| CTRI Number |
CTRI/2024/09/074355 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the occurrence of water logging in patients lungs by scanning the lungs by ultrasonogram during the operation in the womb through the birth canal |
|
Scientific Title of Study
|
The incidence of Pulmonary Alveolar Interstitial Syndrome (PAIS) by Lung Ultrasonography (LUS) during operative hysteroscopy - A Prospective Observational Pilot 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 |
Dr Harish Balakrishnan |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9865203302 |
| Fax |
|
| Email |
harish7134@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthirajan P |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903468132 |
| Fax |
|
| Email |
sakthiab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Balakrishnan |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9865203302 |
| Fax |
|
| Email |
harish7134@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry - 605006. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry - 605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Harish Balakrishnan |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
Department of Anaesthesiology and Critical Care, 2nd floor, Institute block, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry - 605006.
Pondicherry
PONDICHERRY |
9865203302
harish7134@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Institute of Postgraduate Medical Education and Research, Institutional Ethics Committee for Observational Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J810||Acute pulmonary edema, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Adult female patients undergoing elective operative hysteroscopic procedures with intrauterine fluid irrigation under neuraxial or general anesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients pre-diagnosed with lung disorders
2. Patients with chest deformities/with narrow rib spaces
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the proportion of patients developing Pulmonary Alveolar Interstitial Syndrome (PAIS) by LUS in women undergoing Operative Hysteroscopy with Intrauterine Fluid Irrigation. |
Intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the proportion of patients requiring intraoperative and postoperative oxygen therapy with or without positive pressure (non-invasive or invasive ventilation) with FiO2 more than 0.4 to maintain saturation more than 94 percent. |
Intraoperative and postoperative period |
| To determine the proportion of patients requiring diuretic therapy. |
Intraoperative and postoperative period |
| To compare signs of Pulmonary Alveolar Interstitial Syndrome by Lung ultrasonography with chest auscultation. |
Intraoperative period |
| To determine the proportion of patients in whom Lung Ultrasonography is feasible till the end of the surgery. |
Intraoperative period |
|
|
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)
|
10/11/2024 |
| 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 Applicable |
| 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 is a prospective, observational, non-randamized, single-centre trial which aims to investigate the incidence of Pulmonary Alveolar Interstitial Syndrome (PAIS) using Lung Ultrasonography (LUS) during operative hysteroscopy. After obtaining necessary consent, eligible patients will be enrolled. Anesthesiologists will decide the type of anesthesia, and patients will be monitored continuously during surgery. LUS will be performed at regular intervals to detect PAIS, with images analyzed for B-lines indicating pulmonary fluid. The primary outcome is the detection of proportion of patients developing PAIS during the procedure by LUS. Secondary outcomes include detection of patients requiring oxygen therapy/diuretic therapy, compare signs between LUS and chest auscultation. |