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CTRI Number  CTRI/2019/03/018078 [Registered on: 13/03/2019] Trial Registered Prospectively
Last Modified On: 12/03/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of ease of placement of two different types of tubes in the windpipe using a video equipped instrument  
Scientific Title of Study   Comparison of polyvinyl chloride(PVC)and curved reinforced endotracheal tubes(CRT) for tracheal intubation using channeled kingvision videolaryngoscope: A randomized controlled study 
Trial Acronym  PVCCRT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surbhi Gupta 
Designation  Associate Professor 
Affiliation  St. Johns Medical College and Hospital 
Address  Department of Anesthesia and Critical Care St. Johns Medical College and Hospital Sarjapur road Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9880109361  
Fax    
Email  surbhi_pg@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surbhi Gupta 
Designation  Associate Professor 
Affiliation  St. Johns Medical College and Hospital 
Address  Department of Anesthesia and Critical Care St. Johns Medical College and Hospital Sarjapur road Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9880109361  
Fax    
Email  surbhi_pg@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrMManjuladevi 
Designation  Associate Professor 
Affiliation  St. Johns Medical College and Hospital 
Address  Department of Anesthesia and Critical Care St. Johns Medical College and Hospital Sarjapur road Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9449059395  
Fax    
Email  drmanjula95@yahoo.com  
 
Source of Monetary or Material Support  
St. Johns Medical college and Hospital Sarjapur road Bengaluru-560034  
 
Primary Sponsor  
Name  Dr Surbhi Gupta 
Address  Department of Anesthesia and Critical care St. Johns Medical College and Hospital Sarjapur road 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 
Dr Surbhi Gupta  Operation Theatre room 2nd floor OT complex Department of Anesthesia   St. Johns Medical College and Hospital Sarjapur road Bengaluru-560034
Bangalore
KARNATAKA 
080-22065511

surbhi_pg@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St. Johns Medical College and Hospital, Sarjapur road, Bengaluru-560034  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curved reinforced (CRT) endotracheal tube  Curved reinforced (CRT) endotracheal tube will be used to intubate the trachea of patients receiving general anesthesia 
Comparator Agent  Polyvinyl Chloride (PVC) endotracheal tube  Polyvinyl Chloride (PVC) endotracheal tube will be used to intubate the trachea of patients receiving general anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients scheduled for elective/ emergency surgery under general anesthesia with endotracheal intubation 
 
ExclusionCriteria 
Details  1.Patient refusal
2.Patients with anticipated difficult airway
3.Patients with potentially full stomach with risk of gastric regurgitation
4.Pregnant patients
5.Morbid obesity
6.History suggestive of acid peptic disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare time of intubation of CRT and PVC endotracheal tube through kingvision videolaryngoscope during general anesthesia.  T1-Time from insertion of videolaryngoscope in the mouth to optimal glottis view.
T2-Time from obtaining an optimal glottis view to visual confirmation of ETT passing through glottis
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare
a)ease of intubation
b) optimization maneuvers
c) airway adjuncts used
d)complications between the two groups

 
T3-Time of intubation
T4-Imediate postoperative period at 30min 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/03/2019 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1.Ali QE, Amir SH, Ahmad S. A comparative evaluation of King Vision video laryngoscope (channelled blade), McCoy, and Macintosh laryngoscopes for tracheal intubation in patients with immobilized cervical spine. Sri Lankan Journal of Anaesthesiology: 25(2):70-75(2017) 2.Minonishi T, Kinoshita H, Tange K, Hatakeyama N, Matsuda N, Azma T, et al. Tracheal intubation with the AirwayScopeâ„¢ videolaryngoscope using straight vs curved reinforced tubes. Can J Anaesth. 2010; 57:92–3  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

General anesthesia with endotracheal intubation requires insertion of a tube in the trachea by laryngoscopy for ventilation of the lungs. Standard polyvinyl chloride(PVC) tubes are routinely used for tracheal intubation, are stiffer and have a preformed curvature. Curved reinforced endotracheal tubes(CRT) have a metal wire coil embedded in the wall of the tube shaft, are non-compressible and more flexible. These are required for certain surgeries like head and neck, neurosurgery and surgeries in the prone position when access to the airway is limited for the anesthetist and there are increased chances of kinking of the tube during surgery. 

Videolaryngoscope is a digital laryngoscope which uses indirect laryngoscopy for laryngeal visualization. It does not require alignment of the oral-pharyngeal and laryngeal axes, requires less force than used during direct laryngoscopy and has a higher success rate, especially in patients with difficult airways. Numerous studies have studied the use of videolaryngoscope aided intubations using standard PVC tubes. However, there are no studies which have compared the use of standard PVC tubes with CRT using channeled kingvision videolaryngoscope. This would be especially useful in conditions where a reinforced endotracheal tube is required for a patient with anticipated difficult intubation

This prospective, randomised study therefore aims to study the ease of intubation of trachea with curved reinforced endotracheal tubes(CRT) as compared to standard Polyvinyl Chloride (PVC) tubes using kingvision videolaryngoscope

 
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