| CTRI Number |
CTRI/2025/09/094616 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare lung ultrasound in detecting lung collapse (atelectasis) after general anaesthesia when using a breathing tube (endotracheal tube) versus a mask device (Proseal laryngeal mask airway)" |
|
Scientific Title of Study
|
Lung ultrasound guided evaluation of atelectasis after general anaesthesia using proseal laryngeal mask airway and endotracheal tube:a randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arohi Maheshwari |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 415, BL taneja block, 4th floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8290107955 |
| Fax |
|
| Email |
arohi.m.2510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arohi Maheshwari |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 303, BL taneja block, 4th floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8290107955 |
| Fax |
|
| Email |
arohi.m.2510@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arohi Maheshwari |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 415, BL taneja block, 4th floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8290107955 |
| Fax |
|
| Email |
arohi.m.2510@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated hospitals |
| Address |
JLn Marg new delhi 110002 |
| 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 Arohi Maheshwari |
Lok Nayak hospital |
Room no. 415, unit 3, department of anesthesiology , BL taneja block 4th floor
Central
DELHI |
08290107955
arohi.m.2510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Maulana Azad Medical College and associated hospitals, New Delhi |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Proseal laryngeal mask airway as an airway device in general anaesthesia | (Procedure Reference: Degree of atelectasis assessed by lung ultrasound scoring , Procedure details: Lung ultrasound assessment - 5 minutes
To be done four times in perioperative period )
| | 2 | Comparator Arm (Non Ayurveda) | | - | Endotracheal tube as an airway device in general anaesthesia | Lung atelectasis to be assessed by lung ultrasound scoring system |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 -65 years with Physical status ASA I-III and BMI 19-30 kg/m² and Anticipated duration of surgery 30 minutes to 2 hours. |
|
| ExclusionCriteria |
| Details |
Difficulty in performing lung ultrasound - chest fractures, deformities or surgery, respiratory disease- chronic obstructive pulmonary disease, respiratory infections, smoking, h/o general anaesthesia or mechanical ventilation within the month preceding surgery, congestive heart failure, chronic renal insufficiency, liver cirrhosis, pregnancy, anticipated difficult airway and patients at risk of aspiration
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean lung ultrasound scores |
30 min after removal of the airway device
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean lung ultrasound score |
15 min after securing the airway device and before device removal at the end of the surgery.
|
| SF ratio (SpO2/FiO2) ratio |
15 min after securing the airway device, before device removal at the end of the surgery and 30 min after device removal.
|
Lung dynamic compliance
|
15 min after securing the airway device and before device removal at the end of the surgery. |
| Incidence of postoperative pulmonary complications |
within 24 and 48 h post- surgery. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
20/09/2025 |
| 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="0"
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
|
This randomized controlled study compares the incidence of atelectasis after general anaesthesia in adult patients managed with a proseal laryngeal mask airway (PLMA) versus an endotracheal tube (ETT) . Using lung ultrasound as a bedside tool, the study evaluates lung ultrasound scores, oxygenation indices, lung compliance, and postoperative pulmonary complications. The aim is to determine whether PLMA use reduces atelectasis compared to ETT in infraumbilical and orthopaedic surgeries. |