To Compare Endotracheal Tube (ET) With Subglottic Suction Drainage and Standard ET in the Incidence of VAP
Primary Purpose
Ventilator-Associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SSD tube
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator-Associated Pneumonia
Eligibility Criteria
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
Sites / Locations
- Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SSD Arm
Standard Arm
Arm Description
In the SSD arm, the patients will be intubated with an endotracheal tube with suglottic suction drainage (SSD tube)
In the standard arm, the patients will be intubated with the standard endotracheal tube which does not have subglottic suction.
Outcomes
Primary Outcome Measures
Incidence of Ventilator Associated Pneumonia
To assess the role of endotracheal tube with subglottic suction drainage on incidence of VAP as compared to standard ET tube
Incidence of airway colonization
Assess the incidence of airway colonization during the period of endotracheal intubation
Secondary Outcome Measures
Full Information
NCT ID
NCT03101202
First Posted
March 24, 2017
Last Updated
January 19, 2019
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT03101202
Brief Title
To Compare Endotracheal Tube (ET) With Subglottic Suction Drainage and Standard ET in the Incidence of VAP
Official Title
Comparison of Endotracheal Tube With Subglottic Suction Drainage With Standard Endotracheal Tube in the Incidence of Airway Colonization and Ventilator Associated Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 16, 2016 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Ventilator Associated Pneumonia (VAP) is associated with increased hospitalisation, increased health care cost and high morbidity and mortality. The incidence of VAP increases with duration of mechanical ventilation. There is limited data especially from India on the incidence of VAP and also the role of subglottic aspiration in its prevention. The aim of this study is to determine the role of subglottic suction in the incidence of VAP.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-Associated Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SSD Arm
Arm Type
Experimental
Arm Description
In the SSD arm, the patients will be intubated with an endotracheal tube with suglottic suction drainage (SSD tube)
Arm Title
Standard Arm
Arm Type
No Intervention
Arm Description
In the standard arm, the patients will be intubated with the standard endotracheal tube which does not have subglottic suction.
Intervention Type
Device
Intervention Name(s)
SSD tube
Intervention Description
The SSD tube allows the suction of subglottic secretions that collect above the cuff of the endotracheal tube
Primary Outcome Measure Information:
Title
Incidence of Ventilator Associated Pneumonia
Description
To assess the role of endotracheal tube with subglottic suction drainage on incidence of VAP as compared to standard ET tube
Time Frame
28 days
Title
Incidence of airway colonization
Description
Assess the incidence of airway colonization during the period of endotracheal intubation
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijay N Nongpiur, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Compare Endotracheal Tube (ET) With Subglottic Suction Drainage and Standard ET in the Incidence of VAP
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