Air-impingement Manipulation to Clear Subglottic Secretion to Prevent VAP in Prolonged Intubated Patients

Phase 3

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

• Registration Number: NCT02632539
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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. Investigators invented a manual method with high-flow air produced by resuscitator to impinge secretion from the subglottic space to oral cavity. Investigators want to compare it with conventional method which uses a special intubation tube with an independent dorsal lumen to suction subglottic secretion.

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: 2015-08-14
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-12
• Last Update Submitted: 2015-12-12
• Study First Posted: 2015-12-16
• Last Update Posted: 2015-12-16
• Study Start: 2016-01
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual air-impingement operation	Manual air-impingement operation	A method which we invented to clear subglottic secretion
subglottic secretion drainage	subglottic secretion drainage	The conventional method which we use subglottic secretion drainage to clear 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
Percentage of participants with ventilator-associated event	Up to 28 days
ICU mortality	Participants will be followed for the duration of ICU stay, an expected average of 4 weeks