| CTRI Number |
CTRI/2025/07/091862 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of three different techniques of insertion of specialized airway device called PLMA.
In patient undergoing general anesthesia. |
|
Scientific Title of Study
|
Comparision of Flexi-slip stylet, Introducer tool and Standard digital technique of Proseal Laryngeal Mask Airway(PLMA) insertion-A randomized control 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 |
DR SHILPA H M |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KMC-RI hubli |
| Address |
Karnataka medical college and research institute.
Department of Anaesthesiology ,room no 206, IP division
Vidyanagar
Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
8884088476 |
| Fax |
|
| Email |
shillupatil1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MILON V MITRAGOTRI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KMC-RI hubli |
| Address |
Karnataka medical college and research institute.
Department of Anaesthesiology ,room no 206, IP division
Vidyanagar
Hubli.
Dharwad
KARNATAKA
580021
India |
| Phone |
7406796763 |
| Fax |
|
| Email |
milon.mitragotri4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHILPA H M |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KMC-RI hubli |
| Address |
Karnataka medical college and research institute.
Department of Anaesthesiology ,room no 206, IP division
Vidyanagar
Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
8884088476 |
| Fax |
|
| Email |
shillupatil1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka medical college and research institute.
Department of Anaesthesiology ,room no 206, IP division
Vidyanagar
Hubballi
pin code 580021
Dharwad district
Karnataka state
India
|
|
|
Primary Sponsor
|
| Name |
Karnataka medical college and research instituteVidyanagarHubli |
| Address |
Karnataka medical college and research institute.
Department of Anaesthesiology ,room no 206, IP division
Vidyanagar
Hubli |
| 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 Shilpa H M |
Karnataka medical College and research institute |
Karnataka medical college and research institute.
Department of Anaesthesiology ,room no 206, IP division
Vidyanagar
Hublli
Dharwad
KARNATAKA |
8884088476
shillupatil1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flexi slip Stylet tool technique |
The patients will be preoxygenated with 100% oxygen for three minutes before induction of anaesthesia. Pre medication will be administered with Injection(Inj) glycopyrrolate 0.004mg/kg intravenous(iv), Injection midazolam 0.05mg/kg iv and Inj fentanyl 2mcg/k iv. Patients will be induced with Inj propofol 2mg/kg iv until adequate depth of anaesthesia is obtained(loss of response to verbal commands , jaw relaxation and no movement with adequate face mask ventilation) and Inj succinylcholine 1mg/kg iv will be administered.
Appropriate size PLMA will be selected according to the patient’s weight (size 3 for those/=50 kg, size 4 for those 50 kg). The cuff will be fully deflated and back surface will be lubricated with water soluble KY jelly. Patients head will be placed in sniffing position and a well-trained anaesthesiologist(already performed 30 PLMA insertions before) will insert the PLMA according to the group allocation as follows:
In group A (n=40) : A flexi slip stylet tool will be lightly lubricated and passed down the drainage tube until the tip of the stylet is completely emerging from its distal end. Following this, the lubricated PLMA will be inserted and cuff will be inflated to a pressure as suggested by manufacturer.
|
| Comparator Agent |
Introducer tool technique |
The patients will be preoxygenated with 100% oxygen for three minutes before induction of anaesthesia. Pre medication will be administered with Injection(Inj) glycopyrrolate 0.004mg/kg intravenous(iv), Injection midazolam 0.05mg/kg iv and Inj fentanyl 2mcg/k iv. Patients will be induced with Inj propofol 2mg/kg iv until adequate depth of anaesthesia is obtained(loss of response to verbal commands , jaw relaxation and no movement with adequate face mask ventilation) and Inj succinylcholine 1mg/kg iv will be administered.
