| CTRI Number |
CTRI/2026/01/100103 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study to find out lung changes by scan in participants undergoing upper abdominal surgeries |
|
Scientific Title of Study
|
Lung Ultrasound to detect
Atelectasis after upper abdominal surgeries- an observational 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 |
Riyanka Benny |
| Designation |
First year postgraduate student |
| Affiliation |
|
| Address |
Department of Anesthesiology,
Second floor OT complex ,
St Johns Medical college and hospital,
Bengaluru-560034
Bangalore
Karnataka
560034
India
Bangalore KARNATAKA 560034 India |
| Phone |
9446172000 |
| Fax |
|
| Email |
riyankabenny05@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Karthik Jain |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anesthesiology,
Second floor OT complex ,
St Johns Medical college and hospital,
Bengaluru-560034
Bangalore
Karnataka
560034
India
Bangalore KARNATAKA 560034 India |
| Phone |
9845513713 |
| Fax |
|
| Email |
karthikjain@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Karthik Jain |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Anesthesiology,
Second floor OT complex ,
St Johns Medical college and hospital,
Bengaluru-560034
Bangalore
Karnataka
560034
India
Bangalore KARNATAKA 560034 India |
| Phone |
9845513713 |
| Fax |
|
| Email |
karthikjain@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, 2nd floor ot complex,
St Johns Medical college and hospital,
Bengaluru-560034,
Bangalore
Karnataka
560034
India |
|
|
Primary Sponsor
|
| Name |
Riyanka Benny |
| Address |
Department of Anaesthesiology, 2nd floor ot complex,
St Johns Medical college and hospital,
Bengaluru-560034,
Bangalore
Karnataka
560034
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Riyanka Benny |
St Johns Medical college and hospital |
Department of Anaesthesiology 2nd floor ot complex
ot complex room
Bengaluru-560034
Bangalore
Karnataka
560034
India Bangalore KARNATAKA |
9446172000
riyankabenny05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St John’s Medical college, Bengaluru |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 .Age: Adult patients aged between 18-75 years
2.Type of Surgery: Patients undergoing elective open upper abdominal surgeries of atleast 3 hours
duration (e.g.,Gastrectomy, Hepatectomy, Splenectomy, Pancreaticoduodenectomy).
3.Preoperative Status: Patients with an ASA (American Society of Anesthesiologists) physical
status classification of I—Ill. |
|
| ExclusionCriteria |
| Details |
l. Preexisting Lung Conditions: Patients with preexisting pulmonary diseases (e.g., chronic
obstructive pulmonary disease [COPD, Interstitial lung disease]
2. Hemodynamic Instability: Patients with intraoperative hemodynamic instability requiring
immediate postoperative ventilation or advanced circulatory support.
3. Pregnant patients.
4.Technical Limitations: Poor acoustic window or technical limitations preventing adequate lung
ultrasonography assessment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the incidence of postoperative atelectasis in open upper abdominal surgeries of atleast
3 hours duration using lung ultrasonography. |
At baseline, day 1 and day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse the factors associated with postoperative Atelectasis.
|
within 5 days post surgery |
To correlate whether early postoperative atelectasis was associated with postoperative
pneumonia, ICU stay and Length of hospital stay |
within 5days post surgery. |
|
|
Target Sample Size
|
Total Sample Size="79" Sample Size from India="79"
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)
|
11/01/2026 |
| 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="2" Months="0" 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
|
Postoperative pulmonary complications (PPCs) are adverse outcomes following major elective upper abdominal surgeries, with atelectasis being one of the most common [l .PPC are major source of morbidity and mortality for patients undergoing abdominal surgeries [5]. Atelectasis, characterized by the partial or complete collapse of lung tissue,[4] can contribute to hypoxemia, prolonged hospital stays, and increased morbidity. Atelectasis is defined as lung opacification with a shift of the mediastinum, hilum, or hemidiaphragm towards affected area and compensatory overinflation in the adjacent non atelectactic lung on chest X-rays[2] .Atelectasis has been reported to contribute to postoperative pulmonary complications through ventilation perfusion mismatch, reduced alveolar clearance, or structural dysfunction [3]. Traditional methods for diagnosing atelectasis, such as chest X-rays and computed tomography scans, may have limitations in sensitivity, accessibility, and radiation exposure and atelectasis is not evident on conventional chest X-rays until it’s significant [1,4] . Lung ultrasonography (LUS) has emerged as a reliable, non-invasive, bedside tool for detecting atelectasis, offering real-time imaging with high diagnostic accuracy, successfully predicting the severity of pulmonary complications compared to computed tomography [5]. This study aims to estimate the incidence of postoperative atelectasis in patients undergoing major elective upper abdominal surgeries using lung ultrasonography. By identiWing the frequency and severity of atelectasis, this research may help improve early detection, guide preventive strategies, and optimize perioperative respiratory care, ultimately enhancing patient outcomes.
