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CTRI Number  CTRI/2024/12/078399 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 19/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the procedure of inserting tube into mouth for general anaesthesia cases using the 3 types of generally used equipment namely Videolaryngoscope, McCoy laryngoscope and Intubating Laryngeal Mask Airway for doing oral intubation that is putting tube through with neck in neutral position 
Scientific Title of Study   Comparison of Videolaryngoscope, McCoy laryngoscope and Intubating Laryngeal Mask Airway for oro-tracheal intubation in simulated cervical spine immobilization: A Prospective Randomized Comparative 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 K B Nalini 
Designation  Associate Professor 
Affiliation  SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  operation theatre, ground floor, department of anaesthesiology SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE

Bangalore
KARNATAKA
560001
India 
Phone  7760594547  
Fax    
Email  dr_kbnalini@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K B Nalini 
Designation  Associate Professor 
Affiliation  SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  operation theatre, ground floor, department of anaesthesiology SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE

Bangalore
KARNATAKA
560001
India 
Phone  7760594547  
Fax    
Email  dr_kbnalini@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr K B Nalini 
Designation  Associate Professor 
Affiliation  SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  operation theatre, ground floor, department of anaesthesiology SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE

Bangalore
KARNATAKA
560001
India 
Phone  7760594547  
Fax    
Email  dr_kbnalini@yahoo.com  
 
Source of Monetary or Material Support  
SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH, INSTITUTE, shivajinagar, bangalore karnataka - 560001 
 
Primary Sponsor  
Name  dr manoj dean and director 
Address  SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE, shivajinagar, bangalore, karnataka - 560001 
Type of Sponsor  Government 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 k b nalini  operation theatre  SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE, shivajinagar,
Bangalore
KARNATAKA 
7760594547

dr_kbnalini@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethical committee of SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE AND RESEARCH INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patients posted for surgeries under general anaesthesia 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intubating Laryngeal Mask Airway   comparing the intubation  
Intervention  McCoy laryngoscope   comparing intubation details  
Comparator Agent  Videolaryngoscope   comparing intubation details  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status classes I or II,scheduled for elective surgery under general anesthesia with endotracheal intubation.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to measure intubation success rate.
Ease and success of oral endotracheal intubation were assessed by: a. number of attempts taken, max 2 attempts allowed b.Time taken for intubation c. Need for laryngeal maneuvers or stylet or bougie.  
o, 1, 3, 5 , 10 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters during the intubation procedure (baseline, preintubation, 1, 3, 5mins after intubation) b.   1, 3, 5 mins interval 
b. incidence of desaturation   1, 3, 5 mins 
Postoperative complications - Incidence of postoperative sore throat (1hr postoperative period) and Incidence of injury to teeth and other soft tissues.  end operative post extubation 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   30/12/2024 
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="3"
Days="20" 
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  

All the patients will be kept nil per oral overnight andpremedicated with tablet pantoprazole 40 mg and tab ondansetron 4mg orally 2hrs prior to the surgery. In the operation theater, electrocardiogram, noninvasive blood pressure, and pulse oximeter will be attached and baseline readings will be noted. An adequate gauge intravenous (i.v.) cannula will be secured and i.v. fluid started. The patient will bepreoxygenated with 100% oxygen for 3 min. General anesthesia will be induced with fentanyl 2 µg.kg −1 body weight followed by propofol 2–2.5 mg.kg −1 body weight and vecuronium bromide 0.1 mg.kg −1 body weight to facilitate endotracheal intubation. Mask ventilation will be done with oxygen (FiO2 1) and isoflurane (MAC 0.6). Patient’s head and neck will be immobilized in the neutral position using appropriate size rigid Philadelphia cervical collar. [3]

After 3 min, oral intubation will be performed using the assigned device by anexperienced anesthesiologist, who has conducted at least 100 successful intubations using these devices.

As per group allocation intubation will be performed using one of the three devices. In group VL, blade will be inserted in the midline in the oral cavity and advanced under its monitor vision till its tip reached vallecula. The epiglottis is then lifted to visualize the glottic opening. A cuffed reinforced endotracheal tube (ETT) of internal diameter 7.0–7.5 mm for females and 8.0-8.5 mm for males will be introduced. Correct placement of ETT is confirmed by the appearance of square wave capnographic trace, bilateral equal breath sounds, and absence of epigastric sounds.

In group MC, MAC COY blade will be inserted in the midline in the oral cavity and advanced till its tip reached vallecula. The epiglottis is then lifted to visualize the glottic opening. A cuffed reinforced endotracheal tube (ETT) of internal diameter 7.0–7.5 mm for females and 8.0-8.5 mm for males will be introduced.

Stylet or bougie will be used for intubation if needed in the above two groups, and will be noted.

In group IL, the correct size of ILMA will be selected according to patient’s body weight: 30–50 kg: ILMA number 3, ILMA tube 7.0 mm; 50–80 kg: ILMA number 4, ILMA tube 7.5 mm. The cuff of ILMA is partially deflated using deflator and upper surface of its mask is lubricated. Mouth is opened using nondominant hand and ILMA inserted by dominant hand. The cuff of ILMA is inflated with the requisite amount of air (size 3: 20 ml, size 4: 40 ml, and size 4: 50 ml) and adjusted to get optimal ventilation. [6] After confirming the presence of bilateral equal entry and a square wave capnograph, intubation will be done with lubricated ILMA ETT. The cuff of ILMA ETT is inflated and intubation confirmed by visualizing square wave capnograph and bilateral air entry. The ILMA cuff is deflated, and ILMA is swung out of the pharynx into the oral cavity while applying counter pressure to the tracheal tube using the stabilizing rod. The ETT connector is replaced and tube placement reconfirmed using a square wave capnograph. Either of the following maneuvers is used for troubleshooting any difficulty in intubation through the ILMA: rotation of ILMA ETT, reinsertion of ILMA ETT, and reinsertion of ILMA of same or smaller or larger size. [6]

Hypoxemia is defined as fall in SpO2 up to or below 92%. In case of failure to intubate with the given device in any of the group within two attempts, patient’s trachea is intubated using macintosh laryngoscope after removing the cervical collar and will be excluded from the study. After rechecking the ETT position, patient is ventilated mechanically, and anesthesia will be maintained with isoflurane (0.6–0.8 MAC) in oxygen and nitrous oxide (FiO2 0.4). 
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