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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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subglottic secretion drainage

The conventional method with a special tube to drainage subglottic secretion

Group Type ACTIVE_COMPARATOR

Manual air-impingement operation

Intervention Type PROCEDURE

A method which we invented to clear subglottic secretion

Manual air-impingement operation

A method which we invented to clear subglottic secretion

Group Type EXPERIMENTAL

subglottic secretion drainage

Intervention Type DEVICE

The conventional method with a special tube to drainage subglottic secretion

Interventions

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Manual air-impingement operation

A method which we invented to clear subglottic secretion

Intervention Type PROCEDURE

subglottic secretion drainage

The conventional method with a special tube to drainage subglottic secretion

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No