| CTRI Number |
CTRI/2018/10/016006 [Registered on: 12/10/2018] Trial Registered Prospectively |
| Last Modified On: |
10/10/2018 |
| 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 intubating devices in adult patients(Tuoren Video Laryngoscope,Airtraq AND Macintosh Laryngoscope) |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMISED STUDY TO COMPARE THE EFFICACY OF TUOREN VIDEO LARYNGOSCOPE , AIRTRAQ AND MACINTOSH LARYNGOSCOPE AS INTUBATING AIDS IN ADULT PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHIT PRAKASH |
| Designation |
Junior Resident |
| Affiliation |
JNMCH AMU |
| Address |
Department of Anesthesiology and Critical Care, JNMCH, AMU, Aligarh.
B72,Pushpanjali Colony,Ramghat Road,Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897485065 |
| Fax |
|
| Email |
mohitprakashdx@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Qazi Ehsan Ali |
| Designation |
Professor |
| Affiliation |
JNMCH AMU |
| Address |
Department of Anesthesiology and Critical Care,JNMCH,AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897485065 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohit Prakash |
| Designation |
Junior Resident |
| Affiliation |
JNMCH AMU |
| Address |
Department of Anesthesiology and Critical Care ,JNMCH,AMU,Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
|
| Fax |
|
| Email |
mohitprakashdx@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, JNMCH,AMU,Aligarh. |
|
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Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical Care |
| Address |
Department of Anesthesiology and Critical Care JNMCH, AMU, Aligarh |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohit Prakash |
Jawahar lal Nehru Medical College and Hospital,Aligarh Muslim University,Aligarh. |
Department of Anesthesiology and Critical care,Jawahar lal Nehru Medical College ,Aligarh Muslim University,Aligarh.
Aligarh
UTTAR PRADESH |
9897485065
mohitprakashdx@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z13||Persons encountering health services for examinations, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Airtraq |
Optical channelled laryngoscope used for intubating patients |
| Comparator Agent |
Macintosh laryngoscope |
Conventional laryngoscope introduced in 1943. |
| Intervention |
Tuoren Video Laryngoscope |
It is a video laryngoscope used for intubating patients under vision |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II patients
Age between 20-65 years
Weight between 40-75kg
Patients of both sexes
Patients planned for elective surgery
All classes of MP grades |
|
| ExclusionCriteria |
| Details |
Previous history of multiple /failed intubation
Predicted difficult laryngoscopy
Any pathology of the oral cavity that may obstruct the insertion of device
Mouth opening less than 2.5cm
Potentially full stomach patients (trauma,morbid obesity,pregnancy,history of gastric regurgitation and heart burn)and at risk of oesophageal reflux (hiatus hernia)
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of attempts required for successful intubations |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Laryngoscopy and intubation time
Ease of tracheal intubation Glottic view using Cormack and Lehane Grading
Adjustment maneuvers required for successful intubation
Changes in heart rate and mean arterial blood pressure during laryngoscopy and intubation
Any trauma during laryngoscopy and intubation
Postoperative sore throat within 24 hrs |
1 year |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/10/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
ABSTRACT
A Prospective Randomised Study to Compare the efficacy of Tuoren video laryngoscope ,Airtraq and Macintosh laryngoscope as intubating aids in adult patients.
Mohit Prakash***, Qazi Ehsan Ali**, Syed Hussain Amir*
Department of Anesthesiology and Critical Care
JNMCH AMU Aligarh
***Presenting Author,**Professor,*Assistant Professor
INTRODUCTION Airway management is of supreme importance in any clinical situation including cardiopulmonary resuscitation, anesthesia ,emergency medicine,intensive care and first aid as it is one of the life saving measures described under the acronym ABCD.Managing a difficult airway has always been a challenging task for an Anesthesiologist,as at times it is life threatening. The curved laryngoscopic blade described by Macintosh in 1943 is the most popular device for tracheal intubation till date but its use is a difficult skill to acquire and even the most experienced Anesthesiologist may encounter difficulties in its use.So alternative techniques have been developed to assist intubation in such cases of difficult direct laryngoscopy.Video laryngoscopy is relatively recent development that improves the success of tracheal intubation. The purpose of the study is to compare the ease of intubation using Video laryngoscope(Tuoren Video laryngoscope),Optical laryngoscope(Airtraq) and Macintosh laryngoscope in elective adult surgical patients.
Materials and Methods Elective endotracheal intubation will be carried out by using Tuoren video laryngoscope,Airtraq and macintosh video laryngoscope in 30 patients in each group. Number of attempts, ease of intubation.intubation time,number of adjustment maneuvers,glottic view using Cormack Lehane Grading,changes in heart rate and mean arterial blood pressure during laryngoscopy and intubation ,any trauma during the same and incidence post operative sore throat within 24 hrs will be compared in 3 groups.
RESULT Study will be started after a few weeks.Above quoted parameters will be recorded and compared. |