Ventilator-Associated PneumoniaNCT03101202
To Compare Endotracheal Tube (ET) With Subglottic Suction Drainage and Standard ET in the Incidence of VAP
A study testing SSD tube in people with Ventilator-Associated Pneumonia, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Associated Pneumonia
- What is being tested?
- SSD tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 16 Jul 2016to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years
- Requiring orotracheal intubation and mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Comparison of Endotracheal Tube With Subglottic Suction Drainage With Standard Endotracheal Tube in the Incidence of Airway Colonization and Ventilator Associated Pneumonia
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.
Read the 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
- Conditions
- Ventilator-Associated Pneumonia
- Being tested
- SSD tube
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSD tubeDevice
The SSD tube allows the suction of subglottic secretions that collect above the cuff of the endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| SSD Arm | Experimental | In the SSD arm, the patients will be intubated with an endotracheal tube with suglottic suction drainage (SSD tube) Receives: Device: SSD tube |
| Standard Arm | No intervention | In the standard arm, the patients will be intubated with the standard endotracheal tube which does not have subglottic suction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Incidence of airway colonization
Assess the incidence of airway colonization during the period of endotracheal intubation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start16 Jul 2016
- Primary completion31 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijay Noel Nongpiur, All India Institute of Medical Sciences
- Investigators
- Vijay N Nongpiur, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101202
- Sponsor's protocol ID
- IECPG-464/27.07.2016
- Status last verified
- Jan 2019
- First submitted
- 24 Mar 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endotracheal Tube With Subglottic Suction Drainage With Standard Endotracheal Tube in the Incidence of Airway Colonization and Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT03101202
- Acronym / sponsor ID
- IECPG-464/27.07.2016
- Conditions
- Ventilator-Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 16 Jul 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSD Arm | Experimental | Device: SSD tubeIn the SSD arm, the patients will be intubated with an endotracheal tube with suglottic suction drainage (SSD tube) |
| Standard Arm | No intervention | –In the standard arm, the patients will be intubated with the standard endotracheal tube which does not have subglottic suction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18 years
- Requiring orotracheal intubation and mechanical ventilation
Key exclusion criteria (6 listed)
- Patients intubated outside the hospital
- Patient extubated within 72 hours
- Patient already on tracheostomy
- Death occurring within 72 hours
- Pneumonia developing within 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSD tubeThe SSD tube allows the suction of subglottic secretions that collect above the cuff of the endotracheal tube | Device | SSD Arm |
Primary outcome
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
Incidence of airway colonization
Time frame: 28 days
Assess the incidence of airway colonization during the period of endotracheal intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay N Nongpiur, MD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSD tube in people with Ventilator-Associated Pneumonia, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ventilator Associated Pneumonia (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.