CTRI

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CTRI Number

CTRI/2025/02/081397 [Registered on: 27/02/2025] Trial Registered Prospectively

Last Modified On:

17/03/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Diagnostic accuracy study

Study Design

Other

Public Title of Study

Comparing the role of lung ultrasonography with that of existing standard protocol in detecting the pulmonary complications after abdominal cancer surgeries

Scientific Title of Study

Role of Lung Ultrasonography as a routine screening tool for early detection of Post Operative Pulmonary complications in patients undergoing abdominal oncological surgeries: A comparison with the standard existing protocol

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	GAYATRI SAGDEO
Designation	SENIOR RESIDENT
Affiliation	DR BRA IRCH, AIIMS NEW DELHI
Address	DEPARTMENT OF ONCOANAESTHESIA AND PALLIATIVE MEDICINE, DR BRA IRCH, AIIMS NEW DELHI New Delhi DELHI 110029 India
Phone	6238843886
Fax
Email	sagdeogayatri8@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Dr Seema Mishra
Designation	Professor
Affiliation	DR BRA IRCH, AIIMS, New Delhi
Address	Department of Oncoanaesthesia and Palliative Medicine, DRA IRCH, AIIMS Delhi Department of Oncoanaesthesia and Palliative Medicine, DRA IRCH, AIIMS Delhi New Delhi DELHI 110029 India
Phone	9899061105
Fax
Email	SeemaMishra2003@gmail.com

Details of Contact Person
Public Query

Name	Gayatri Sagdeo
Designation	Senior Resident
Affiliation	DR BRA IRCH, AIIMS, New Delhi
Address	Department of Oncoanaesthesia and Palliative Medicine, DRA IRCH, AIIMS Delhi Department of Oncoanaesthesia and Palliative Medicine, DRA IRCH, AIIMS Delhi New Delhi DELHI 110029 India
Phone	6238843886
Fax
Email	sagdeogayatri8@gmail.com

Source of Monetary or Material Support

Department of Oncoanaesthesia and Palliative medicine, DR BRA IRCH, AIIMS New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, Delhi- 110029

Primary Sponsor

Name	AIIMS New Delhi
Address	Department of Oncoanaesthesia and Palliative medicine, DR BRA IRCH, AIIMS New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, Delhi 110029
Type of Sponsor	Other [Autonomous Under Ministry of Health and Family Welfare]

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 Gayatri Sagdeo	DR BRA IRCH	Department of Oncoanaesthesia & Palliative medicine,ICU and surgical oncology ward, 5th and 6th floor New Delhi DELHI	6238843886 sagdeogayatri8@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
ETHICS COMMITTEE, AIIMS, NEW DELHI	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C15-C26\|\|Malignant neoplasms of digestive organs,

Intervention / Comparator Agent

Type	Name	Details
Intervention	nil	nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Patients undergoing elective abdominal cancer surgeries with a duration exceeding 2 hours.

ExclusionCriteria

Details

1. Patient refusal.
2. Detection of inoperable masses during surgery.
3. Emergency surgeries.
4. Re-exploration surgeries within the same admission.
5. Patients requiring re-exploration within one month of an external previous surgery.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Detection rates of postoperative pulmonary complications identified by lung ultrasonography and chest xray	postoperative day 0,1,2

Secondary Outcome

Outcome	TimePoints
To compare the timing of radiological manifestations of PPCs on LUS and chest X-ray with the onset of clinically relevant pulmonary symptoms.	postoperative day 0,1,2
To evaluate and compare the time required to conduct a lung ultrasound of both hemithoraces versus the time to complete a bedside chest X-ray, defined as the interval from ordering the X-ray to obtaining a digital image	postoperative day 0,1,2
To determine if Lung Ultrasound Score on Postoperative Day 0 Is Predictive of the Occurrence of pulmonary Complications up to postoperative day 3 after abdominal cancer Surgery	postoperative day 0,1,2,3

Target Sample Size

Total Sample Size="110"
Sample Size from India="110"
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)

10/03/2025

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)
Modification(s)

Not Yet Recruiting

Recruitment Status of Trial (India)

Open to Recruitment

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 study aims to rigorously evaluate lung ultrasonography(LUS) as a routine screening tool for postoperative pulmonary complications(PPC) detection, comparing its efficacy and efficiency to the current standard protocol of bedside CXR. Furthermore, we seek to examine the temporal correlation between radiological manifestations and clinical symptoms of PPCs, thus assessing the potential for LUS to pre-emptively identify complications before overt clinical signs. Additionally, we aim to investigate the operational feasibility of integrating LUS into routine postoperative care, comparing the time investment for LUS and CXR within standard clinical workflows.