| CTRI Number |
CTRI/2025/08/092207 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of clinical method and ultrasound to confirm correct placement of breathing device(Laryngeal Mask Airway Blockbuster) during Anaesthesia |
|
Scientific Title of Study
|
To compare clinical versus ultrasound assessment for correct placement of Laryngeal Mask Airway Blockbuster: A randomized prospective 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 Shivi Mishra |
| Designation |
PG junior resident 1 |
| Affiliation |
Government Institute Of Medical Sciences |
| Address |
S2-1608,Supertech Czar, Omicron-1, Greater Noida near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
8795280836 |
| Fax |
|
| Email |
mishrashivi.sm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nazia Nazir |
| Designation |
Professor |
| Affiliation |
Government Institute Of Medical Sciences |
| Address |
Department of Anaesthesia, 1st floor, OT Complex, GIMS, Greater Noida near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9560102957 |
| Fax |
|
| Email |
nazunazir@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivi Mishra |
| Designation |
PG junior resident 1 |
| Affiliation |
Government Institute Of Medical Sciences |
| Address |
S2-1608,Supertech Czar, Omicron-1, Greater Noida near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
8795280836 |
| Fax |
|
| Email |
mishrashivi.sm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences, Kasna, Greater Noida, GBN, Uttar Pradesh, India, 201310 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences |
| Address |
Government Institute of Medical Sciences, Kasna, Greater Noida, GBN, Uttar Pradesh, India, 201310 |
| 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 Shivi Mishra |
Government Institute of Medical Sciences |
Department of Anaesthesia, 1st floor, OT Complex, GIMS, Kasna, Greater Noida. Gautam Buddha Nagar UTTAR PRADESH |
8795280836
mishrashivi.sm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K805||Calculus of bile duct without cholangitis or cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of American Society of Anaesthesiologists (ASA) physical status I&II, Age 18.5-60 years, BMI 18-30 kg/m2 Undergoing elective surgery under general anaesthesia in the supine position.
|
|
| ExclusionCriteria |
| Details |
Patients with
History of difficult airway,
history of airway stenosis, airway mass,
hyperthyroidism, goitre,
carotid stenosis,
gastroesophageal reflux, aspiration, and
• history of neck surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare clinical versus ultrasound assessment for correct placement of Laryngeal Mask Airway (LMA) Blockbuster in adult patients undergoing elective surgery under general anaesthesia. |
5 mins, 10 mins, 20 mins, 30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To measure and compare the average peak inspiratory pressure during inspiration in both the groups.
2.To measure total time taken for assessment of correct placement of LMA Blockbuster by each method.
|
5 mins, 10 mins, 20 mins, 30 mins. |
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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 Yet Recruiting |
| 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
|
The development of
supraglottic airway devices (SADs) has revolutionized airway management during
general anesthesia. The use of SADs is now standard in airway management
technique, and they fill the niche between the face mask and tracheal tube in
terms of both airway anatomy and degree of invasion. Anesthesiologists
need an effective and reliable method to confirm LMA placement definitively
without interrupting ventilation.
Ultrasound
is noninvasive, and can be a reliable means of assessing the correct placement
of SADs [1-3]. The laryngeal mask airway (LMA) is widely used as they are
easier to insert than an endotracheal tube, but there is a greater likelihood
of misplacement. Anaesthesiologists may not always be able to confirm the exact
position of an LMA promptly, potentially resulting in inadequate ventilation, and
in turn resulting in need for reinsertion. To avoid these complications, it is
essential to be able to determine the reason for inadequate ventilation
quickly. Current methods to assess LMA placement include the following:
auscultation, the leakage test, insertion of a suction tube into the drainage
conduit, the bubble test, and fiberoptic examination [2, 3, 7]. While these
techniques are simple and widely used, in recent years, point-of-care
ultrasound (POCUS) has emerged as a promising non-invasive tool for real-time
airway assessment. |