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
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Beijing Chao Yang Hospital |
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
Not yet recruiting |
NCT04057625 -
Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
|
N/A | |
Not yet recruiting |
NCT03267693 -
Gastrointestinal Complications in Association With Oropharyngeal and Respiratory Infections in Mechanical Ventilation
|
N/A | |
Completed |
NCT00726167 -
Serum Procalcitonin Study in the Management of Ventilated Patients
|
N/A | |
Completed |
NCT02078999 -
Biomarkers in Patients Undergoing Mechanical Ventilation
|
N/A | |
Recruiting |
NCT05124977 -
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
|
N/A | |
Recruiting |
NCT05331885 -
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
|
Phase 3 | |
Completed |
NCT05517759 -
Application of VAP Bundle Among ICU Nurses
|
||
Active, not recruiting |
NCT04488510 -
Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia:
|
||
Completed |
NCT03917888 -
Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP
|
N/A | |
Not yet recruiting |
NCT06066489 -
Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns
|
N/A | |
Completed |
NCT02096328 -
Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia
|
Phase 2 | |
Terminated |
NCT00771719 -
Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia
|
Phase 1 | |
Recruiting |
NCT05696093 -
Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit
|
Phase 3 | |
Recruiting |
NCT05354778 -
HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study
|
N/A | |
Not yet recruiting |
NCT06059040 -
Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events
|
N/A | |
Completed |
NCT04563104 -
Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia
|
||
Terminated |
NCT01975350 -
Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia
|
||
Recruiting |
NCT06000761 -
Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit
|
N/A | |
Not yet recruiting |
NCT03294837 -
Treatment of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit
|
N/A |