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

Primary Purpose

Ventilator Associated Pneumonia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Manual air-impingement operation

subglottic secretion drainage

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring ventilator associated pneumonia, subglottic secretion drainage, manual air-impingement operation, prolonged intubation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Beijing Chaoyang hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

subglottic secretion drainage

Manual air-impingement operation

Arm Description

The conventional method with a special tube to drainage subglottic secretion

A method which we invented to clear subglottic secretion

Outcomes

Primary Outcome Measures

Percentage of participants with ventilator-associated pneumonia

Secondary Outcome Measures

ICU mortality

Full Information

NCT ID

NCT02032849

First Posted

December 30, 2013

Last Updated

August 13, 2014

Sponsor

Beijing Chao Yang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02032849

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Chao Yang Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator Associated Pneumonia

Keywords

ventilator associated pneumonia, subglottic secretion drainage, manual air-impingement operation, prolonged intubation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

subglottic secretion drainage

Arm Type

Active Comparator

Arm Description

The conventional method with a special tube to drainage subglottic secretion

Arm Title

Manual air-impingement operation

Arm Type

Experimental

Arm Description

A method which we invented to clear subglottic secretion

Intervention Type

Procedure

Intervention Name(s)

Manual air-impingement operation

Intervention Description

A method which we invented to clear subglottic secretion

Intervention Type

Device

Intervention Name(s)

subglottic secretion drainage

Intervention Description

The conventional method with a special tube to drainage subglottic secretion

Primary Outcome Measure Information:

Title

Percentage of participants with ventilator-associated pneumonia

Time Frame

Up to 28 days

Secondary Outcome Measure Information:

Title

ICU mortality

Time Frame

Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

Other Pre-specified Outcome Measures:

Title

Invasive ventilation duration

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Li, Master

Phone

86-13552976483

lijie8497@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sun Bing

Phone

86-13911151075

ricusunbing@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Li, Master

Organizational Affiliation

Beijing Chao Yang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Chaoyang hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie Li, Master

Phone

86-13552976483

cyhrt@sina.cn

First Name & Middle Initial & Last Name & Degree

Bing Sun, Doctor

Phone

86-13911151075

ricusunbing@gmail.com

First Name & Middle Initial & Last Name & Degree

Jie Li, Master

12. IPD Sharing Statement

Citations:

PubMed Identifier

34165661

Citation

Li Y, Yuan X, Sun B, Li HC, Chu HW, Wang L, Zhao Y, Tang X, Wang R, Li XY, Tong ZH, Wang C. Rapid-flow expulsion maneuver in subglottic secretion clearance to prevent ventilator-associated pneumonia: a randomized controlled study. Ann Intensive Care. 2021 Jun 24;11(1):98. doi: 10.1186/s13613-021-00887-5.

Results Reference

derived

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

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