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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventilator Associated Pneumonia

Intervention / Treatment
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* Procedure: Manual air-impingement operation
* Device: subglottic secretion drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: subglottic secretion drainage<br>The conventional method with a special tube to drainage subglottic secretion | Procedure: Manual air-impingement operation<br>* A method which we invented to clear subglottic secretion<br>|
| Experimental: Manual air-impingement operation<br>A method which we invented to clear subglottic secretion | Device: subglottic secretion drainage<br>* The conventional method with a special tube to drainage subglottic secretion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with ventilator-associated pneumonia |  | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality |  | Participants will be followed for the duration of ICU stay, an expected average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subglottic secretion drainage, manual air-impingement operation, prolonged intubation, ventilator associated pneumonia