| CTRI Number |
CTRI/2024/04/066342 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Patients in ICU with pneumonia who are on ventilator machine, they will undergo a procedure (bronchoscopy) and a sample of lung secretion will be taken and sent for laboratory examination |
|
Scientific Title of Study
|
Study of microbiological isolates and antibiotic susceptibility patterns in suspected cases of ventilator-associated pneumonia with bronchoscopy-based surveillance technique in ICU |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sadaf Chishti |
| Designation |
PG resident |
| Affiliation |
School of medical sciences and research sharda university |
| Address |
Department of Anaesthesiology
School of medical sciences and research sharda university
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7780839240 |
| Fax |
|
| Email |
iamsadafchishti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Murti Sharma |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research sharda university |
| Address |
Department of Anaesthesiology
School of medical sciences and research sharda university
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7798881243 |
| Fax |
|
| Email |
sharmarammurti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram Murti Sharma |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research sharda university |
| Address |
Department of Anaesthesiology
School of medical sciences and research sharda university
Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
7798881243 |
| Fax |
|
| Email |
sharmarammurti@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Medical Sciences and Research Sharda University Greater Noida U.P-201310 |
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology
School of Medical Sciences and Research Sharda University Gautam Budh Nagar 201301 UP |
| Type of Sponsor |
Private medical college |
|
|
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 Sadaf Chishti |
School of medical sciences and research sharda university Greater Noida U.P |
ICU 2ND FLOOR SHARAD HOSPITAL, School of medical sciences and research sharda university
Gautam Buddha Nagar
UTTAR PRADESH |
7780839240
iamsadafchishti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of MedicalScience And Research, Sharda University, Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bronchoscopy |
Patients admitted in ICU on ventilator will be examined by the treating intensivist on daily basis. On clinical suspicion of ventilator-associated pneumonia (VAP), a flexible fibre-optic bronchoscope will be used to perform bronchoscopy and collect broncho-alveolar lavage (BAL) sample. This intervention will be completed in 15 minutes. The collected sample will be sent to microbiology laboratory for culture and antibiotic sensitivity. This study will help to identify the bacteria causing ventilator-associated pneumonia and their antibiotic sensitivity pattern and provide treatment by using appropriate antibiotics. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with a clinical suspicion of ventilator associated pneumonia
2.Mechanically ventilated for more than 48 hours
3.Age 18 years and above
4.Both genders |
|
| ExclusionCriteria |
| Details |
1.Patients with a clinical suspicion of ventilator associated pneumonia
2.Mechanically ventilated for more than 48 hours
3.Age 18 years and above
4.Both genders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To identify microbes associated with ventilator-associated pneumonia & examine
their antibiotic sensitivity patterns.
2.To identify multi-drug resistant & extensive drug-resistant organisms
prevalent in ICU.
3. To correlate Clinical Pulmonary Infection Score values with ventilator associated pneumonia |
in duration 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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)
|
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
|
Ventilator-associated pneumonia (VAP) is a hospital-acquired lung infection that occurs in
patients, who are mechanically ventilated for at least 48 hours, either through tracheostomy or
endotracheal intubation.1,2 It is divided into early (within 4 days after mechanical ventilation)
and late (from the fifth day onwards).2 This disease is the second most common nosocomial
infection in intensive care unit patients.3,4 The microbial causes of ventilator-associated
pneumonia vary considerably by geographic location and over time. The most common
pathogens involved in ventilator-associated pneumonia are bacteria including E.coli, Klebsiella
(gram-negative bacilli) and Staphylococcus aureus (gram-positive coccus). There are various
other causative organisms like Pseudomonas species and Acinetobacter species that are
resistant to different antibiotics and are referred to as multidrug-resistant (MDR) species4,5 As
per standardized international terminology created by European Centre for Disease Control
(ECDC) and Centre for Disease Control & Prevention (CDC), Atlanta, the multidrug-resistant
(MDR) and extensively drug-resistant (XDR) have been well defined. The term MDR or
multidrug-resistant bacteria denotes those bacteria that have acquired resistance to one or more
agents within three or more antimicrobial categories. Extensively drug-resistant (XDR)
bacteria denote those that have acquired resistance to at least one antimicrobial agent in all but
two antimicrobial categories. VAP is suspected in patients with clinical signs of infection, such
as at least two of the following criteria: new onset of fever, purulent endotracheal secretions,
leucocytosis or leukopenia, increase in minute ventilation, decline in oxygenation and/or
increased need for vasopressors to maintain blood pressure.
The risk factors associated with ventilator-associated pneumonia include the duration of
mechanical ventilation, underlying lung disease, infection, acute respiratory distress syndrome,
neurological disorder, trauma, prior antibiotic usage and red cell transfusion6
. VAP is believed
to occur in 8% to 28% of mechanically ventilated patients.
2,7 The incidence of VAPattributable mortality is difficult to quantify due to the possible confounding effect of
associated conditions, but VAP is thought to increase the mortality of the underlying disease
by about 30%.
8 VAP is also associated with considerable morbidity, including prolonged ICU
length of stay, prolonged mechanical ventilation and increased costs of hospitalization.
Flexible fibre-optic bronchoscopy is a routinely used invasive diagnostic procedure employed
for the diagnosis of various pulmonary diseases and aids in their adequate management. In
patients with ventilator-associated pneumonia, bronchoscopy has a diagnostic as well as
2
therapeutic role. This includes aspiration of retained secretions & mucous plugs, administration
of drugs and bronchoalveolar lavage. One major technical problem with all bronchoscopic
techniques is the proper selection of the sampling area in the tracheobronchial tree. Usually,
the sampling area is selected based on the location of the infiltrate on the chest radiograph or
the segment visualized during bronchoscopy having purulent secretions9
. In case of doubt and
because autopsy studies indicate that ventilator-associated pneumonia frequently involves the
posterior portion of the right lower lobe, this area should probably be sampled on priority.10
The risk inherent in bronchoscopy appears slight even in critically ill patients requiring
mechanical ventilation, although the associated occurrence of cardiac arrhythmias, hypoxemia,
or bronchospasm is not unusual.
Microbiological analysis samples from the lower respiratory tract can be obtained by
bronchoalveolar lavage, protected-specimen brush and direct lung aspirates. Among these
techniques, bronchoalveolar lavage provides the most accurate representation of the bacterial
burden in the lungs.11 Bronchoalveolar lavage (BAL) has been shown to be reliable for the
identification of microorganisms present in the lung specimens of patients with bacterial
pneumonia.12,13
Bronchoalveolar lavage ( |