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

Ventilator Associated Pneumonia Clinical Trial

Official title:

Air-impingement Manipulation to Clear Subglottic Secretion to Prevent Ventilator Associated Pneumonia in Prolonged Intubated Patients：a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02632539
• Other study ID #: BJCYH-RCCM-01
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 14, 2015
• Last updated: December 12, 2015
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2015
• Source: Beijing Chao Yang Hospital
• Contact: Jiwei Li
• Phone: 86-15010589613
• Email: 15010589613[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Procedure:
• Manual air-impingement operation
A method which we invented to clear subglottic secretion
• subglottic secretion drainage
The conventional method which we use subglottic secretion drainage to clear subglottic secretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

References & Publications (9)

Bouza E, Pérez MJ, Muñoz P, Rincón 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):938-46. doi: 10.1378/ — View 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 randomi — View 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 20 — View 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. Review. — View 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. — View Citation

Lorente L, Lecuona M, Jiménez 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. Epub 2007 Sep 13. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Invasive ventilation duration		Participants will be followed for the duration of invasive ventilation, an expected average of 7-10 days	No
Primary	Percentage of participants with ventilator-associated pneumonia		Up to 28 days	Yes
Secondary	Percentage of participants with ventilator-associated event		Up to 28 days	Yes
Secondary	ICU mortality		Participants will be followed for the duration of ICU stay, an expected average of 4 weeks	No

External Links

•   Continuous aspiration of subglottic secretions in the prevention of ventilator-associated pneumonia in the postoperative period of major heart surgery.
•   Effect of two methods of subglottic secretion drainage on the incidence of ventilator-associated pneumonia
•   Evidence-based assessment of diagnostic tests for ventilator-associated pneumonia.Executive summary
•   Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia.
•   Intermittent subglottic secretion drainage may cause tracheal damage in patients with few oropharyngeal secretions.
•   Measures to prevent nosocomial infections during mechanical ventilation.
•   Prevention of ventilator-associated pneumonia and ventilator-associated conditions: a randomized controlled trial with subglottic secretion suctioning.
•   Subglottic secretion drainage for preventing ventilator associated pneumonia: a meta-analysis.
•   Ventilator-associated pneumonia: is zero possible?