CTRI Number |
CTRI/2019/09/021358 [Registered on: 20/09/2019] Trial Registered Prospectively |
Last Modified On: |
21/07/2020 |
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
|
Comparative evaluation of ease of orotracheal intubation using two different video laryngoscopes in patients undergoing elective surgeries |
Scientific Title of Study
|
“COMPARATIVE EVALUATION OF EASE OF OROTRACHEAL INTUBATION USING C-MAC® VIDEO LARYNGOSCOPE VERSUS McGRATH®MAC VIDEO LARYNGOSCOPE IN PATIENTS UNDERGOING ELECTIVE SURGERIESâ€
A PROSPECTIVE RANDOMIZED STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Anil Kumar Thakur |
Designation |
Professor and HOD Anaesthesia |
Affiliation |
ESI PGIMSR and Hospital |
Address |
Department of Anaesthesia
ESI PGIMSR and Hospital
Basaidarapur
New Delhi-110015
North East DELHI 110015 India |
Phone |
9355341868 |
Fax |
|
Email |
dranilthakur@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rafia Khan |
Designation |
Post Graduate |
Affiliation |
ESI PGIMSR and Hospital |
Address |
ESI PGIMSR and Hospital
Basaidarapur
New Delhi-110015
North East DELHI 110015 India |
Phone |
9899940679 |
Fax |
|
Email |
khanrafia40@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rafia Khan |
Designation |
Post Graduate |
Affiliation |
ESI PGIMSR and Hospital |
Address |
ESI PGIMSR and Hospital
Basaidarapur
New Delhi-110015
North East DELHI 110015 India |
Phone |
9899940679 |
Fax |
|
Email |
khanrafia40@gmail.com |
|
Source of Monetary or Material Support
|
Institutional
Guru Gobind Singh Indraprastha University
New Delhi |
|
Primary Sponsor
|
Name |
Institutional ESI PGIMSR and Hospital |
Address |
ESI PGIMSR and Hospital
Basaidarapur
New Delhi-110015 |
Type of Sponsor |
Research institution and hospital |
|
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 Rafia Khan |
ESI PGIMSR and Hospital |
2nd floor OT complex,
Department of Anaesthesia North East DELHI |
9899940679
khanrafia40@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, ESI-Post Graduate Institute of Medical Sciences and Research,Basaidarapur,NewDelhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Both male and female aged between 18 years to 60 years of age posted for elective surgery under general anaesthesia |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
C Mac video Laryngoscope |
Direct Laryngoscopy shall be done using the C MAc video laryngoscope |
Comparator Agent |
McGRATH® MAC video laryngoscope |
Direct Laryngoscopy shall be done using the Mc Grath Laryngoscope |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
INCLUSION CRITERIA
Patients with
ASA grade I / II
Age 18-60 years of either sex
Patient undergoing elective surgeries requiring general anaesthesia and orotracheal
intubation
|
|
ExclusionCriteria |
Details |
EXCLUSION CRITERIA
Patient refusal.
Patients having:
Modified Mallampatti class III or IV
Mouth opening < 2.5cm
Interincisor distance < 3.5 cm
Thyromental distance < 6 cm
Sterno-mental distance < 12 cm
Mandibulo-hyoid distance < 4 cm
Cervical spine instability
BMI >30 kg/m2
Risk of gastric aspiration
Edentulous patients and patients having artificial denture will be excluded from the study
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Ease of orotracheal tube placement using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope. |
Time (in seconds) to intubate the trachea, starting from picking up the video laryngoscope
to successful placement of endotracheal tube as confirmed by auscultation of breath sounds, and
presence of square wave capnography on monitor will be noted. If more than one intubation attempt is required, time from insertion of the laryngoscope for the first intubation attempt until confirmation of successful intubation by capnography will be considered to be the total intubation time. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Time (in seconds) taken for orotracheal intubation using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.
2.Hemodynamic effects and oxygen saturation changes during orotracheal intubation using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.
3.Complication/s (if any)
|
1 min, 3 min, 5 min, 7 min and 10 min |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
03/10/2019 |
Date of Study Completion (India) |
30/06/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Airway management is one of the most important skills in the field of anaesthesiology. Endotracheal intubation with the help of Macintosh laryngoscope is a gold standard for definitive airway management in patients undergoing surgery requiring general anesthesia.In recent years, video laryngoscopes have gained in popularity. Video laryngoscopy-assisted tracheal intubation has extensively been applied in airway management because of several significant advantages. These include:(1) improved laryngeal visualization without the need for aligning three axes (oral, pharyngeal and laryngeal axes) especially in difficult airway conditions. (2) The high-quality, magnified airway image makes it easy to identify the airway anatomical structures and anomalies, and facilitates manipulation of airway devices. (3) The entire team can see laryngoscopy and intubation process on the monitor, rather than only the intubator. The multi-person visualization feature can facilitate communication and cohesion of team, improve coordination between intubator and assistant. Non-handle mounted video laryngoscope, that is, C-MAC® video laryngoscope was developed and manufactured by the Karl Storz GmbH & Co. KG (Tuttlingen, Germany) in 1999. Handle mounted video laryngoscope, that is, McGRATH® MAC (Aircraft Medical Edinburgh, Scotland) is a novel, self-contained video laryngoscope, containing a sterile, transparent, single-use blade. The video laryngoscope was originally designed as a device to manage difficult intubation with direct laryngoscopy. Success with the application of any device can be enhanced as experience with the intervention accumulates. If video laryngoscopy is used for all patients, experience and skill would undoubtedly increase, the number of intubation attempts and complications of multiple attempts would decrease, and patient care would improve. It has been suggested that optimal video laryngoscope should be offered to all patients without significant limitations and not restricted to only those considered most difficult.As video laryngoscopes are introduced into clinical practice, it is important to evaluate their clinical performance and safety to establish superiority or equivalence to already existing devices.There are few published studies with regard to comparison of C-MAC® video laryngoscope (non-handle mounted video laryngoscope) and McGRATH® MAC video laryngoscope (handle mounted video laryngoscope) around the world but no such study has been conducted in India. Hence, this study is planned to be conducted in a prospective, randomized manner to compare C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope for their use in patients undergoing elective surgery under general anesthesia in adult Indian population. |