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CTRI Number  CTRI/2022/10/046854 [Registered on: 27/10/2022] Trial Registered Prospectively
Last Modified On: 26/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two devices used during general anesthesia 
Scientific Title of Study   Comparison of intubation characteristics of King Vision video laryngoscope vs C-Mac video laryngoscope for nasotracheal intubation- A randomised controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jerome Kumar R 
Designation  First year postgraduate student 
Affiliation  St.Johns Medical college and hospital, Bengaluru-560034. 
Address  Dept. of Anesthesiology, Second floor OT complex, St.Johns Medical college and hospital, Bengaluru-560034.

Bangalore
KARNATAKA
560034
India 
Phone  7402055868  
Fax    
Email  jeromekumar.r95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surbhi Gupta 
Designation  Professor 
Affiliation  St.Johns Medical college and hospital, Bengaluru-560034. 
Address  Dept. of Anesthesiology, Second floor OT complex, St.Johns Medical college and hospital, Bengaluru-560034.

Bangalore
KARNATAKA
560034
India 
Phone  9880109361  
Fax    
Email  surbhi_pg@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surbhi Gupta 
Designation  Professor 
Affiliation  St.Johns Medical college and hospital, Bengaluru-560034. 
Address  Dept. of Anesthesiology, Second floor OT complex, St.Johns Medical college and hospital, Bengaluru-560034.

Koppal
KARNATAKA
560034
India 
Phone  9880109361  
Fax    
Email  surbhi_pg@yahoo.com  
 
Source of Monetary or Material Support  
Dept. of anesthesiology,St.Johns medical college and hospital,Bengaluru. 
 
Primary Sponsor  
Name  Jerome Kumar R 
Address  Dept. of Anesthesiology, Second floor OT complex, St.Johns Medical college and hospital, Bengaluru-560034. 
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 
Jerome Kumar R  St Johns Medical college and hospital  Second floor OT complex, Department of Anesthesiology, St Johns medical college and hospital, Sarjapur road, Bengaluru-560034
Bangalore
KARNATAKA 
7402055868

jeromekumar.r95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, St.Johns medical college, Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C-Mac videolaryngoscope  Time for nasotracheal intubation 
Comparator Agent  Non channeled King vision videolaryngoscope  Time for nasotracheal intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists physical status(ASA) grade 1 and 2 patients scheduled for elective or emergency maxillofacial or oral cavity surgeries requiring nasotracheal intubation. 
 
ExclusionCriteria 
Details  1.Anticipated difficult endotracheal intubation (Mallampati score IV and thyromental distance of ≤6.0cm)
2.Coagulopathy
3.A history of nasal deformity, obstructive sleep apnoea, recurrent epistaxis, nasopharyngeal abnormality or surgery
4.Severe obesity (body mass index [BMI] ≥35kg/m2)
5.Cervical spine instability/pathology or cervical myelopathy
6.Pregnancy
7.Neck mass
8.Gastro oesophageal reflux disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time taken for nasotracheal intubation  T1–Time taken to pass endotracheal tube from nose into oropharynx
T2–Time taken to pass endotracheal tube from oropharynx into glottic inlet
T3–Time taken to pass endotracheal tube from glottic inlet to observation of first capnographic trace 
 
Secondary Outcome  
Outcome  TimePoints 
Glottic view as percentage of glottis opening (POGO) score  At the time of laryngoscopy 
Modified nasal intubation-difficulty scale (NIDS) rating  At the time of laryngoscopy 
Complications in the two groups  At the time of glottic visualization,
1 and 3 minutes after intubation 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   01/11/2022 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

COMPARISON OF INTUBATION CHARACTERISTICS OF KING VISION VIDEO LARYNGOSCOPE VS C-MAC VIDEOLARYNGOSCOPE FOR NASOTRACHEAL INTUBATION – A RANDOMISED CONTROLLED STUDY

Nasotracheal intubation is essential to provide surgical access in patients who are undergoing oral and maxillofacial surgeries. Nasotracheal intubation is more challenging than orotracheal intubation due to the difficulty in advancing the tip of the endotracheal tube into the trachea.Video laryngoscopes aid in visualisation of the vocal cords without the need to align the oral, pharyngeal, and tracheal axes hence facilitating intubation. This study will be done to compare C-MAC D-blade video laryngoscope to non-channelled King Vision video laryngoscope for nasotracheal intubation. This study will include 86 ASA -1 and ASA-2 patients aged between 18 to 59 years undergoing maxillofacial or oral cavity surgery requiring nasotracheal intubation. Patients will be divided into 2 groups (43 each) randomly via computer generated sequence. A detailed preanesthetic evaluation and all the relevant investigations will be done. On arrival in OT, standard ASA monitors will be attached and all patients will be premedicated using 0.02 mg/kg midazolam, 0.2mg glycopyrrolate, 4mg ondansetron and 2mcg/kg fentanyl intravenously. All the patients will be preoxygenated with 100% oxygen for 3 minutes. Standard induction will be with Inj. Propofol 1.5-2mg/kg intravenously and Inj. Atracurium 0.5 mg/kg intravenously for muscle relaxation. Isoflurane will be used as the inhalational agent. Nasotracheal intubation will be performed with appropriately sized RAE(Ring-Adair-Elwin) endotracheal tube by an experienced anaesthesiologist.The primary outcome variable will be total intubation time calculated from the beginning of introduction of the RAE endotracheal tube in the nostril till the appearance of the first end‑tidal carbon dioxide waveform(capnography). This will include time required for insertion of the ETT in each of three intubation steps (from nose into oropharynx(T1), from oropharynx into glottic inlet(T2), and from glottic inlet to observation of first capnographic trace(T3)). The time taken will be noted by the Primary investigator using a stopwatch. The secondary outcomes will be comparing glottic view as percentage of glottis opening (POGO) score, modified nasal intubation difficulty score (NIDS) and complications related to NTI. Data collected will be collected and will be tabulated for statistical analysis.   

 
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