| CTRI Number |
CTRI/2023/12/060665 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Pilot study |
| Study Design |
Other |
|
Public Title of Study
|
Study of microbes present in the lung and abdomen in sick patients admitted in Intensive Care unit
|
|
Scientific Title of Study
|
Correlation of lung and gut microbiome of critically ill patients: A Cross-Sectional 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 Choro Athiphro Kayina |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room No 5011 Teaching Block
Department of Anaesthesiology Pain Medicine and Critical Care
Ansari Nagar AIIMS
New Delhi 110029
South
DELHI
110029
India |
| Phone |
9654116228 |
| Fax |
|
| Email |
kayinaathiphro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Choro Athiphro Kayina |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room No 5011 Teaching Block
Department of Anaesthesiology Pain Medicine and Critical Care
Ansari Nagar AIIMS
New Delhi 110029
South
DELHI
110029
India |
| Phone |
9654116228 |
| Fax |
|
| Email |
kayinaathiphro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Choro Athiphro Kayina |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Room No 5011 Teaching Block
Department of Anaesthesiology Pain Medicine and Critical Care
Ansari Nagar AIIMS
New Delhi 110029
South
DELHI
110029
India |
| Phone |
9654116228 |
| Fax |
|
| Email |
kayinaathiphro@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar
AIIMS, New Delhi - 110029
|
| 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 Choro Athiphro Kayina |
All India Institute of Medical Sciences New Delhi |
Room No 5012, Teaching block, 5th Floor, Department of Anaesthesia Pain Medicine and Critical Care
South
DELHI |
9654116228
kayinaathiphro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee All India Institute of Medical Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Admitted in Intensive care unit intubated and on mechanical ventilation will be included in this study.
|
|
| ExclusionCriteria |
| Details |
i) Patients who desaturate during routine endotracheal suctioning
ii) Fraction of inspired oxygen (FiO2) >0.80
iii) Positive end expiratory pressure (PEEP) > 10 cm H2O
iv) Prone position
v) Thrombocytopenia (platelet count <50,000) or coagulopathy (INR >1.5)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correlate the microbiome of the lung & gut in critically ill intubated patients on day 5 of ICU admission using metagenomic analysis.
|
Day 5 of ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analyse the predominant microbiome composition in the lung & the gut. |
Day 5 of ICU stay |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/01/2024 |
| 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="2"
Months="0"
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
|
In critically ill patients requiring mechanical ventilation due to any cause, micro-aspiration is believed to be responsible for respiratory infection, thus the development of “ventilator bundles†such as oral care, head of bed-elevation, airway suction and aspiration prophylaxis. Regardless of these interventions, pneumonia continues to be a complication in Intensive Care Unit (ICU) patients with high mortality. Our study data will help understand if lung is enriched with the gut microbiome in intubated patients admitted in ICU. Understanding these correlations between the lung and gut microbiome in critically ill patients may have potential role in the development of new treatment strategies. |