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

NCT ID: NCT02632539

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Ventilator Associated Pneumonia

Keywords

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ventilator associated pneumonia Subglottic Secretion Drainage manual air-impingement operation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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subglottic secretion drainage

The conventional method which we use subglottic secretion drainage to clear subglottic secretion

Group Type ACTIVE_COMPARATOR

subglottic secretion drainage

Intervention Type PROCEDURE

The conventional method which we use subglottic secretion drainage to clear subglottic secretion

Manual air-impingement operation

A method which we invented to clear subglottic secretion

Group Type EXPERIMENTAL

Manual air-impingement operation

Intervention Type PROCEDURE

A method which we invented to clear subglottic secretion

Interventions

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Manual air-impingement operation

A method which we invented to clear subglottic secretion

Intervention Type PROCEDURE

subglottic secretion drainage

The conventional method which we use subglottic secretion drainage to clear subglottic secretion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

* PEEP≥10cmH2O or FiO2≥0.8;
* unstable hemodynamics;
* severe bulla and pneumothorax;
* enrolled in other study;
* cuff leak test is positive.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiwei LI

RRT-NPS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiwei Li

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Central Contacts

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Jiwei Li

Role: CONTACT

Phone: 86-15010589613

Email: [email protected]

Bing Sun

Role: CONTACT

Phone: 86-13911151075

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 10816031 (View on PubMed)

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.

Reference Type RESULT
PMID: 25343570 (View on PubMed)

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.

Reference Type RESULT
PMID: 20936977 (View on PubMed)

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.

Reference Type RESULT
PMID: 23583261 (View on PubMed)

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.

Reference Type RESULT
PMID: 22186217 (View on PubMed)

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.

Reference Type RESULT
PMID: 23727136 (View on PubMed)

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.

Reference Type RESULT
PMID: 17872488 (View on PubMed)

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.

Reference Type RESULT
PMID: 24969718 (View on PubMed)

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.

Reference Type RESULT
PMID: 18641114 (View on PubMed)

Related Links

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http://journal.publications.chestnet.org.proxy1.lib.uwo.ca/data/Journals/CHEST/21944/177S.pdf

Evidence-based assessment of diagnostic tests for ventilator-associated pneumonia.Executive summary

http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/25343570

Prevention of ventilator-associated pneumonia and ventilator-associated conditions: a randomized controlled trial with subglottic secretion suctioning.

http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/20936977

Ventilator-associated pneumonia: is zero possible?

http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/23583261

Subglottic secretion drainage for preventing ventilator associated pneumonia: a meta-analysis.

http://www-ncbi-nlm-nih-gov.proxy1.lib.uwo.ca/pubmed/22186217

Measures to prevent nosocomial infections during mechanical ventilation.

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.

Continuous aspiration of subglottic secretions in the prevention of ventilator-associated pneumonia in the postoperative period of major heart surgery.

Other Identifiers

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BJCYH-RCCM-01

Identifier Type: -

Identifier Source: org_study_id