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

Air-impingement Manipulation to Clear Subglottic Secretion to Prevent Ventilator Associated Pneumonia in Prolonged Intubated Patients：a Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02632539

Enrollment

220

Registered

2015-12-16

Start date

2016-01-31

Completion date

2018-12-31

Last updated

2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

ventilator associated pneumonia, Subglottic Secretion Drainage, manual air-impingement operation

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.

Interventions

PROCEDUREManual air-impingement operation

A method which we invented to clear subglottic secretion

PROCEDUREsubglottic secretion drainage

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage of participants with ventilator-associated pneumonia	Up to 28 days

Secondary

Measure	Time frame
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

Other

Measure	Time frame
Invasive ventilation duration	Participants will be followed for the duration of invasive ventilation, an expected average of 7-10 days

Contacts

Primary ContactJiwei Li

15010589613@163.com86-15010589613

Backup ContactBing Sun

ricusunbing@126.com86-13911151075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026