| CTRI Number |
CTRI/2026/04/107968 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of ultrasound to predict lung complications after major cancer surgery |
|
Scientific Title of Study
|
An Observational study on Efficacy of Lung and Diaphragm Ultrasonography in Prediction of Postoperative Pulmonary Complications in Major Oncological 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 |
Iftesham Shekh |
| Designation |
Postgraduate Resident |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anaesthesia Himalayan Institute of Medical Sciences
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9690274669 |
| Fax |
|
| Email |
rubishekh5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Ramakrishnan |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anaesthesia Himalayan Institute of Medical Sciences
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9149225153 |
| Fax |
|
| Email |
priyakrishnan@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Ramakrishnan |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anaesthesia Himalayan Institute of Medical Sciences
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9149225153 |
| Fax |
|
| Email |
priyakrishnan@srhu.edu.in |
|
|
Source of Monetary or Material Support
|
| Himalayan Institute of Medical Sciences
Jollygrant
Dehradun
Uttarakhand
248140
India |
|
|
Primary Sponsor
|
| Name |
Swami Rama Himalayan university |
| Address |
Himalayan Institute of Medical Sciences SRHU campus Jollygrant dehradun Uttarakhand 248140 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Gurjeet Khurrana |
Department of Anaesthesiology
Himalayan Institute of Medical Science |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priya Ramakrishnan |
Himalayan Institute of Medical Sciences |
Department of Anaesthesia
Recovery Room 2nd floor
Cancer Care Research Centre
Himalayan Hospital
SRHU Campus
Dehradun
Uttaranchal
Dehradun
UTTARANCHAL |
9149225153
priyakrishnan@srhu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee Swami Rama Himalayan University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D099||Carcinoma in situ, unspecified, (2) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, (3) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (4) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (5) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (6) ICD-10 Condition: C20||Malignant neoplasm of rectum, (7) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (8) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (9) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, (10) ICD-10 Condition: C749||Malignant neoplasm of unspecifiedpart of adrenal gland, (11) ICD-10 Condition: C659||Malignant neoplasm of unspecifiedrenal pelvis, (12) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
elective major oncological surgeries
American society of anaesthesiology physical status grade I,II,III
patient providing written informed consent |
|
| ExclusionCriteria |
| Details |
patient refusal to participate
emergency surgery
intubation with laryngeal mask airway
pregnant and lactation women
postoperative mechanical ventilation
pre existing severe pulmonary disease
neuromuscular disorder
morbid obesity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| lung and diaphragm ultrasound |
lung ultrasound preoperatively and on post operatively day 0 1 2
diaphragm ultrasound preoperatively and on post operatively day 0 1 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Spo2, O2, temperature, respiratory rate, Numeric rating score, TLC, post operative analgesia, Incentive spirometry(balls lift) |
Spo2 at 6 12 18 24 30 36 42 48 54 60 66 72 hour after extubation
O2 at 6 12 18 24 30 36 42 48 54 60 66 72 hour after extubation
Temprtaure at 6 12 18 24 30 36 42 48 54 60 66 72 hour after extubation
Respiratory rate at 6 12 18 24 30 36 42 48 54 60 66 72 hour after extubation
NRS preoperatively and on post operative day 0 1 2
TLC preoperatively and on post operative day 0 1 2
Incentive spirometry at 6 12 18 24 30 36 42 48 54 60 66 72 hour after extubation
Post operative analgesia in form of epidural at 24 48 72 hour or patch at 28 48 72 hour or IV at 24 48 72 hour or PCA pump on 24 48 72 hour |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/04/2026 |
| 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="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
|
Postoperative pulmonary complications (PPCs) are common and serious adverse outcomes following major surgeries, with an incidence ranging from 5% to 30%, and even higher in high-risk populations such as oncologic patients. These complications—including atelectasis, pneumonia, and respiratory failure—lead to increased morbidity, prolonged hospitalization, ICU admissions, and higher mortality. Patients undergoing major oncologic surgeries are particularly vulnerable due to extensive procedures, compromised respiratory mechanics, and preexisting risk factors such as malnutrition, prior chemotherapy/radiotherapy, and comorbidities. Traditional risk assessment tools provide only static preoperative estimates and may not capture dynamic postoperative changes. Lung ultrasound (LUS) is a non-invasive bedside tool that detects pulmonary abnormalities with high sensitivity, while diaphragm ultrasound (DUS) evaluates diaphragmatic function, an important determinant of respiratory mechanics. This study aims to evaluate whether the combined application of lung and diaphragm ultrasound improves early prediction of postoperative pulmonary complications in adult patients undergoing major oncologic surgeries.
|