| CTRI Number |
CTRI/2025/09/094424 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
How common are lung problems after abdominal operations? |
|
Scientific Title of Study
|
Postoperative Pulmonary Complications following abdominal surgeries: An observational study |
| Trial Acronym |
PPC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IECKMCMLR-01/2025/16 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avancha Chinmayee Sai Sathya |
| Designation |
Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesia and Operation Theatre Technology,
Kasturba Medical College,
Nandiguda Road,
Attavar,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9347807363 |
| Fax |
|
| Email |
avancha.mchpmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Kajal R Shetty |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesia and Operation Theatre Technology,
Kasturba Medical College,
Nandiguda Road,
Attavar, Mangalore
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8073814280 |
| Fax |
|
| Email |
kajal.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Avancha Chinmayee Sai Sathya |
| Designation |
Student |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesia and Operation Theatre Technology,
Kasturba Medical College,
Nandiguda Road,
Attavar,
Mangalore
KARNATAKA
575002
India |
| Phone |
9347807363 |
| Fax |
|
| Email |
avancha.mchpmlr2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore, MAHE |
|
|
Primary Sponsor
|
| Name |
Avancha Chinmayee Sai Sathya |
| Address |
Department of Anaesthesia and Operation Theatre Technology,
Kasturba Medical College,
Nandiguda Road,
Attavar,
Manglore,
Karnataka,
575002 |
| 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 |
| Avancha Chinmayee Sai Sathya |
Kasturba Medical College Hospital, Attavar and Dr. B. R. Ambedkar Circle, Mangalore |
Preoperative Setup, Operation Room, And Postoperative Setup
Dakshina Kannada
KARNATAKA |
9347807363
avancha.mchpmlr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing abdominal surgeries under general anaesthesia.
Both elective and emergency abdominal surgeries.
|
|
| ExclusionCriteria |
| Details |
Patients with pre-existing pulmonary conditions.
Pregnant patients and Obstetric cases.
Patient or family refusal.
Patients undergoing abdominal surgeries under regional anaesthesia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identifying the most frequently occurring PPC.
To identify risk factors that contribute to the development of PPCs. |
From induction of Anaesthesia upto 12 hours Post Surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of the standard medical treatment which is done using a Visual Analogue Scale.
To assess patient satisfaction and recovery. |
Before discharge from Post Operative Setup |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
08/09/2025 |
| 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="0"
Months="8"
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
|
Pulmonary complications postoperatively (PPC) are prevalent after abdominal surgery with general anaesthesia, and are known to incur drastic consequences, such as increased risk of respiratory failure, infection, and increased length of stay. A number of factors attribute to the risk of PPC, including obesity, COPD, anaesthesia, surgery and health state, and can cause symptoms such as increased breathlessness, cough, and oxygen saturation below 90%. The aim of this study is to identify the most common PPC and reducing these and providing better outcomes for patients |