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

December 12, 2015 updated by: Jiwei LI, Beijing Chao Yang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: subglottic secretion drainage
The conventional method which we use subglottic secretion drainage to clear subglottic secretion
Procedure: subglottic secretion drainage
The conventional method which we use subglottic secretion drainage to clear subglottic secretion
Experimental: Manual air-impingement operation
A method which we invented to clear subglottic secretion
Procedure: Manual air-impingement operation
A method which we invented to clear subglottic secretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with ventilator-associated pneumonia
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with ventilator-associated event
Time Frame: Up to 28 days
Up to 28 days
ICU mortality
Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks
Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Jiwei Li, Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

December 12, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

December 16, 2015

Last Update Submitted That Met QC Criteria

December 12, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCYH-RCCM-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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