| CTRI Number |
CTRI/2018/07/015108 [Registered on: 30/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of videolaryngoscope and intubating laryngeal mask airway for putting endotracheal tube in windpipe with stabilised head and neck in patients undergoing neck surgery. |
|
Scientific Title of Study
|
Comparison of videolaryngoscope versus intubating laryngeal mask airway for tracheal intubation with manual in-line stabilisation in patients undergoing cervical spine surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reena |
| Designation |
Post graduate |
| Affiliation |
Safdarjung Hospital |
| Address |
Depatment OF Anaesthesiology And Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College And Safdarjung Hospital, New Delhi 110029 India
New Delhi
DELHI
110029
India |
| Phone |
8130978367 |
| Fax |
8130978367 |
| Email |
reenajakhar.rj.rj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suniti Kale |
| Designation |
Consultant and Professor |
| Affiliation |
Safdarjung Hospital |
| Address |
Depatment OF Anaesthesiology And Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College And Safdarjung Hospital, New Delhi 110029 India
South
DELHI
110029
India |
| Phone |
9810287852 |
| Fax |
|
| Email |
findsuniti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reena |
| Designation |
Post graduate |
| Affiliation |
Safdarjung Hospital |
| Address |
Depatment OF Anaesthesiology And Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College And Safdarjung Hospital, New Delhi 110029 India
South
DELHI
110029
India |
| Phone |
8130978367 |
| Fax |
|
| Email |
reenajakhar.rj.rj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College And Safdarjung Hospital New Delhi |
| Address |
Depatment OF Anaesthesiology And Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College And Safdarjung Hospital, New Delhi 110029 India |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Reena |
Vardhman Mahavir Medical College And Safdarjung Hospital, New Delhi-110029 |
Depatment OF Anaesthesiology And Intensive Care, Ground floor, Main OT building.
South
DELHI |
8130978367
reenajakhar.rj.rj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Age 18-65 years, ASA grade 1,2,3, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTUBATING LARYNGEAL MASK AIRWAY. |
Patients in this group will be given general anaesthesia with Fentanyl 2 microgram/kg body weight followed by propofol2-2.5 mg/kg body weight and vecuronium bromide 0.1mg/kg body weight to facilitate endotracheal intubation. the patients head and neck will then be immobilised in neutral position using MILS. The patient will be intubated using Intubating Laryngeal Mask Airway. |
| Comparator Agent |
VIDEOLARYNGOSCOPE |
Patients in this group will be given general anaesthesia with Fentanyl 2 microgram/kg body weight followed by propofol2-2.5 mg/kg body weight and vecuronium bromide 0.1mg/kg body weight to facilitate endotracheal intubation. the patients head and neck will then be immobilised in neutral position using MILS. The patient will be intubated using CMAC D blade videolaryngoscope. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA GRADE 1,2,3
2 Patients undergoing elective cervical spine surgery requiring tracheal intubation with manual in-line stabilisation under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airwayas per the following criteria-
1 Mallampati grade 4
2 Neck circumference > 40 cm
3 Mouth opening < 4 cm
4 Upper lip bite test- class 2 and 3
- Any sweeling pathology in the oral cavity or around the neck |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Total time taken to secure the airway with tracheal tube
2 Number of attempts(1 or 2)
3 Apnea time
|
During intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Degree of head movement
2 Haemodynamic parameters
3 Mucosal or dental trauma
4 Rescue device used or not |
At the time of intubation, during surgery, post-operative period |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/01/2018 |
| 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) |
Open to Recruitment |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
1)To compare the success of intubation using videoolaryngoscope and intubating laryngeal mask airway with manual in-line stabilisation undergoing elective surgery in terms of -Total time taken to secure the airway, number of attempts of intubation and apnea time. 2)To measure the degree of head movement during intubation. 3) To measure the hemodynamic parameters and desaturation at baseline, before induction, after induction, every minute during procedure and thrn 1,3,5 mins after intubation. 4) To record any mucosal injury or dental trauma in post-operative period.
HYPOTHESIS- CMAC Videolaryngoscope provides better intubating conditions as compared to Intubating laryngeal mask airway for tracheal intubation with manual in-line stabilisation. |