| CTRI Number |
CTRI/2023/09/057440 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of therapeutic bronchoscopy in critically ill patients in terms of oxygenation and ventilatory mechanics |
|
Scientific Title of Study
|
Effect of therapeutic bronchoscopy in critically ill patients in terms of oxygenation and respiratory mechanics |
| 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 Deepak malviya |
| Designation |
Head of department |
| Affiliation |
Dr Ram manohar lohia institute of medical sciences , Lucknow |
| Address |
Department of anesthesia and CCM, Dr Ram manohar lohia institute of medical sciences,Vibhuti Khand, Gomti Nagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007863 |
| Fax |
|
| Email |
drdm58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak malviya |
| Designation |
Head of department |
| Affiliation |
Dr Ram manohar lohia institute of medical sciences , Lucknow |
| Address |
Department of anesthesia and CCM, Dr Ram manohar lohia institute of medical sciences,Vibhuti Khand, Gomti Nagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007863 |
| Fax |
|
| Email |
drdm58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupender sharma |
| Designation |
Junior resident |
| Affiliation |
Dr Ram manohar lohia institute of medical sciences , Lucknow |
| Address |
Room no. 519, Dr SC Rai hostel,Dr Ram manohar lohia institute of medical sciences,Vibhuti Khand, Gomti Nagar
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8299085342 |
| Fax |
|
| Email |
srupender00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, dr ram manohar Lohia institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Anesthesia, dr ram Manohar Lohia institute of medical sciences, Lucknow, u.p. |
| 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 |
| DrRupender sharma |
Dr Ram manohar lohia institute of medical sciences |
CCU/ICU, department of anesthesia and CCM,Dr ram manohar Lohia institute of medical sciences, Gomti Nagar
Lucknow
UTTAR PRADESH |
8299085342
srupender00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committee ,RMLIMS Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Therapeutic BRONCHOSCOPY will done as a part of management in indicated icu patients and the outcome on ABG and ventilator will be seen. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Severe lung infection, poor ventilation, atelectasis on cxr/ct thorax |
|
| ExclusionCriteria |
| Details |
Age less than 18 or more than 65, hemodynamically unstable patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of therapeutic bronchoscopy in critically ill patients on mechanical ventilator in terms of oxygenation & respiratory mechanics. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post procedural complications of fibre optic bronchoscopy |
18 months |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
15/09/2023 |
| 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)
|
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
|
This is a prospective observational study planned to be done by collecting the data of patients arterial blood gases and mechanical ventilator readings before and after therapeutic bronchoscopy . procedure will be done as part of management in ICU patients. The sample size is 27 and study is planned to be complete within next 18 months. |