| CTRI Number |
CTRI/2024/12/077582 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [a prospective randomised open labelled study] |
| Study Design |
Other |
|
Public Title of Study
|
to compare two different methods of endotracheal intubation with cmac videolaryngoscopy and to know which method is easier |
|
Scientific Title of Study
|
Comparison of ease of endotracheal intubation with direct elevation of epiglottis versus conventional method using CMAC videolaryngoscopy-A prospective randomised study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
koppolu suchitra |
| Designation |
MBBS,post graduation (MD)Anaesthesiology |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology,SVIMS,Alipiri,Chittoor district,517507,
Andhra pradesh,INDIA
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9966492496 |
| Fax |
|
| Email |
ksuchitra385@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.p.Hemalatha |
| Designation |
professor,Department of anaesthesiology |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology,SVIMS,Alipiri,Chittoor district,517507,
Andhra pradesh,INDIA
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9966492496 |
| Fax |
|
| Email |
madhugastro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
koppolu suchitra |
| Designation |
MBBS,post graduation (MD)Anaesthesiology |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Department of Anaesthesiology,SVIMS,Alipiri,Chittoor district,517507,
Andhra pradesh,INDIA
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9966492496 |
| Fax |
|
| Email |
ksuchitra385@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venkateswara institute of medical sciences,Titupathi,Chittoor district,517507,Andhrapradhesh,INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 P Hemalatha |
Sri Venkateswara Institute of Medical sciences |
Dept of Anaesthesiology
Sri venkateswara institute of medical sciences
Tirupathi
Chittoor
ANDHRA PRADESH |
9493547660
madhugastro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee SVIMS Tirupathi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Direct elevation of epiglottis with CMAC video laryngoscopy |
Epiglottis is directly elevated with tip of C-MAC video LARYNGOSCOPY blade after induction and intubation is done |
| Comparator Agent |
direct elevation of epiglottis with CMAC video laryngoscopy for ease of intubation |
without lifting of epiglottis with CMAC video laryngoscopy for ease of intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)patients with american society of anaesthesiologists physical status 1,2,3
2)age between 18-65 years
3)patients scheduled to undergo general anaesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1)pregnants and lactating mothers
2)patients undergoing emergency surgeries
3)patients with anticipated difficult intubation
4)patients not willing to participate in the study
5)patients on drugs effecting haemodynamic parameters like antihypertensives,antiarrythymic drugs,betablockers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the ease of intubation using intubation difficulty scale score |
COMPARISON OF HAEMODYNAMIC CHANGES AT BASELINE,1MIN,3MIN,5MIN IN TWO DIFFERENT GROUPS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time to view glottis ,time for endotracheal intubation,total intubation time |
1)time to view glottis
2)time for endotracheal intubation
3)total intubation time |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Videolaryngoscopy is one of the recent advancement in laryngoscopes which combines the technology of original macintosh blade with videoscope and aid in tracheal intubation. in general during laryngoscopy blade tip is placed in vallecula and epiglottis is elevated indirectly to expose the glottis for endotracheal intubation.when indirect epiglottic elevation yields poor glottic view direct epiglottis elevation,lifting the epiglottis directly with the blade tip can be used.studies have shown significant improvement in glottis exposure with direct epiglottis elevation compared to indirect elevation of epiglottis during video laryngoscopic intubation.Hence we hypothesized that the direct epiglottis elevation will provide better glottic view and improve the ease of endotracheal intubation compared to indirect elevation using CMAC videolaryngoscopy.
|