| CTRI Number |
CTRI/2024/01/061568 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In Patients undergoing one lung ventilation can glidescope reduce time taken for DLT intubation as compared to king visionvideolaryngoscope or macintosh |
|
Scientific Title of Study
|
COMPARISON OF GLIDESCOPE, KINGVISION VIDEOLARYNGOSCOPE(nonchannelled) AND MACINTOSH LARYNGOSCOPE FOR DOUBLE LUMEN TUBE INSERTION IN PATIENTS UNDERGOING ONE LUNG VENTILATION- A RANDOMIZED CLINICAL 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 |
Geetika Kir |
| Designation |
Post graduate student |
| Affiliation |
Dr SN Medical College |
| Address |
Department of anaesthesiology and critical care,Dr SN MEDICAL COLLEGE , JODHPUR RAJASTHAN,342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9915774633 |
| Fax |
|
| Email |
geetikakir10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Karnawat |
| Designation |
Senior Professor |
| Affiliation |
Dr SN Medical college |
| Address |
Department of anaesthesiology and critical care,Dr SN MEDICAL COLLEGE , JODHPUR RAJASTHAN,342001
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9828033321 |
| Fax |
|
| Email |
dr.rakeshkarnawat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Karnawat |
| Designation |
Senior Professor |
| Affiliation |
Dr SN Medical college |
| Address |
Department of anaesthesiology and critical care,Dr SN MEDICAL COLLEGE , JODHPUR RAJASTHAN,342001
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9828033321 |
| Fax |
|
| Email |
dr.rakeshkarnawat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr SN MEDICAL COLLEGE JODHPUR |
|
|
Primary Sponsor
|
| Name |
DR Sampurnanand Medical College |
| Address |
DR Sampurnanand Medical College, Residency Road, Sector -D, Shastri Nagar, Jodhpur, Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Geetika Kir |
MDM HOSPITAL JODHPUR |
Cardiothoracic operation theatre,MDM Hospital,Dr Sampurananad Medical College, Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
9915774633
geetikakir10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, DR SAMPURNANAND MEDICAL COLLEGE, JODHPUR |
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 |
Insertion of DLT using Glidescope |
DLT insertion will be done in patients undergoing one lung ventilation using a glidescope with macintosh blade and time taken to intubate will be measured |
| Comparator Agent |
insertion of DLT using Kingvision videolaryngoscope and macintosh laryngoscope |
DLT will be inserted in patients undergoing one lung ventilation using Kingvision videolaryngoscope and Macintosh laryngoscope and time taken to intubate with them as compared to glidescope will be measured |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients with American Society of Anaesthesiology physical status I or II of either sex, aged between 18 and 60 years and body mass index between 20 – 35 kg/m2, presenting for elective surgery under General Anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
1)Potential risk of regurgitation (patients
diagnosed with GERD)
2) Pregnancy
3) Patients with an anticipated difficult airway
(Mallampati Grade III and IV and mouth opening
less than 2 finger-breadth)
4) Suspected cervical spine injury and neck
instability.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation Time |
After the induction of anaesthesia the time when the blade tip will pass the incisors to the point until confirmation of the first 4 waves of EtCO2 of the capnography on the monitor. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of laryngoscopic attempts (1/2/3) |
5 mins |
| First pass success rate (in percentage) |
2 mins |
| Cormack & Lehane grade |
time between insertion of laryngoscope to visualization of vocal cords |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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
|
By comparison of DLT insertion in patients requiring one lung ventilation using McIntosh laryngoscope , glidescope and kingvision (non channelled) we will see the time required for intubation |