Appropriate size PLMA will be selected according to the patient’s weight (size 3 for those/=50 kg, size 4 for those 50 kg). The cuff will be fully deflated and back surface will be lubricated with water soluble KY jelly. Patients head will be placed in sniffing position and a well-trained anaesthesiologist(already performed 30 PLMA insertions before) will insert the PLMA according to the group allocation as follows:
In group B (n=40) : The standard digital technique will be used in which the lubricated PLMA will be inserted using the index finger of the dominant hand while holding the PLMA with non-dominant hand and advancing it around the palatopharyngeal curve. Cuff will then be inflated to a pressure as suggested by manufacturer
|
| Comparator Agent |
standard digital technique |
The patients will be preoxygenated with 100% oxygen for three minutes before induction of anaesthesia. Pre medication will be administered with Injection(Inj) glycopyrrolate 0.004mg/kg intravenous(iv), Injection midazolam 0.05mg/kg iv and Inj fentanyl 2mcg/k iv. Patients will be induced with Inj propofol 2mg/kg iv until adequate depth of anaesthesia is obtained(loss of response to verbal commands , jaw relaxation and no movement with adequate face mask ventilation) and Inj succinylcholine 1mg/kg iv will be administered.
Appropriate size PLMA will be selected according to the patient’s weight (size 3 for those/=50 kg, size 4 for those 50 kg). The cuff will be fully deflated and back surface will be lubricated with water soluble KY jelly. Patients head will be placed in sniffing position and a well-trained anaesthesiologist(already performed 30 PLMA insertions before) will insert the PLMA according to the group allocation as follows:
In group C (n=40): The PLMA will be inserted using the metal introducer according to the manufacturer’s instructions, The patient mouth was opened and the lubricated PLMA will be inserted using the introducer and cuff will be inflated to a pressure as suggested by manufacturer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A) Patients undergoing elective surgeries under general anaesthesia for moderate duration (up to two hours) in supine position.
B) Adult patients between 18-60 years of age.
C)American society of Anaesthesiologist’s (ASA) -classification I-II.
D)Patients giving informed written and valid consent.
|
|
| ExclusionCriteria |
| Details |
Patient requiring mechanical ventilation following surgery
Inadequate nil by mouth status
Pregnant women
Limited mouth opening
Patient who had upper respiratory tract infection with in past week.
Obese patient with body mass index more than 30kg/m2
Patient of upper airway pathology
Chronic obstructive pulmonary disease, bronchial asthma, active airway
disease.
Patient having history of oesophageal or gastric surgeries.
Head and neck surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the first attempt insertion success rate |
baseline time T0-at the time of insertion
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A) To determine ease of insertion |
i. Grade 1:Smooth(no resistance)
ii. Grade 2:Mild resistance requiring additional manoeuvres
iii. Grade 3:high resistance requiring re-insertion
iv. Grade 4:Failed insertion
|
A) To estimate time taken for insertion using each of the techniques.
|
nil |
| To evaluate hemodynamic stability during insertion |
• P1-baseline measurement,
• P2-immediately after insertion,
• P3-one minutes after insertion,
• P4- five minutes after insertion,
• P5-ten minutes after insertion
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
07/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, randomized clinical study involving 120 adult patients undergoing elective surgery under general anaesthesia. After obtaining ethical clearance, CTRI registration, and informed written consent, patients will be randomly divided into three groups (n=40 each) to compare different techniques of ProSeal Laryngeal Mask Airway (PLMA) insertion: -
Group A: Insertion using a flexi-slip stylet. -
Group B: Standard digital insertion technique. -
Group C: Insertion using a metal introducer. All patients will receive standard preoperative assessment and monitoring. Anaesthesia will be induced with glycopyrrolate, midazolam, fentanyl, propofol, and succinylcholine. Appropriate PLMA size will be selected based on weight. A maximum of three insertion attempts will be allowed before declaring failure. Primary parameters assessed include insertion time, ease of insertion, number of attempts, and haemodynamic changes at various time points (baseline, immediately after insertion, and at 1, 5, and 10 minutes post-insertion). Complications such as blood on PLMA, aspiration, nausea, vomiting, and sore throat will be recorded. The study aims to evaluate and compare the success rate, ease, and safety of three different PLMA insertion techniques. |