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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
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (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

    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

    First Posted
    August 14, 2015
    Last Updated
    December 12, 2015
    Sponsor
    Beijing Chao Yang Hospital
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    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.

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

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