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

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ClinicalTrials.gov Identifier: NCT02032849
Recruitment Status : Unknown
Verified August 2014 by Jie Li, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Jie Li, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Procedure: Manual air-impingement operation Device: subglottic secretion drainage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Air-impingement Manipulation to Clear Subglottic Secretion Compared With Drainage Tube in Prolonged Intubated Patients, a Randomized Controlled Trial.
Study Start Date : February 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: subglottic secretion drainage
The conventional method with a special tube to drainage subglottic secretion
Procedure: Manual air-impingement operation
A method which we invented to clear subglottic secretion

Experimental: 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




Primary Outcome Measures :
  1. Percentage of participants with ventilator-associated pneumonia [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks ]

Other Outcome Measures:
  1. Invasive ventilation duration [ Time Frame: Participants will be followed for the duration of invasive ventilation, an expected average of 7-10 days ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032849


Contacts
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Contact: Jie Li, Master 86-13552976483 lijie8497@hotmail.com
Contact: Sun Bing 86-13911151075 ricusunbing@126.com

Locations
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China, Beijing
Beijing Chaoyang hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Jie Li, Master    86-13552976483    cyhrt@sina.cn   
Contact: Bing Sun, Doctor    86-13911151075    ricusunbing@gmail.com   
Principal Investigator: Jie Li, Master         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Principal Investigator: Jie Li, Master Beijing Chao Yang Hospital

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Responsible Party: Jie Li, RRT-NPS, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02032849     History of Changes
Other Study ID Numbers: BJCYHRT-001
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Jie Li, Beijing Chao Yang Hospital:
ventilator associated pneumonia
subglottic secretion drainage
manual air-impingement operation
prolonged intubation
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection