Air-impingement Manipulation to Clear Subglottic Secretion to Prevent VAP in Prolonged Intubated Patients
Primary Purpose
Ventilator Associated Pneumonia
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Manual air-impingement operation
subglottic secretion drainage
Sponsored by
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
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.
Sites / Locations
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 which we use subglottic secretion drainage to clear 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
Percentage of participants with ventilator-associated event
ICU mortality
Full Information
NCT ID
NCT02632539
First Posted
August 14, 2015
Last Updated
December 12, 2015
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02632539
Brief Title
Air-impingement Manipulation to Clear Subglottic Secretion to Prevent VAP in Prolonged Intubated Patients
Official Title
Air-impingement Manipulation to Clear Subglottic Secretion to Prevent Ventilator Associated Pneumonia in Prolonged Intubated Patients:a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
subglottic secretion drainage
Arm Type
Active Comparator
Arm Description
The conventional method which we use subglottic secretion drainage to clear 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
Procedure
Intervention Name(s)
subglottic secretion drainage
Intervention Description
The conventional method which we use subglottic secretion drainage to clear 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
Percentage of participants with ventilator-associated event
Time Frame
Up to 28 days
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
Accepts Healthy Volunteers
No
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
Jiwei Li
Phone
86-15010589613
Email
15010589613@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Sun
Phone
86-13911151075
Email
ricusunbing@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiwei Li
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
10816031
Citation
Grossman RF, Fein A. Evidence-based assessment of diagnostic tests for ventilator-associated pneumonia. Executive summary. Chest. 2000 Apr;117(4 Suppl 2):177S-181S. doi: 10.1378/chest.117.4_suppl_2.177s. No abstract available.
Results Reference
result
PubMed Identifier
25343570
Citation
Damas P, Frippiat F, Ancion A, Canivet JL, Lambermont B, Layios N, Massion P, Morimont P, Nys M, Piret S, Lancellotti P, Wiesen P, D'orio V, Samalea N, Ledoux D. Prevention of ventilator-associated pneumonia and ventilator-associated conditions: a randomized controlled trial with subglottic secretion suctioning. Crit Care Med. 2015 Jan;43(1):22-30. doi: 10.1097/CCM.0000000000000674.
Results Reference
result
PubMed Identifier
20936977
Citation
Klompas M. Ventilator-associated pneumonia: is zero possible? Clin Infect Dis. 2010 Nov 15;51(10):1123-6. doi: 10.1086/656738. Epub 2010 Oct 11. No abstract available.
Results Reference
result
PubMed Identifier
23583261
Citation
Frost SA, Azeem A, Alexandrou E, Tam V, Murphy JK, Hunt L, O'Regan W, Hillman KM. Subglottic secretion drainage for preventing ventilator associated pneumonia: a meta-analysis. Aust Crit Care. 2013 Nov;26(4):180-8. doi: 10.1016/j.aucc.2013.03.003. Epub 2013 Apr 11.
Results Reference
result
PubMed Identifier
22186217
Citation
Ramirez P, Bassi GL, Torres A. Measures to prevent nosocomial infections during mechanical ventilation. Curr Opin Crit Care. 2012 Feb;18(1):86-92. doi: 10.1097/MCC.0b013e32834ef3ff.
Results Reference
result
PubMed Identifier
23727136
Citation
Suys E, Nieboer K, Stiers W, De Regt J, Huyghens L, Spapen H. Intermittent subglottic secretion drainage may cause tracheal damage in patients with few oropharyngeal secretions. Intensive Crit Care Nurs. 2013 Dec;29(6):317-20. doi: 10.1016/j.iccn.2013.02.007. Epub 2013 May 31.
Results Reference
result
PubMed Identifier
17872488
Citation
Lorente L, Lecuona M, Jimenez A, Mora ML, Sierra A. Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1079-83. doi: 10.1164/rccm.200705-761OC. Epub 2007 Sep 13.
Results Reference
result
PubMed Identifier
24969718
Citation
Tao Z, Zhao S, Yang G, Wang L, Zhu S. [Effect of two methods of subglottic secretion drainage on the incidence of ventilator-associated pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2014 Apr;37(4):283-6. Chinese.
Results Reference
result
PubMed Identifier
18641114
Citation
Bouza E, Perez MJ, Munoz P, Rincon C, Barrio JM, Hortal J. Continuous aspiration of subglottic secretions in the prevention of ventilator-associated pneumonia in the postoperative period of major heart surgery. Chest. 2008 Nov;134(5):938-946. doi: 10.1378/chest.08-0103. Epub 2008 Jul 18.
Results Reference
result
Links:
URL
http://journal.publications.chestnet.org.proxy1.lib.uwo.ca/data/Journals/CHEST/21944/177S.pdf
Description
Evidence-based assessment of diagnostic tests for ventilator-associated pneumonia.Executive summary
URL
http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/25343570
Description
Prevention of ventilator-associated pneumonia and ventilator-associated conditions: a randomized controlled trial with subglottic secretion suctioning.
URL
http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/20936977
Description
Ventilator-associated pneumonia: is zero possible?
URL
http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/23583261
Description
Subglottic secretion drainage for preventing ventilator associated pneumonia: a meta-analysis.
URL
http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/22186217
Description
Measures to prevent nosocomial infections during mechanical ventilation.
URL
http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/?term=Intermittent+subglottic+secretion+drainage+may+cause+tracheal+damage+in+patients+with+few+oropharyngeal+secretions
Description
Intermittent subglottic secretion drainage may cause tracheal damage in patients with few oropharyngeal secretions.
URL
http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/?term=Influence+of+an+endotracheal+tube+with+polyurethane+cuff+and+subglottic+secretion+drainage+on+pneumonia.
Description
Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia.
URL
http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/?term=Effect+of+tow+methods+of+subglottic+secretion+drainage+on+the+incidence+of+ventilator-associated+pneumonia.
Description
Effect of two methods of subglottic secretion drainage on the incidence of ventilator-associated pneumonia
URL
http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/?term=Continuous+aspiration+of+subglottic+secretions+in+the+prevention+of+ventilator-associated+pneumonia+in+the+postoperative+period+of+major+heart+surgery.
Description
Continuous aspiration of subglottic secretions in the prevention of ventilator-associated pneumonia in the postoperative period of major heart surgery.
Learn more about this trial
Air-impingement Manipulation to Clear Subglottic Secretion to Prevent VAP in Prolonged Intubated Patients
We'll reach out to this number within 24 hrs