- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03101202
To Compare Endotracheal Tube (ET) With Subglottic Suction Drainage and Standard ET in the Incidence of VAP
Comparison of Endotracheal Tube With Subglottic Suction Drainage With Standard Endotracheal Tube in the Incidence of Airway Colonization and Ventilator Associated Pneumonia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be enrolled following inclusion-exclusion criteria
- Base line clinical and laboratory data will be recorded in a pre designed proforma.
- Endotracheal aspirate will be taken at the time of enrollment and day3, day5, day7 and then weekly till patient is on mechanical ventilation.
Data collection
For each patient following data will be recorded as per the proforma.
During Hospitalization
All eligible patients will be carefully followed up for signs of VAP during hospitalization.
Apart from clinical examination, regular recording of body temperature, observance of tracheal aspirate appearance, leukocyte counts and chest radiograph will be done.
VAP Diagnosis: Based on American College of Chest Physicians (ACCP) criteria:
An association of a new or progressive consolidation on chest radiograph Plus at least two of the following variables
- fever > 38 degree
- leucocytosis ( > 12000) or leucopenia ( <4000)
- purulent secretions
At VAP Diagnosis
Patients who diagnosed as cases VAP, based on the above criteria.
Non-bronchoscopic bronchoalveolar lavage (BAL) will be done for microbiological sampling. In patients where clinically indicated, Flexible bronchoscopy and Bronchoalveolar lavage, sampling will be done. At the time of VAP diagnosis blood culture and urine culture, will also be sent.
Sample Collection
Endotracheal aspiration
A sterile 22 inch, 12 French suction catheter with a mucus extractor will be introduced at least 30 cm and minimum of 5ml sample will be collected. Endotracheal aspirate cultures will be examined semi quantitatively. Bacterial and antibiotic susceptibility tests will be performed.
Non bronchoscopic protected BAL
Specimen will be collected by sputum suction trap. A 47-48 cm sterile suction catheter of 16fr will be inserted through endotracheal tube till it meets resistance and will be wedged there.Then a 50cm long 8fr sterile suction catheter will be passed through it till it meets resistance and specimen will be taken. 20ml of NS instilled, minimum of 5ml aspirate will be collected. If aspirate is less than 5 ml it will be repeated.
Bronchoscopic BAL
Consent will be taken from the legal guardian. The patient will receive adequate sedation; short-acting paralytic agent to prevent coughing during the procedure Will be considered if necessary. The endotracheal tube will be ≥ 1.5 mm larger than the external diameter of the flexible bronchoscope. The patients will receive a fraction of inspired oxygen (FiO2) of 100%, and positive-end expiratory pressure will be reduced as much as tolerated. To maximize ventilation and minimize air trapping, the peak inspiratory flow will be decreased to ≤60 liters/min, the respiratory rate set between 10 and 20 breaths/ min, and the peak inspiratory pressure alarm increased. The patient will be carefully monitored throughout the procedure. The sampling area will be chosen based on the location of the infiltrate on chest X-ray.
Microbiological analysis
All the samples were subjected to Gram staining and microscopic examination and were cultured on sheep blood agar, chocolate agar and MacConkey agar semi quantitatively and 104/ml CFU was considered significant. Isolated strains were identified by standard microbiological techniques and the antimicrobial susceptibility testing were performed by disc diffusion method as per CLSI guidelines. The Gram negative bacilli were tested against the following antibiotics:amikacin, amoxicillin-clavulanate, cefotaxime, ceftazidime, ciprofloxacin, cefaperazone-sulbactam, meropenem ,imipenem, netilimicin, Piperacillin-tazobactum. Additionally colistin and ertapenem will be tested when appropriate. Gram positive organisms will be tested for amikacin, netilmicin, cotrimoxazole, ceftazidime, ciprofloxacin,cefoperazone-sulbactam, penicillin, linezolid, erythromycin, vancomycin and teicoplanin
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
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New Delhi, Delhi, India, 110029
- Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age more than 18 years
- Requiring orotracheal intubation and mechanical ventilation
Exclusion Criteria:
- Patients intubated outside the hospital
- Patient extubated within 72 hours
- Patient already on tracheostomy
- Death occurring within 72 hours
- Pneumonia developing within 48 hours
- Patient/relatives not giving consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SSD Arm
In the SSD arm, the patients will be intubated with an endotracheal tube with suglottic suction drainage (SSD tube)
|
The SSD tube allows the suction of subglottic secretions that collect above the cuff of the endotracheal tube
|
No Intervention: Standard Arm
In the standard arm, the patients will be intubated with the standard endotracheal tube which does not have subglottic suction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Ventilator Associated Pneumonia
Time Frame: 28 days
|
To assess the role of endotracheal tube with subglottic suction drainage on incidence of VAP as compared to standard ET tube
|
28 days
|
Incidence of airway colonization
Time Frame: 28 days
|
Assess the incidence of airway colonization during the period of endotracheal intubation
|
28 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vijay N Nongpiur, MD, All India Institute of Medical Sciences, New Delhi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IECPG-464/27.07.2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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