| CTRI Number |
CTRI/2025/03/081831 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate unexpected events occurring in patients undergoing surgery on the chest |
|
Scientific Title of Study
|
Peri-operative sentinel events in patients undergoing one-lung ventilation in major thoracic surgery: A prospective observational 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 |
Priya Ranganathan |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room 210, 2nd Floor, Main Building, Department of Anaesthesia, Tata Memorial Hospital, Ernest Borges Road, Parel,Mumbai,MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224177000 |
| Fax |
|
| Email |
drpriyaranganathan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya Ranganathan |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room 210, 2nd Floor, Main Building, Department of Anaesthesia, Tata Memorial Hospital, Ernest Borges Road, Parel,Mumbai,MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224177000 |
| Fax |
|
| Email |
drpriyaranganathan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanay Tekade |
| Designation |
Post graduate student |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room 210, 2nd Floor, Main Building, Department of Anaesthesia, Tata Memorial Hospital, Ernest Borges Road, Parel,Mumbai,MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7028298830 |
| Fax |
|
| Email |
tekadetanay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Ernest Borges Road, Parel, Mumbai 400012 |
| 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 Priya Ranganathan |
Tata Memorial Hospital |
Room 210, Department of Anaesthesia, 2nd Floor, Main Building, Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
24177000
drpriyaranganathan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing one-lung ventilation.
2. Age – 18YRS AND ABOVE
3. Sex – Both
|
|
| ExclusionCriteria |
| Details |
Cases for which data is missing
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of perioperative sentinel events with 6 clinical indicators in patients undergoing one lung ventilation. |
During the intra-operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between age, gender, ASA status, type of lung isolation device used and the incidence of sentinel events. |
During the intra-operative period. |
|
|
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)
|
15/03/2025 |
| 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="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
|
Patients undergoing thoracic surgery
often need lung isolation and one-lung ventilation to allow surgical access and
control of ventilation. Lung isolation is achieved by using either double-lumen
tubes or bronchial blockers. However, the this may be associated with events
such as inability to place the lung isolation device, intra-operative hypoxemia,
hemodynamic instability and cardiac arrhythmias, and intra-operative
malposition of the device. This study will review medical records of patients
undergoing major thoracic surgeries and analyse such sentinel events.The
study period will be for 6 months during which we will look at the data of
approximately 150 patients undergoing one lung ventilation in major thoracic surgery.
There will be no direct patient contact and data will be obtained from
electronic medical records. |