novice residents) will be allotted in two groups , by asking them to pick a chit randomly from a box containing 15 chits . Some chits will be (group C)Mc-coy blade and other(group M) Macintosh blade for intubation. Once the residents are allotted in a particular group, he/she will continue to use the blade allotted to that group for laryngoscopy and intubation .Each resident will do about 8-9 intubations . -Pre anesthetic check up will be carried out in all the patients. -On arrival to operation theatre, standard intra-operative monitoring with electrocardiogram, pulse oximetry and non invasive and manual blood pressure will be attached and baseline vitals will be noted. -The laryngoscopy blade will be given according to allotted category. -In pre medication inj Glycopyrolate 0.005-0.01mg/kg, Inj Midazolam (0.1-.0.2mg/kg) iv, Inj fentanyl (1-2mcg/kg) , inj Lignocaine(2% preservative free )3 cc iv given Patient pre-oxygenated with 100 % O2 through closed circuit delivered via spontaneous ventilation for 3 minutes. The induction of anesthesia will be done with inj propofol according to weight (2-2.5mg/kg) muscle relaxation achieved with inj Succinyl-Choline (1.5-2mg/kg) . After achieving adequate muscle relaxation, in sniffing position laryngoscopy will be performed with laryngoscope blade 3 for female and blade 4 for male. The novice resident will be asked about glottic view that will be achieved by his/her at first attempt by showing them by Cormack Lehane classification chart .They will be asked to indicate the Cormack Lehane , grade 1/2 will be achieved by external laryngeal maneuvers after which intubation will be done by Portex endo-tracheal tube , if novice is not able to achieve grade 1 or 2 then adjustment of the blade or external laryngeal manipulations will be done . Total time of 30 seconds will be given to the novice resident for placement of the endotracheal tube , after that the senior resident will take over the procedure. The time duration will be noted from insertion of laryngoscope into oral cavity till attainment of 5-7 successive square waveforms in capnograpghy. In group M patient intubated with Mackintosh blade and In group -C patient will be intubated with Mc-coy blade . 
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