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Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients

Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients, a Randomized Controlled Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02032849
Enrollment
240
Registered
2014-01-10
Start date
2014-02-28
Completion date
2016-12-31
Last updated
2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

ventilator associated pneumonia, subglottic secretion drainage, manual air-impingement operation, prolonged intubation

Brief 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.

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.

Interventions

A method which we invented to clear subglottic secretion

The conventional method with a special tube to drainage subglottic secretion

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Should meet all the criteria: 1. Intubation less than 24 hours before admitting respiratory intensive care unit; 2. Anticipated intubation for more than 72 hours; 3. Anticipated survival time is more than 2 weeks

Exclusion criteria

Meet any of these criteria: 1. PEEP≥10cmH2O or FiO2≥0.8; 2. unstable hemodynamics; 3. severe bulla and pneumothorax; 4. enrolled in other study; 5. cuff leak test is positive.

Design outcomes

Primary

MeasureTime frame
Percentage of participants with ventilator-associated pneumoniaUp to 28 days

Secondary

MeasureTime frame
ICU mortalityParticipants will be followed for the duration of ICU stay, an expected average of 4 weeks

Other

MeasureTime frame
Invasive ventilation durationParticipants will be followed for the duration of invasive ventilation, an expected average of 7-10 days

Countries

China

Contacts

Primary ContactJie Li, Master
lijie8497@hotmail.com86-13552976483
Backup ContactSun Bing
ricusunbing@126.com86-13911151075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026