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

Not Applicable

• Conditions: Ventilator Associated Pneumonia
• Interventions: Device: subglottic secretion drainage; Procedure: Manual air-impingement operation

• Registration Number: NCT02032849
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Study Timeline

• Study First Submitted: 2013-12-30
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Study Start: 2014-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual air-impingement operation	subglottic secretion drainage	A method which we invented to clear subglottic secretion
subglottic secretion drainage	Manual air-impingement operation	The conventional method with a special tube to drainage subglottic secretion

Primary Outcome Measures

Name	Time	Method
Percentage of participants with ventilator-associated pneumonia	Up to 28 days

Secondary Outcome Measures

Name	Time	Method
ICU mortality	Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

Trial Locations

Locations (1)

Beijing Chaoyang hospital; 🇨🇳 Beijing, Beijing, China