Berra Lorenzo, Kolobow Theodor, Laquerriere Patrice, Pitts Betsey, Bramati Simone, Pohlmann Joshua, Marelli Chiara, Panzeri Miriam, Brambillasca Pietro, Villa Federico, Baccarelli Andrea, Bouthors Sylvie, Stelfox Henry T, Bigatello Luca M, Moss Joel, Pesenti Antonio
Anesthesia and Critical Care, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA.
Intensive Care Med. 2008 Jun;34(6):1030-7. doi: 10.1007/s00134-008-1100-1. Epub 2008 Apr 17.
Coated medical devices have been shown to reduce catheter-related infections. We coated endotracheal tubes (ETT) with silver sulfadiazine (SSD), and tested them in a clinical study to assess the feasibility, safety, and efficacy of preventing bacterial colonization.
A prospective, randomized clinical trial, phase I-II.
Academic intensive care unit (ICU).
Forty-six adult patients expected to need 12-24 h of intubation were randomized into two groups.
Patients were randomized to be intubated with a standard non-coated ETT (St-ETT, n=23; control group), or with a SSD-coated ETT (SSD-ETT, n=23).
Coating with SSD prevented bacterial colonization of the ETT (frequency of colonization: SSD-ETT 0/23, St-ETT 8/23; p<0.01). No organized bacterial biofilm could be identified on the lumen of any ETT; however, SSD was associated with a thinner mucus layer (in the SSD-ETT secretion deposits ranged from 0 to 200 microm; in the St-ETT deposits ranged between 50 and 700 microm). No difference was observed between the two groups in the tracheobronchial brush samples (frequency of colonization: SSD-ETT 0/23, St-ETT 2/23; p=0.48). No adverse reactions were observed with the implementation of the novel device.
SSD-ETT can be safely used in preventing bacterial colonization and narrowing of the ETT in patients intubated for up to 24 h (mean intubation time 16 h).
已证明带涂层的医疗器械可减少导管相关感染。我们用磺胺嘧啶银(SSD)涂覆气管内导管(ETT),并在一项临床研究中对其进行测试,以评估预防细菌定植的可行性、安全性和有效性。
一项前瞻性、随机临床试验,I-II期。
学术重症监护病房(ICU)。
46名预计需要进行12 - 24小时插管的成年患者被随机分为两组。
患者被随机分配使用标准的无涂层ETT(St-ETT,n = 23;对照组)或SSD涂覆的ETT(SSD-ETT,n = 23)进行插管。
SSD涂层可预防ETT的细菌定植(定植频率:SSD-ETT为0/23,St-ETT为8/23;p<0.01)。在任何ETT的管腔内均未发现有组织的细菌生物膜;然而,SSD与较薄的黏液层相关(SSD-ETT中分泌物沉积范围为0至200微米;St-ETT中沉积范围为50至700微米)。两组在气管支气管刷检样本中的情况无差异(定植频率:SSD-ETT为0/23,St-ETT为2/23;p = 0.48)。使用该新型器械未观察到不良反应。
SSD-ETT可安全用于预防插管长达24小时(平均插管时间16小时)患者的ETT细菌定植和狭窄。