| CTRI Number |
CTRI/2023/03/051160 [Registered on: 29/03/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the comparison of video assisted intubation through LMA protector and i-gel. |
|
Scientific Title of Study
|
Comparison of fibreoptic guided tracheal intubation through LMA protector and i-gel in adult paralysed patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Bhardwaj |
| Designation |
Professor |
| Affiliation |
Pt B.D. Sharma PGIMS |
| Address |
Department of anaesthesiology and critical care
Pt B.D. Sharma PGIMS
Rohtak
Rohtak HARYANA 124001 India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drbmamta@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
M karthik |
| Designation |
Postgraduate student |
| Affiliation |
Pt B.D. Sharma PGIMS |
| Address |
Department of anaesthesiology and critical care
Pt B.D. Sharma PGIMS
Rohtak
Rohtak HARYANA 124001 India |
| Phone |
8220832202 |
| Fax |
|
| Email |
karthik.ders@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
M karthik |
| Designation |
Postgraduate student |
| Affiliation |
Pt B.D. Sharma PGIMS |
| Address |
Department of anaesthesiology and critical care
Pt B.D. Sharma PGIMS
Rohtak
Rohtak HARYANA 124001 India |
| Phone |
8220832202 |
| Fax |
|
| Email |
karthik.ders@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology and critical care |
| Address |
2nd floor , Modular building complex
Pt B.D. Sharma PGIMS
Rohtak |
| 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 |
| karthik |
Pt B.D. Sharma PGIMS |
Department of anaesthesiology and critical care,
2nd floor Modular building complex,
Pt B.D. Sharma pgims,
Rohtak Rohtak HARYANA |
8220832202
karthik.ders@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee |
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 |
i-gel |
Comparison of fibre optic guided tracheal intubation through LMA protector versus i-gel in adult paralysed patients
Total duration of intervention:3 to 5 minutes |
| Comparator Agent |
Laryngeal mask airway protector |
Comparison of fibreoptic guided tracheal intubation through LMA protector versus i-gel in adult paralysed patients
Total duration of intervention:3 to 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex from age 18 to 70 years belonging to American society of anaesthesiologists (ASA) physical status1 or 2 scheduled for elective surgery under general anaesthesia will be included. |
|
| ExclusionCriteria |
| Details |
Patients with
Anticipated difficult airway
BMI >35kg/sq.meter
Inter incisor distance of <3.2 cm
Pregnancy
Known gastro esophageal reflex
Upper airway pathology
Surgical procedures involving oral cavity or in prone position
Recent upper respiratory tract infection
Patients refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fibreoptic guided total tracheal intubation time |
At 0 minute, before start of surgery at the time of anaesthesia induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean time of insertion
Ease of insertion
Oropharyngeal leak pressure
Fibreoptic view of placement
Adverse effects |
Baseline
baseline
Baseline
10 minutes
At 1 hour and 24 hours after surgery
|
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2023 |
| Date of Study Completion (India) |
15/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/11/2023 |
|
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Providing a safe airway is the prime responsibility of an anaesthesiologist. Supra glottic airway devices (SAD) are being widely used for airway management in the anaesthetic field, critical care and emergency situations. Since the introduction of the first generation classic laryngeal mask airway (cLMA), the evolution in supraglottic airway designs has been a continuous process. Second generation SADs incorporate a second drainage tube to enhance the safety of supraglottic airway devices. In current scenario they are not only used as a ventilating device but also act as conduit for planned blind as well as fiberoptic guided intubation in anticipated or unanticipated difficult laryngoscopies.i-gel (Intersurgical, Berkshire, UK) is a promising second-generation SAD which has gained popularity over last decade because of its anatomical shape and gel filled cuff. The airway channel of i-gel is shorter and wider compared to that of the other SADs, allowing the adult size endotracheal tube to easily pass through it. Its large bowl, better alignment with glottis along with the absence of aperture bars makes i-gel a favorable conduit for fibreoptic-guided tracheal intubation. The LMA Protector (Teleflex Medical Europe Ltd., Athlone, Ireland) is a recently introduced, second-generation SAD with design features that minimizes the risk of gastric aspiration. In comparison to the i-gel, there are two gastric drainage tubes on either side of the ventilation channel and an enlarged air inflatable cuff.In addition,the airway lumen of the LMA Protector is wide enough to pass an adequately sized tracheal tube. Hence, LMA Protector can be used as a conduit for fibreoptic-guided tracheal intubation.As there is no previous randomized trial primarily comparing fibreoptic-guided tracheal intubation via the LMA Protector with i-gel using polyvinyl chloride ( PVC ) endotracheal tube. So, we planned the current study to compare fibreoptic-guided tracheal intubation through the i-gel with the LMA Protector using PVC ETT. |