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
|
|
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
|
|
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 AirwayScope™ 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 |