After obtaining IEC approval, patients who meet the inclusion criteria and consenting for the study will be enrolled. Preoperative assessment of patients like demographics-name,age,sex, ASA score,height, weight,BMI will be noted. Any comorbidities like diabetes, hypertension ,asthma, history of smoking and other habits will be noted . Surgical diagnosis and procedure planned will be noted. Preoperatively, before induction of anesthesia ultrasound of lungs will be done and ultrasound scores of upper anterior, lower anterior, and PLAPs points will be noted with the patient in supine position. Ultrasound of lungs will be done with new ultrasound machine Versana active and curvilinear probe will be used. PLAPS point is Posterolateral Alveolar And/or Pleural Syndrome Point located in posterolateral chest wall between the posterior axillary line and the paravertebral region often at the level of diaphragm. To find the upper and lower points, place 4 fingers (except the thumb) of the left hand below the clavicle , on the right side of the patient with the fingertips on the sternum. The upper point is at the base of the second and third fingers. The lower point is in the centre of the palm when the right hand is placed below the left with the forefingers touching. Then we will switch sides and repeat the same. To scan base of the lungs at the thoracoabdominal border, move from lower blue point around the chest wall to the posterior axillary line. B lines will be observed. B lines, also called comet tails are vertical artefacts that appear as echogenic lines and extend from the pleural line into the lung parenchyma. They are created by discreet short path reverberation artifacts due to interstitial edema,increased fluid, or fibrosis in the interlobular septae seen in conditions like pulmonary edema, interstitial lung diseases and pneumonia. Score 0 is given for normal aeration with LUS showing 0-2 B lines. Score I is given for small loss of aeration, with LUS showing greater than or equal to 3 B lines. Score 2 is given for moderate loss of aeration with multiple coalescent B lines on LUS. Score 4 is given for severe loss of aeration with tissue sign positive ( atelectasis) on LUS. The maximum score is 3 for each lung area and total scoring is out of 18. Inside the operation theatre, standard monitors will be attached. General anaesthesia, induction and maintenance of anaesthesia will be done as per standard protocols. Ventilatory parameters are standardized according to : Mode : Volume Controlled Tidal Volume: 6-8 ml/kg Respiratory Rate: 12-14 Inspiratory : Expiratory ratio : 1:2 Positive End Expiratory Pressure (PEEP) : 5-6 cm H20 Choice of analgesia will be chosen as per discretion of concerned anesthesiologists. After extubation patient will be shifted to postoperative recovery area and then Lung ultrasound will be repeated in recovery room after 30 minutes after extubation as per protocols. LUS scores will be evaluated. Subsequently patient will be followed up for 5 days. Vitals, patient level of consciousness, body temperatures will be noted along with need for any ventilatory support/reintubation, oxygen support, ICU admission, mode of analgesia ,method of physiotherapy and need of any bronchodilators. Chest Xray will be noted on postoperative days land 3. Postoperative pulmonary complications will be assessed like pneumonia, pneumothorax etc.Pneumonia is defined as two or more serial chest Xrays showing new infiltrates and atleast two of the following clinical findings: l.Fever, 2. New onset worsening cough or dyspnea, 3.new onset purulent sputum or increased secretions or 4. Bronchial breathing or rales,5. Decrease in Sp02, 6. Leucopenia/ leucocytosis. Total length of hospital stay of the patient will be noted. Incidence of Atelectasis will be calculated based on lung USG. Preoperative and intraoperative factors will be correlated with incidence of atelectasis. Atelectasis will be correlated with incidence of pneumonia , ICU stay and length of hospital stay. |