Ventilator Associated PneumoniaNCT03871985
Efficacy of Two Intermittent Subglottic Secretion
A study testing Subglottic secretion lavage combined with aspiration and Subglottic secretion aspiration in people with Ventilator Associated Pneumonia, run by The First Hospital of Jilin University.
Trial summary
The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Subglottic secretion lavage combined with aspiration and Subglottic secretion aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2019to 15 Jan 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)
Who cannot join
- Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and
About this study
Official title: Efficacy of Intermittent Subglottic Secretion Lavage Combined With Aspiration Preventing Ventilator Associated Pneumonia in Patients With Severe Neurological Disease：A Single-center Randomized Controlled Trial
The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease
Read the detailed description
Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation. Many studies have shown that the accumulation of subglottic secretions above the endotracheal cuff plays an important role in the pathogenesis of VAP. Subglottic secretion drainage (SSD) has been shown to be associated with a lower incidence of VAP in previous meta-analyses. Most studies in past reported that in the group of patients in whom endotracheal tube (ETT) was used and subglottic secretion drainage was applied compared to the group without subglottic secretion drainage.Very few studies compared two different methods of SSD,such as subglottic secretion lavage combined with aspiration or pure aspiration.The tubes need frequent cleaning as they often get blocked, especially the draining duct. This may be the reason why they are not commonly applied. However,subglottic secretion lavage combined with aspiration can reduce the incidence of tube blockage.So The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Subglottic secretion lavage combined with aspiration, Subglottic secretion aspiration
- Keywords
- ventilator-associated pneumonia, subglottic secretion drainage, endotracheal tube, length of mechanical ventilation
- 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.
Subglottic secretion lavage combined with aspirationProcedure or surgery
Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion lavage combined with aspiration was performed every 4 hours: Underwent preoxygenation before cuff pressure checking, and was maintained between 30 and 35 cmH2O. After aspirating secretions from the mouth, nose, and airway, 2-5 mL distilled sterile water was instilled through the subglottic lumen, and then the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat lavage and aspiration until the irrigation fluid is clear. After washing, cuff pressure checking and was maintained between 25 and 30 cmH2O.
Subglottic secretion aspirationProcedure or surgery
Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion aspiration was performed every 4 hours:Underwent preoxygenation before cuff pressure checking ,and was maintained between 25 and 30 cmH2O. After aspirating secretions from the mouth, nose, and airway, the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat suction until the secretion is completely absorbed.
| Study group | Role | What they receive |
|---|---|---|
| Lavage combined with aspiration | Experimental | Intermittent subglottic secretions lavage combined with aspiration Receives: Procedure: Subglottic secretion lavage combined with aspiration |
| Pure aspiration | Active comparator | Intermittent subglottic secretions aspiration Receives: Procedure: Subglottic secretion aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator-associated pneumonia
is pneumonia that occurs when an artificial airway is established and mechanically ventilated
Measured: through study completion, an average of 10 months
Secondary outcomes (1)
Incidence of draining duct blockage
If mucus flow stopped during subglottic suctioning with a sudden increase of the negative pressure in the proximal port of the suction suggesting a probable occlusion
Measured: through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start15 Mar 2019 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion15 Jan 2020 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871985
- Sponsor's protocol ID
- SSD-SSLACA
- Status last verified
- Dec 2018
- First submitted
- 19 Feb 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intermittent Subglottic Secretion Lavage Combined With Aspiration Preventing Ventilator Associated Pneumonia in Patients With Severe Neurological Disease：A Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03871985
- Acronym / sponsor ID
- SSD-SSLACA
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- ventilator-associated pneumonia, subglottic secretion drainage, endotracheal tube, length of mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 12 Mar 2019 (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.
The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease
Detailed description
Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation. Many studies have shown that the accumulation of subglottic secretions above the endotracheal cuff plays an important role in the pathogenesis of VAP. Subglottic secretion drainage (SSD) has been shown to be associated with a lower incidence of VAP in previous meta-analyses. Most studies in past reported that in the group of patients in whom endotracheal tube (ETT) was used and subglottic secretion drainage was applied compared to the group without subglottic secretion drainage.Very few studies compared two different methods of SSD,such as subglottic secretion lavage combined with aspiration or pure aspiration.The tubes need frequent cleaning as they often get blocked, especially the draining duct. This may be the reason why they are not commonly applied. However,subglottic secretion lavage combined with aspiration can reduce the incidence of tube blockage.So The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavage combined with aspiration | Experimental | Procedure: Subglottic secretion lavage combined with aspirationIntermittent subglottic secretions lavage combined with aspiration |
| Pure aspiration | Active comparator | Procedure: Subglottic secretion aspirationIntermittent subglottic secretions aspiration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)
Key exclusion criteria (1 listed)
- Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and
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 |
|---|---|---|
| Subglottic secretion lavage combined with aspirationVentilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion lavage combined with aspiration was performed every 4 hours: Underwent preoxygenation before cuff pressure checking, and was maintained between 30 and 35 cmH2O. After aspirating secretions from the mouth, nose, and airway, 2-5 mL distilled sterile water was instilled through the subglottic lumen, and then the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat lavage and aspiration until the irrigation fluid is clear. After washing, cuff pressure checking and was maintained between 25 and 30 cmH2O. | Procedure or surgery | Lavage combined with aspiration |
| Subglottic secretion aspirationVentilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion aspiration was performed every 4 hours:Underwent preoxygenation before cuff pressure checking ,and was maintained between 25 and 30 cmH2O. After aspirating secretions from the mouth, nose, and airway, the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat suction until the secretion is completely absorbed. | Procedure or surgery | Pure aspiration |
Primary outcome
Incidence of ventilator-associated pneumonia
Time frame: through study completion, an average of 10 months
is pneumonia that occurs when an artificial airway is established and mechanically ventilated
1 secondary outcome
Incidence of draining duct blockage
Time frame: through study completion, an average of 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
Related trials for Ventilator Associated Pneumonia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Subglottic secretion lavage combined with aspiration and Subglottic secretion aspiration in people with Ventilator Associated Pneumonia, run by The First Hospital of Jilin University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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: through study completion, an average of 10 months). 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 12 Mar 2019.