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CTRI Number  CTRI/2025/03/081571 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 02/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Single Arm Study 
Public Title of Study   Early detection of Post Operative Complications following upper abdominal surgeries with the use of USG  
Scientific Title of Study   Evaluation of Lung Ultrasound as a screening tool to detect Early Post Operative Complications following major upper open abdominal surgeries  
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 Mamta Harzai 
Designation  Professor 
Affiliation  DR RMLIMS LUCKNOW 
Address  DR RMLIMS 2ND Floor Academic Block Department of Anaesthesiology And CCM Vibhuti Khand,Gomtinagar LUCKNOW

Lucknow
UTTAR PRADESH
226010
India 
Phone  8176007015  
Fax    
Email  mamtaharjaidoctor@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamta Harzai 
Designation  Professor 
Affiliation  DR RMLIMS LUCKNOW 
Address  DR RMLIMS 2ND Academic Block Department of Anaesthesiology And CCM Vibhuti Khand,Gomtinagar LUCKNOW

Lucknow
UTTAR PRADESH
226010
India 
Phone  8176007015  
Fax    
Email  mamtaharjaidoctor@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Hemant Kumar 
Designation  Junior resident 
Affiliation  DR RMLIMS LUCKNOW 
Address  DR RMLIMS DR SC RAI Hostel Room NO.614 Department of Anaesthesiology And CCM Vibhuti Khand,Gomtinagar LUCKNOW
VIBHUTI KHAND,GOMTINAGAR LUCKNOW
Lucknow
UTTAR PRADESH
226010
India 
Phone  8299827498  
Fax    
Email  asha00157@gmail.com  
 
Source of Monetary or Material Support  
Self Funded DR RMLIMS Vibhuti khand Gomtinagar Lucknow UP 226010 
 
Primary Sponsor  
Name  Dr Hemant kumar 
Address  DR RMLIMS Vibhuti khand Gomtinagar LUCKNOW UP 226010 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Mamta Harjai  DR RAM MANOHAR LOHIA INSTITUTE  DR RMLIMS 2nd Floor Academic Block Department of Anaesthesiology And CCM VIBHUTI KHAND,GOMTINAGAR LUCKNOW
Lucknow
UTTAR PRADESH 
08176007015

mamtaharjaidoctor@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL EHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  USG LUNG  USG lung by portable sonosite till day 3 of pt 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient refusal to give consent
Patient ASA physical status 3, 4, and Emergency cases

Patients with any preoperative respiratory involvement either coexisting or diagnosed during the preoperative assessment (clinically/ radiologically or sonologicaly)
 
 
ExclusionCriteria 
Details  Patient refusal to give consent
Patient ASA physical status 3, 4, and Emergency cases
Patients with any preoperative respiratory involvement either coexisting or diagnosed during the preoperative assessment (clinically/ radiologically or sonologicaly)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of PPC’s with lung ultrasound and Chest X-ray in
early post operative period.
 
Baseline, post op.. Day 1,Day2,Day3
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Requirement of O2 supplementation
And Mode of O2 therapy
2. Requirement of Inotropic/vasopressors
Support
3. Total Duration of Hospital stay
 
baseline(day 0), post op day1,post op day2, post op day 3  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   02/05/2025 
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  
Post operative pulmonary complications (PPC) are respiratory
complications that occur within 48–72 hours following surgery. PPCs can
adversely influence recovery course of the patient in post operative period.
Incidence of PPCs is 5– 10% in patients undergoing non-thoracic surgery and
22% in high-risk patients (1).Even with minor surgeries, the incidence has been
reported up to 1–2%.
There is a wide spectrum of PPCs like pleural effusion, pneumothorax,
atelectasis, consolidation, pulmonary collapse, ARDS and interstitial syndrome
(2- 4) which can occur after non-thoracic or major abdominal surgeries, which
may affect clinical outcomes of the patient. The distinctive characteristic of
PPC’s is that they are preventable or modifiable to a certain extent even in
postoperative period. Many studies have been done to assess the preoperative
risk factors associated with PPC’s (5). Early detection of PPCs would enable
physicians to startintervention in time and, therefore prevent its negative impact
on patient outcome; hence, there is increasing interest in early detection of
pulmonarycomplications in post operative period to reduce patient’s morbidity
and mortality (1, 5).
Chest auscultations and chest radiograph are commonly used as diagnostic
modalities to detect PPCs in wards and ICU but have finite diagnostic accuracy
(6-9). Computed tomography (CT) is the gold standard for pulmonary pathology
but it is associated with significant ionizing radiation and the need for transfers
within the hospital, which has risks of its own (6). Interpretation with better
precision of chest infiltrates can be obtained by CT but due to its risk of
irradiation, less availability, cost factor and need of patient’s transportation to
radiology department; it is preferable only PPCs are strongly indicated.

1

Summary

Bedside Point of Care Lung Ultrasound (POCUS) is prompt, easy, non-
expensive and radiation free technique. It has been found that it has excellent

diagnostic accuracy for PPCs like pleural effusion, consolidation, pneumothorax,
atelectasis etc. in critically ill patients as compared to CT thorax. (6,7,9) CT
scanning requires transportation of a potentially critically ill patient which poses
huge risk to the patients. Also, CT scanning is associated with significant costs,
radiation and contrast burden. Lung ultrasonography is the answer to these
limitations.
Routine early lung ultrasound may detect PPCs early and with higher
accuracy to improve management in postoperative period, hence reducing patient
morbidity and over all adding to provision of better health care in major upper
gastrointestinal surgery especially open ones, which have higher chance of
PPC’s as compared to laparoscopic surgeries. (7, 10, 11)
Recent studies have revealed the role of ultrasound in detecting PPCs in
cardiac surgery and thoracic surgery and they have reported that ultrasound of the
lung can be helpful in detecting PPCs at early stage as compared to chest Xray
and can be used as a primary imaging technique to detect PPCs in post operative
period.
Patients undergoing major open abdominal surgeries have higher risk of
developing PPC’s due to many causes like surgical incision near diaphragm,
long duration of surgery, prolong immobility and inability to clear secretions.
This is the rationale behind our study to select this group i.e., patients
undergoing major abdominal surgery. Moreover, there are very few studies in
the literature which investigated the role of POCUS in detection of PPC’s (12)
Despite the less use of diagnostic X-rays in wards, the study has been designed
to compare the use of lung ultrasound and chest X-ray every 24 hrs for next 72
hrs. So the purpose of this prospective, observational study is to evaluate the
role of bedside ultrasound as a screening tool to assess patients’ lungs in post
operative period following major upper abdominal surgeries to detect PPCs at an
early stage and to compare it with chest x-ray.
 
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