| CTRI Number |
CTRI/2016/08/007128 [Registered on: 01/08/2016] Trial Registered Prospectively |
| Last Modified On: |
30/07/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [ANESTHESIA ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
REUSABLE LARYNGEAL TUBE SUCTION(LTS-II); STANDARD INSERTION TECHNIQUE VERSUS TWO MODIFIED INSERTION TECHNIQUES USING JAW THRUST TECHNIQUE AND MACINTOSH LARYNGOSCOPY |
|
Scientific Title of Study
|
comparison of standard insertion technique echnique to insert REUSABLE LARYNGEAL TUBE SUCTION(LTS-II)with TWO MODIFIED INSERTION TECHNIQUES USING JAW THRUST TECHNIQUE AND MACINTOSH LARYNGOSCOPY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajesh Mahajan |
| Designation |
Associate Professor |
| Affiliation |
GMC JAMMU |
| Address |
Government Medical College
Bakshi Nagar
Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419141263 |
| Fax |
|
| Email |
drmahajanr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Mahajan |
| Designation |
Associate Professor Anesthesia |
| Affiliation |
GMC JAMMU |
| Address |
Government Medical College
Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419141263 |
| Fax |
|
| Email |
drmahajanr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Mahajan |
| Designation |
Associate Professor |
| Affiliation |
GMC JAMMU |
| Address |
Government Medical College
Jammu
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419141263 |
| Fax |
|
| Email |
drmahajanr@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College
Bakshi Nagar
Jammu |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 |
| rajesh mahajan |
Operation Theatre Complex ,second and third floor, Government Medical College ,Jammu |
Department of anesthesia AND icu
Government Medical College Jammu
Bakshi Nagar
jammu
Jammu
JAMMU & KASHMIR |
09419141263
drmahajanr@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECGMC JAMMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASAI AND II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INSERTION OF LTS USING jaw thrust |
Group B The jaw thrust approach will consist of first opening the patient’s mouth by crossing the thumb and index finger of the left hand. With the remaining three fingers of the left hand, a chin lift manoeuvre (‘‘Esmarch grip’’) will be performed simultaneously to create sufficient retropharyngeal space. Then, the flat edge of the tube’s tip will be placed against the hard palate and slid along the palate in the midline down into the hypopharynx until the black marking on the LTS-D will be aligned with the upper teeth. The cuffs will be inflated with the volume indicated on the syringe, and a gastric drain tube is inserted.. The cuff pressure will be adjusted to 60cmH2O using a cuff pressure manometer (Rusch Endotest, Cuff Pressure Gauge)..If any difficulties occurred during advancement of the LTS-D, vertical and caudal traction of the mandible will be intensified with the operator’s other hand.
|
| Intervention |
INSERTION OF LTS USING LARYNGOSCOPE |
Group C ; I laryngoscope will be used. A Macintosh laryngoscope blade will be placed in vallecula and the epiglottis and esophagus will be identified, then both the tongue and epiglottis will be lifted anteriorly (superiorly). Howevr no undue force was applied to visualize the glottic aperture or scoring it .The laryngeal tube will be then inserted under vision
|
| Comparator Agent |
The standard blind insertion technique |
Group A. The standard comparative insertion technique will be performed according to the instructions for use provided by the manufacturer. The LTS-D will be held like a pen in the area of the black teeth markings. With the free hand, the mouth will be kept open and it will be ensured that the tongue will be not folded back during the downward movement of the LTS-D. Then, the flat edge of the tube’s tip will be placed against the hard palate and slid along the palate in the midline down into the hypopharynx until the black marking on the LTS-D will be aligned with the upper teeth. The cuffs were now inflated with the volume indicated on the syringe, and a gastric drain tube is inserted.. The cuff pressure will be adjusted to 60cmH2O using a cuff pressure manometer (Rusch Endotest, Cuff Pressure Gauge). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
either sex
Age 18-75 years
ASA Grade I and II,
|
|
| ExclusionCriteria |
| Details |
BMI>35kg/m2
Known airway or esophageal pathology
Patients with known or predicted difficult airway
Upper Respiratory Tract infection in previous 10days
Patients at preoperative increased risk of aspiration
Pathological conditions of upper respiratory tract or upper gastrointestinal tract
Pregnancy
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary aim of the study will be to compare the success rate of the insertion in two attempts or records it as failure by anesthesia residents
|
Starts after the placement of device and confirmation of its successful placement in two attempts insertion in two attempts or records it as failure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to place LTSII in seconds
Number of attempts needed to place
ease of insertion of device 0/1/2/3/4
attempts and grading of gastric tube insertion 0/1/2
Airway seal pressures at 10 minutes
blood or gastric secretions on the device
Any airway morbidity
Intraoperative complications
post operative complications and airway morbidity
|
time from insertion of device to successful ventilation |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/08/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil. nothing for links |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a prospective , randomized trial comparing insertion success rate of three techniques to study the insertion success rate of laryngeal tube suction -II in 144 poatients it will be done in department of Anesthesia and ICU Government Medical College , Jammu . Appropriate sized laryngeal tube suction - II will be inserted. Primary outcome will to study the success rate of three insertion techniques Secondary outcome measures will be ease of insertion of device,insertion attempts , insertion time , ease of gastric tube insertion , airway manipulations oropharyngeal seal pressures and complications, if any |