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

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: Ventilator Associated Pneumonia

Treatments: Procedure: Manual air-impingement operation; Procedure: subglottic secretion drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT02632539

BJCYH-RCCM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

subglottic secretion drainage

Active Comparator group

Description:

The conventional method which we use subglottic secretion drainage to clear subglottic secretion

Treatment:

Procedure: subglottic secretion drainage

Manual air-impingement operation

Experimental group

Description:

A method which we invented to clear subglottic secretion

Treatment:

Procedure: Manual air-impingement operation