| CTRI Number |
CTRI/2017/10/010194 [Registered on: 25/10/2017] Trial Registered Prospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
: Comparison of three instruments ( laryngoscopes) used for placing a tube in the windpipe through nose in oral surgeries. |
|
Scientific Title of Study
|
Comparison of Macintosh, McCoy and Tru view laryngoscope for bougie aided nasotracheal intubation in patients posted for oral surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
hinehabhu@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Neha Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
hinehabhu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Neha Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
hinehabhu@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sijua, Patrapada, bhubaneswar, Pin-751019 Odisha, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India |
| 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 Neha Singh |
All India Institute of Medical Sciences, Bhubaneswar |
Theatre Complex, G Block, Near Casualty, Department of Anaesthesiology, AIIMS, Bhubaneswar, Pin-751019
Khordha
Odisha
Khordha
ORISSA |
9438884045
hinehabhu@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients posted for elective oral surgeries under general anaesthesia requiring nasotracheal intubation., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Macintosh, McCoy and Tru view laryngoscope for bougie aided nasotracheal intubation. |
comparison of the devices in terms of duration of intubation and number of attempts taken for bougie aided nasotracheal intubation. |
| Comparator Agent |
Macintosh, McCoy and Tru view laryngoscope for bougie aided nasotracheal intubation. |
omparison of the devices in terms of duration of intubation and number of attempts taken for bougie aided nasotracheal intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex aged 18 – 60 years, ASA grade I-II, undergoing elective head and neck surgeries under general anaesthesia with nasotracheal intubation will be included. |
|
| ExclusionCriteria |
| Details |
ASA III and IV patients. |
|
|
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 the time taken for bougie aided nasotracheal intubation (insertion of ETT in nostril to capnograph visualization),by Macintosh, McCoy and TruView laryngoscope. |
To compare the time taken for bougie aided nasotracheal intubation (insertion of ETT in nostril to capnograph visualization),by Macintosh, McCoy and TruView laryngoscope. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the number of attempts for bougie aided nasotracheal intubation by Macintosh, McCoy and TruView laryngoscope. |
To compare the number of attempts for bougie aided nasotracheal intubation by Macintosh, McCoy and TruView laryngoscope. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2017 |
| Date of Study Completion (India) |
14/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/12/2018 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Endotracheal intubation is a must for oxygenation and ventilation in patients undergoing surgery under general anaesthesia. The advantage of McCoy and TruView laryngoscopes over conventional laryngoscope has been demonstrated in numerous studies.1,2 The McCoy laryngoscope is designed to elevate the epiglottis with its hinged tip3 and it is frequently used to facilitate tracheal intubation when the view of the glottic opening is restricted.4 The TruView (Truphatek International Ltd, Netanya, Israel) is a modified laryngoscope that expands the angular view of the larynx and adjacent structures with the help of an optical system view tube which consists of prisms and lenses, thereby facilitating intubation.5,6 However, relative efficacy of these devices for nasotracheal intubation have not been evaluated. Therefore, this randomized, prospective study is planned to compare the effectiveness of Macintosh, McCoy and TruView laryngoscopes for bougie aided nasotracheal intubation in patients undergoing head and neck surgeries. |