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CTRI Number  CTRI/2018/07/015064 [Registered on: 26/07/2018] Trial Registered Retrospectively
Last Modified On: 20/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A COMPARATIVE STUDY USING 2 TYPES OF LARYNGOSCOPIC BLADES TO VIEW VOCAL CORDS AND EASE TO PUT TRACHEAL TUBE THROUGH PATIENTS MOUTH IN ADULTS for BREATHING UNDER ANAESTHESIA. 
Scientific Title of Study   A COMPARATIVE CROSSOVER RANDOMIZED STUDY OF MILLERS AND MACINTOSH BLADE FOR LARYNGOSCOPIC VIEW AND EASE OF INTUBATING CONDITIONS IN ADULTS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anupama G 
Designation  Junior Resident 
Affiliation  M S Ramaiah Medical College 
Address  Department Of Anaesthesiology M S RAMAIAH MEDICAL COLLEGE Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9986209592  
Fax    
Email  dr.anugopal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nalini K B 
Designation  Assistant Proffesor 
Affiliation  RGUHS Bangalore 
Address  Department Of Anaesthesiology M S RAMAIAH MEDICAL COLLEGE Bangalore

Bangalore
KARNATAKA
560054
India 
Phone    
Fax    
Email  dr_kbnalini@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nalini K B 
Designation  Assistant Proffesor 
Affiliation  RGUHS, Bangalore 
Address  Department Of Anaesthesiology M S RAMAIAH MEDICAL COLLEGE Bangalore

Bangalore
KARNATAKA
560054
India 
Phone    
Fax    
Email  dr_kbnalini@yahoo.com  
 
Source of Monetary or Material Support  
Dr. NALINI. K. B Assistant Professor RAMAIAH MEDICAL COLLEGE 
 
Primary Sponsor  
Name  Dr NALINI KB 
Address  Assistant Professor Department Of Anaesthesiology MSRMC Bangalore. 
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 Anupama G  M S Ramaiah Hospital.  Operation Theatre M S Ramaiah Hospital.
Bangalore
KARNATAKA 
9986209592

dr.anugopal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ramaiah medical college ethics committee  Approved 
RAMAIAH MEDICAL COLLEGE ETHICS COMMITTEE.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Stable patients with no medical illness.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MAC INTOSH AND MILLER BLADE.  LARYNGOSCOPIC VIEW IS COMPARED USING MAC INTOSH AND MILLER BLADE. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.American Society of Anaesthesiologist grades I and II for elective surgeries under General anaesthesia. 
 
ExclusionCriteria 
Details  1.Patients who refuse to give consent,
2.Pregnant patients,
3.Patients who are considered full stomach,
4.Patients with anticipated difficult intubation,
5.Previous oral surgeries /oral thrush, pathology in neck,
-Ischemic heart disease patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
LARYNGOSCOPIC VIEW IS BETTER USING MILLER BLADE THEN WITH MACINTOSH BLADE.  At the end of 2years from start of study. 
 
Secondary Outcome  
Outcome  TimePoints 
EASE OF INTUBATION IS BETTER WITH MAC INTOSH BLADE THEN WIYH MILLER BLADE.  6 MONTHS 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
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)   15/10/2016 
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)  Closed to Recruitment of Participants 
Publication Details   Nil. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After obtaining institutional ethics committee approval and patients informed consent,patient aged between 18- 65 years, satisfying the inclusion criteria will be enrolled to the study. Patients will be randomized into 2 groups by computer generated random numbers as,

v  Group MAC/MIL  and

v  Group  MIL/MAC. 

Following a pre-operative evaluation patients will be kept nil per orally for 6 hours for solids and 3 hours for clear fluids, tablet Ranitidine 150 mg and tablet Ondensetron 4 mg orally with a small sip of water on the morning of surgery. Intravenous access will be secured by IV  cannulation and patient shifted to operation theatre.

Standard monitors likeelectrocardiogram(ECG) lead II, oxygen saturation (SpO2), non-invasive blood pressure (NIBP) will be attached.  Airway assessment once again will be carried out using Mallampatti classification.

The patient will be put in neutral position.The patient will be pre-oxygenated with 100% oxygen for 3 minutes. Anaesthesia will be  induced with 2 mg/ kg of propofol, fentanyl 2 µg/ kg. Feasibility of ventilation with a face mask will be checked prior to injection of  muscle relaxant. After ventilation was confirmed, inj. Atracurrium 0.5mg/kg  willbeadministered and the patient will be ventilated with Iso-flurane 0.5-1% till TOF 0/1.

In the MAC/ MIL group, initial laryngoscopic grading with a Macintosh blade will be noted and then with the Miller blade and vice versa in the MIL/ MAC group. The Macintosh blade will be advanced along the right surface of the tongue and the Miller blade will be advanced along the central surface of the tongue, the tips of both blades being placed in the vallecula. Cook’s modification of CORMACK and LEAHANE grading of the laryngoscopic views will be noted. Optimal external laryngeal manipulation (OELM) will be performed by the laryngoscopist if the grading2a or more and an improvement in laryngoscopic grading will be noted. Following each laryngoscopic attempt, an adequate depth of anaesthesia will be maintained. The patients will be intubated after the second laryngoscopic attempt irrespective of the type of blade. Ease of intubation will be graded as follows,

Ease of intubation grading:

Grade I: Intubation easy

Grade II: Intubation requiring an increased anterior lifting force and assistance to pull the right corner of the mouth upwards to increase space.

Grade III: Intubation requiring multiple attempts

Grade IV: Failure to intubate with assigned laryngoscope .

Visualization of laryngeal inlet (modified CORMACK and LEHANE Grading)

Grade 1: (full view of the vocal cords)

Grade 2A: (partial view of the vocal cords),

Grade 2B: (only the arytenoids and epiglottis seen),

Grade 3: (only epiglottis visible) and

Grade 4: (neither the epiglottis nor glottis seen).

Haemodynamical changes in the patient like NIBP, MAP, SPO2, heart rate, will be documented before induction of anaesthesia, after Induction of anesthesia but before first laryngoscopy,after first laryngoscopy, after second laryngoscopy and 5,10 and 15 minutes after intubation.

Time required for laryngoscopy to view glottis is noted with each blade. The time will begin from insertion of the laryngoscope into the mouth till first glottis view is obtained,

At the end of surgery all patients will receive inj.Ondensteron 4 mg for prevention of post-operative nausea and vomiting, Residual neuro-muscular blockade will be antagonized by inj. Neostigmine 0.05 mg/ kg and inj. Glycopyrrolate 0.01 mg/ kg and extubated once extubation criteria is met.

 
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