| CTRI Number |
CTRI/2019/01/017143 [Registered on: 17/01/2019] Trial Registered Prospectively |
| Last Modified On: |
14/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two different laryngoscopes(Truview and C-MAC) for making intubation through the nares easier with the head in neutral position. |
|
Scientific Title of Study
|
A Randomized controlled study on ease of nasotracheal intubation comparing Truview laryngoscope and C-MAC video laryngoscope in a simulated cervical spine immobilization |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogalakshmi K |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room No 22, SRM Medical College Hospital and Research Centre, Kattankulathur 603203, Kancheepuram district
SRM Medical College Hospital and Research Centre, Potheri,kattangulathur, Kancheepuram district 603203
Chennai
TAMIL NADU
603203
India |
| Phone |
9600117758 |
| Fax |
|
| Email |
yogalakshmiyoyo@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balaji R |
| Designation |
Associate professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room No 214, Department of Anaesthesiology, SRM Medical College Hospital and Research Centre, Kattankulathur 603203, Kancheepuram
SRM Nagar, Potheri,kattangulathur, Kancheepuram district 603203
Chennai
TAMIL NADU
603203
India |
| Phone |
9677053310 |
| Fax |
|
| Email |
aarbee79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogalakshmi K |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room No 22, Department of Anaesthesiology, SRM Medical College Hospital and Research Centre, Kattankulathur 603203, Kancheepuram
SRM Nagar, Potheri,kattangulathur, Kancheepuram district 603203
Chennai
TAMIL NADU
600100
India |
| Phone |
9600117758 |
| Fax |
|
| Email |
yogalakshmiyoyo@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, Room No 209, Department of Anaesthesiology, kattangulathur 603203, Kancheepuram |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Institute |
| Address |
SRM Nagar, Potheri, Kattankulathur -603203, Kancheepuram district. |
| 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 K Yogalakshmi |
SRM Medical college Hospital and Research institute |
Room No 209, Department of anaesthesia,SRMIST, Potheri, Kancheepuram district 603203
Kancheepuram
TAMIL NADU |
9600117758
yogalakshmiyoyo@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
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 |
| Comparator Agent |
C MAC laryngoscope |
Video laryngoscope for visualisation of glottic structure, time to intubate, ease of intubation and incidence of airway trauma. |
| Intervention |
Truview laryngoscope |
Use Truview laryngoscope to visualise glottic structure, time to intubate, ease of intubation and incidence of airway trauma. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I-II .
Mallampatti class 1&2
Surgery done under general anaesthesia requiring nasotracheal intubation.
|
|
| ExclusionCriteria |
| Details |
Patients who refuse the study
Patient with known allergies to the study drugs
ASA>2, Mallampatti class 3&4
Difficult airway
Emergency procedures
Pregnancy
Patients with coagulation abnormalities.
Patients with fractures involving base of skull.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Visualization of the glottic structures-Cormack Lehane grading
2. Ease of intubation.
3. Intubation time.
|
Time in seconds from inserting the laryngoscope into the oral cavity to visual confirmation of tracheal tube passing through the glottic aperture. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of airway trauma |
From laryngoscopy to 24hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/01/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After Institutional Ethical Committee approval, 100 patients will be enrolled ion the study. Patients will be allotted into two groups(Group C for CMAC and Group T for Truview). All the patients will be premeditated with glycopyrrolate 4mcg/kg, midazolam 10mcg/kg , ondansetron 0.15mg/kg, fentanyl 2mg/kg. Patients will be induced with propofol 2mg/kg and neuro muscular blocking agent vecuronium 0.1mg/kg. Patients will be ventilated with oxygen and nitrous oxide (1:1 ratio) and sevoflurane 2% for initial 4mins, followed by ventilation with 100% oxygen for 1 mins before intubation. Manual inline stabilisation will be applied by the investigator to simulate difficult intubation scenario and the patients will be intubated nasotracheally using either of the laryngoscope. Time taken for intubation will be noted. Patients will be followed up for 24hrs post extubation. |