| CTRI Number |
CTRI/2022/06/043121 [Registered on: 09/06/2022] Trial Registered Prospectively |
| Last Modified On: |
15/06/2022 |
| 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 Safety and Efficacy in Laryngeal Mask Airway Insertion by Blind method and Laryngoscope Guided Method |
|
Scientific Title of Study
|
Safety and Efficacy of Laryngeal Mask Airway Placement in Term of Oropharyngeal Leak Pressure : A Comparison between ConventionalInsertion and Laryngoscope Guided Insertion |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayan Kumar Ghorui |
| Designation |
Post Graduate Trainee (MD Anaesthesiology) |
| Affiliation |
Bankura Sammilani Medical College |
| Address |
Rabin Hall, Bankura Sammilani Medical College
Bankura
WEST BENGAL
722102
India |
| Phone |
8017856053 |
| Fax |
|
| Email |
ayan.bsmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Debasish Saha |
| Designation |
Professor and Head, Department of Anaesthesiology |
| Affiliation |
Bankura Sammilani Medical College |
| Address |
Bankura Sammilani Medical College and Hospital
Bankura
WEST BENGAL
722102
India |
| Phone |
9434100947 |
| Fax |
|
| Email |
drdebasishsaha1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayan Kumar Ghorui |
| Designation |
Post Graduate Trainee (MD Anaesthesiology) |
| Affiliation |
Bankura Sammilani Medical College |
| Address |
Rabin Hall, Bankura Sammilani Medical College
Bankura
WEST BENGAL
722102
India |
| Phone |
8017856053 |
| Fax |
|
| Email |
ayan.bsmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology,Bankura Sammilani Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bankura Sammilani Medical College |
| Address |
Bankura Sammilani Medical College, Kenduadihi,Bankura,West Bengal,Pin 722102 |
| 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 |
| Dr Ayan Ghorui |
Bankura Sammilani Medical College and Hospital |
Surgery Orthopedic Urology Gynaecological operation theater , under Dept of Anaesthesiology..,Bankura Sammilani Medical College and Hospital
Bankura
WEST BENGAL |
8017856053
ayan.bsmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee |
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 |
| Comparator Agent |
Laryngeal Mask Airway Placement -Laryngoscope guided |
When an appropriate depth of anaesthesia was achieved (relaxation of the jaw), the head was placed in the dorsiflexion sniffing position and a lubricated LMA was inserted using laryngoscopic guidance in Group-L.
Selection of the LMA size was based on the body weight of the patient, usually size 3 for women and size 4 for men.
Laryngoscopy was performeD by a MacIntosh #3 laryngoscope blade was placed in the vallecula and the epiglottis was identified; then, both the tongue and epiglottis were lifted anteriorly.
Total duration of LMA insertion depends on surgery,(usually between 30 min to 90 min).
|
| Intervention |
Layngeal Mask Airway placement by conventional method |
When an appropriate depth of anaesthesia was achieved (relaxation of the jaw), the head was placed in the dorsiflexion sniffing position and a lubricated LMA was inserted by conventional method (blindly) in Group-C.
Selection of the LMA size was based on the body weight of the patient, usually size 3 for women and size 4 for men.
Total duration of LMA insertion is same as before, i.e depends on surgery,(usually between 30 min to 90 min).
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Patients aged between 19-70years of each sex
• Patients belonging to ASA physical status Grade I and II.
• Patients planned for elective general surgery, urosurgery, gynae-obstetrics& orthopedic surgery under general anaesthesia with Laryngeal Mask Airway.
|
|
| ExclusionCriteria |
| Details |
• Patient not giving consent.
• Recent history of upper respiratory tract infection
• Contraindications of use of LMA such as body mass index(BMI) ≥ 40 kg/m2
• patients who are at an increased risk of gastric aspiration-the patient with a history of obesity, hiatal hernia, gastroparesis or trauma
• An inability to open the mouth or an infection or pathologic abnormality within the oral cavity or pharynx,
• Disease like-Bronchospasm, pulmonary edema
• Any acute injury or trauma patient
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OPLP, time taken for insertion, whether first attempt successful, Post LMA removal adverse events |
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters will be recorded at baseline, 1 min after anaesthesia induction, before insertion of the LMA, and 1 min after insertion of the LMA |
6 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngeal Mask Airway is most commonly used supraglottic airway devices, it is routinly used by conventional/blind technique.It can also be introduced by laryngoscope guidance.The degree of airway protection or sealing in LMA can be determine from clinical sign such as Oropharyngeal Leak PreSsure (OPLP) or Fiberoptic Scoring...Here OPLP is considering better clinical performance or function of the LMA than Fiberoptic scoring system..Higher OPLP is desirable as they indicate the feasibility of positive pressure ventilation and the likelihood of supraglottic airway placement. |