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

Ventilator Associated Pneumonia Clinical Trial

Official title:

Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients, a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02032849
• Other study ID #: BJCYHRT-001
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2013
• Last updated: August 13, 2014
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2014
• Source: Beijing Chao Yang Hospital
• Contact: Jie Li, Master
• Phone: 86-13552976483
• Email: lijie8497[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Procedure:
• Manual air-impingement operation
A method which we invented to clear subglottic secretion

Device:
• subglottic secretion drainage
The conventional method with a special tube to drainage subglottic secretion

Locations

Country	Name	City	State
China	Beijing Chaoyang hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Invasive ventilation duration		Participants will be followed for the duration of invasive ventilation, an expected average of 7-10 days	No
Primary	Percentage of participants with ventilator-associated pneumonia		Up to 28 days	Yes
Secondary	ICU mortality		Participants will be followed for the duration of ICU stay, an expected average of 4 weeks	No