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CTRI Number  CTRI/2020/12/029692 [Registered on: 09/12/2020] Trial Registered Prospectively
Last Modified On: 20/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two different techniques of nasal intubation. 
Scientific Title of Study   Comparison of Cuff Inflation and Conventional Technique for Nasotracheal Intubation using C-MAC Video Laryngoscope. A Prospective Randomised Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Kumar  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur Rajasthan 342005 India

Jodhpur
RAJASTHAN
324005
India 
Phone  9460429221  
Fax    
Email  drrakeshspmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Kumar  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur Rajasthan 342005 India

Jodhpur
RAJASTHAN
324005
India 
Phone  9460429221  
Fax    
Email  drrakeshspmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sangamala Venkata Prem Kumar 
Designation  Postgraduate Resident 
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anaesthesiology and Critical Care All India Institute of Medical Sciences Jodhpur Rajasthan 342005 India

Jodhpur
RAJASTHAN
342005
India 
Phone  8099661696  
Fax    
Email  premkumar80491@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, basni phase 2, JODHPUR, Rajasthan, India, pincode:342005. 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences  
Address  Basni Phase 2 Jodhpur 342005 
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 Rakesh Kumar   All India Institute of Medical Sciences   Department of Anaesthesiology and Critical Care,OT 3rd floor ,OPD block,Basni Phase 2,Jodhpur
Jodhpur
RAJASTHAN 		 9460429221

drrakeshspmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional technique of Nasotracheal intubation   Comparison of two different techniques Cuff inflation and conventional technique in Nasotracheal intubation  
Intervention  ET tube Cuff inflation to guide tube from oropharynx into glottis in Nasotracheal intubation till tube crossed beyond vocal cord   Comparison of two different techniques Cuff inflation and conventional technique in Nasotracheal intubation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patient scheduled for elective surgery requiring nasal intubation
2 American Society of Anaesthesiologists (ASA) physical status 1-2 
 
ExclusionCriteria 
Details  1 Patient refusal
2 known difficult Airway
3 Patient with mouth opening <2.5cm
4 Patient difficult to mask ventilate
5 History of larynx surgery or larynx radiotherapy
6 Anticipated esophago-tracheal reflux
7 mallampati view 3 or 4
8 Frequent episodes of epistaxis or bleeding tendency
9 patients with significant systemic disease
10 Patient having Contraindications for NTI 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome of our study is Time taken for ETT placement(defined as time taken after the confirmation of tip of endotracheal tube in nasopharynx by C-MAC video laryngoscope to the appearance of three successive end tidal CO2 waveforms.  Primary outcome of our study is Time taken for ETT placement(defined as time taken after the confirmation of tip of endotracheal tube in nasopharynx by C-MAC video laryngoscope to the appearance of three successive end tidal CO2 waveforms by the end of 1 minute, beyond one minute attempt is considered a failure. 
 
Secondary Outcome  
Outcome  TimePoints 
1 Type and number of manoeuvres (M1-M4) used
2 Hemodynamic response to intubation
3 Complication if any 		 Hemodynamic parameters SpO2,HR and BP measured at pre-op,1,2,3,4,5,10,15 minutes after intubation 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/01/2021 
Date of Study Completion (India) 08/09/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Surgical procedure involving head and neck region, intraoral, maxillofacial and dental procedures usually mandate nasotracheal intubation (NTI). Advantage of NTI is that it better isolates surgical field from artificial airway so that the endotracheal tube is less vulnerable to kinking, damage due to surgical instrumentations. In addition, postoperatively nasal tube is better tolerated than the oral route and require less sedation. Nasotracheal intubation involve passing of tube through one of the nostril till the tube reaches nasopharynx and then with help of video or macintosh laryngoscope it is guided through vocal cord by various manoeuvres like burp, neck movement, tube rotation, use of bougie or by using Magill’s forceps. These manoeuvres lead to longer intubation time, trauma, bleeding of nasopharyngeal wall and hemodynamic stress response while negotiating the tube into trachea. 
Cuff inflation technique (wherein the cuff of ET tube is inflated with air) in which after inflation of the cuff  the endotracheal tube is lifted away from the posterior pharyngeal wall and gets aligned with the laryngeal inlet  and  tip of the tracheal tube is engaged with  the glottis opening. Once the tip of tube passes through the glottis, cuff is deflated and tube is further advanced. 
Cuff inflation technique has not been compared with conventional technique yet. Hence, we plan to compare these two techniques of nasal intubation. We hypothesize that cuff inflation technique will have faster intubation time and less manipulation in comparison to conventional nasal intubation technique.

 
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