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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

220

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Jan 2016

Typical duration for phase_3

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

August 14, 2015

Completed

4 months until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed

16 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed

Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

August 14, 2015

Last Update Submit

December 12, 2015

Conditions

Ventilator Associated Pneumonia

Keywords

ventilator associated pneumoniaSubglottic Secretion Drainagemanual air-impingement operation

Outcome Measures

Primary Outcomes (1)

Percentage of participants with ventilator-associated pneumonia
Up to 28 days

Secondary Outcomes (2)

Percentage of participants with ventilator-associated event
Up to 28 days
ICU mortality
Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

Other Outcomes (1)

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

Study Arms (2)

subglottic secretion drainage

ACTIVE COMPARATOR

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

Procedure: subglottic secretion drainage

Manual air-impingement operation

EXPERIMENTAL

A method which we invented to clear subglottic secretion

Procedure: Manual air-impingement operation

Interventions

Manual air-impingement operationPROCEDURE

A method which we invented to clear subglottic secretion

Manual air-impingement operation

subglottic secretion drainagePROCEDURE

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

subglottic secretion drainage

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Beijing Chao Yang Hospitallead

Related Publications (9)

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.
PMID: 10816031RESULT
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.
PMID: 25343570RESULT
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.
PMID: 20936977RESULT
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.
PMID: 23583261RESULT
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.
PMID: 22186217RESULT
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.
PMID: 23727136RESULT
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.
PMID: 17872488RESULT
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.
PMID: 24969718RESULT
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.
PMID: 18641114RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Jiwei Li
Beijing Chao Yang Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiwei Li

CONTACT

86-15010589613 15010589613@163.com

Bing Sun

CONTACT

86-13911151075 ricusunbing@126.com

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: RRT-NPS

Study Record Dates

First Submitted

August 14, 2015

First Posted

December 16, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 16, 2015

Record last verified: 2015-12

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (2)

subglottic secretion drainage

Manual air-impingement operation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (9)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Other Outcomes (1)

Study Arms (2)

subglottic secretion drainage

Manual air-impingement operation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (9)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates