Ventilator Associated PneumoniaNCT02032849
Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients
A study testing Manual air-impingement operation and subglottic secretion drainage in people with Ventilator Associated Pneumonia, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
This is a randomized controlled trial compared two methods to drainage subglottic secretion in prolonged intubated patients.After enrolled, patients are randomized assigned to intermittent subglottic secretion drainage group and air-impingement manipulation group. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Manual air-impingement operation and subglottic secretion drainage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Dec 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Should meet all the criteria:
- Intubation less than 24 hours before admitting respiratory intensive care unit;
- Anticipated intubation for more than 72 hours;
- Anticipated survival time is more than 2 weeks
Who cannot join
- Meet any of these criteria:
- PEEP≥10cmH2O or FiO2≥0.8;
- unstable hemodynamics;
- severe bulla and pneumothorax;
- enrolled in other study;
- cuff leak test is positive.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang hospital
Beijing, Beijing Municipality, 100020
Jie Li, Master, 86-13552976483, cyhrt@sina.cn
Bing Sun, Doctor, 86-13911151075, ricusunbing@gmail.com
About this study
Official title: Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients, a Randomized Controlled Trial.
This is a randomized controlled trial compared two methods to drainage subglottic secretion in prolonged intubated patients.After enrolled, patients are randomized assigned to intermittent subglottic secretion drainage group and air-impingement manipulation group.
Read the detailed description
Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic space is a well-proven cause of VAP. Therefore, prevention should include the aspiration of secretions from the subglottic space. Investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. This method has been granted as a patent by Chinese national intellectual property patent office, it has been used in investigators' daily work for more than 10 years and more than 20 Chinese ICUs have used it everyday. Investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Manual air-impingement operation, subglottic secretion drainage
- Keywords
- ventilator associated pneumonia, subglottic secretion drainage, manual air-impingement operation, prolonged intubation
- 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.
Manual air-impingement operationProcedure or surgery
A method which we invented to clear subglottic secretion
subglottic secretion drainageDevice
The conventional method with a special tube to drainage subglottic secretion
| Study group | Role | What they receive |
|---|---|---|
| subglottic secretion drainage | Active comparator | The conventional method with a special tube to drainage subglottic secretion Receives: Procedure: Manual air-impingement operation |
| Manual air-impingement operation | Experimental | A method which we invented to clear subglottic secretion Receives: Device: subglottic secretion drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with ventilator-associated pneumonia
Measured: Up to 28 days
Secondary outcomes (1)
ICU mortality
Measured: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Li, Beijing Chao Yang Hospital
- Investigators
- Jie Li, Master, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032849
- Sponsor's protocol ID
- BJCYHRT-001
- Status last verified
- Aug 2014
- First submitted
- 30 Dec 2013
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Y, Yuan X, Sun B, Li HC, Chu HW, Wang L, Zhao Y, Tang X, Wang R, Li XY, Tong ZH, Wang C. Rapid-flow expulsion maneuver in subglottic secretion clearance to prevent ventilator-associated pneumonia: a randomized controlled study. Ann Intensive Care. 2021 Jun 24;11(1):98. doi: 10.1186/s13613-021-00887-5.
PubMed 34165661
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02032849
- Acronym / sponsor ID
- BJCYHRT-001
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- ventilator associated pneumonia, subglottic secretion drainage, manual air-impingement operation, prolonged intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Jan 2014 (estimated)
- 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.
This is a randomized controlled trial compared two methods to drainage subglottic secretion in prolonged intubated patients.After enrolled, patients are randomized assigned to intermittent subglottic secretion drainage group and air-impingement manipulation group.
Detailed description
Ventilator-associated pneumonia (VAP) is the most frequent infection occurring in patients who are admitted to the ICU. The accumulation of respiratory secretions in the subglottic space is a well-proven cause of VAP. Therefore, prevention should include the aspiration of secretions from the subglottic space. Investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. This method has been granted as a patent by Chinese national intellectual property patent office, it has been used in investigators' daily work for more than 10 years and more than 20 Chinese ICUs have used it everyday. Investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subglottic secretion drainage | Active comparator | Procedure: Manual air-impingement operationThe conventional method with a special tube to drainage subglottic secretion |
| Manual air-impingement operation | Experimental | Device: subglottic secretion drainageA method which we invented to clear subglottic secretion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intubation less than 24 hours before admitting respiratory intensive care unit;
- Anticipated intubation for more than 72 hours;
- Anticipated survival time is more than 2 weeks
Key exclusion criteria (6 listed)
- PEEP≥10cmH2O or FiO2≥0.8;
- unstable hemodynamics;
- severe bulla and pneumothorax;
- enrolled in other study;
- cuff leak test is positive.
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 |
|---|---|---|
| Manual air-impingement operationA method which we invented to clear subglottic secretion | Procedure or surgery | subglottic secretion drainage |
| subglottic secretion drainageThe conventional method with a special tube to drainage subglottic secretion | Device | Manual air-impingement operation |
Primary outcome
Percentage of participants with ventilator-associated pneumonia
Time frame: Up to 28 days
1 secondary outcome
ICU mortality
Time frame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Derived from this study: PubMed 34165661Li Y, Yuan X, Sun B, Li HC, Chu HW, Wang L, Zhao Y, Tang X, Wang R, Li XY, Tong ZH, Wang C. Rapid-flow expulsion maneuver in subglottic secretion clearance to prevent ventilator-associated pneumonia: a randomized controlled study. Ann Intensive Care. 2021 Jun 24;11(1):98. doi: 10.1186/s13613-021-00887-5.
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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.
Jie Li, Master principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual air-impingement operation and subglottic secretion drainage in people with Ventilator Associated Pneumonia, run by Beijing Chao Yang Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Aug 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, Master (86-13552976483, lijie8497@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with ventilator-associated pneumonia (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02032849, which also lists 1 linked publication.
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 15 Aug 2014.