Clinical trial NCT02632539: Air-impingement Manipulation to Clear Subglottic Secretion to Prevent VAP in Prolonged Intubated Patients
Official title: Air-impingement Manipulation to Clear Subglottic Secretion to Prevent Ventilator Associated Pneumonia in Prolonged Intubated Patients：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ventilator Associated Pneumonia
Keywords: ventilator associated pneumonia
Subglottic Secretion Drainage
manual air-impingement operation
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of participants with ventilator-associated pneumonia
timeFrame: Up to 28 days
Secondary outcomes:
measure: Percentage of participants with ventilator-associated event
timeFrame: Up to 28 days
measure: ICU mortality
timeFrame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
Other outcomes:
measure: Invasive ventilation duration
timeFrame: Participants will be followed for the duration of invasive ventilation, an expected average of 7-10 days
Locations:
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Jiwei Li
role: PRINCIPAL_INVESTIGATOR
References:
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