Author, year | Materials tested | Study design | Pcuff | Outcomes | Main results |
---|---|---|---|---|---|
Lucangelo, 2008 [14] | • PU-cuffed ETT, cylindrical shape (Mallinckrodt SealGuard, Mallinckrodt Medical, Cornamady, Anthlone County, Ireland) • PVC-cuffed ETT, spindle-like shape (Mallinckrodt Hi-Lo, Mallinckrodt Medical, Cornamady, Anthlone County, Ireland) | • RCT • 2 groups of 20 ICU patients requiring immediate orotracheal intubation and mechanical ventilation because of deterioration of consciousness (GCS score ≤8) • Ventilatory settings: VC ventilation with VT 8–9 ml/kg and respiratory rate to maintain normocapnia, and PEEP (5 cmH2O) • 5 h postintubation, PEEP was removed • Oral and tracheal secretions were not aspirated during experiment | • 30 cmH2O • Controlled with aneroid manometer | • Evans blue (1 ml) diluted in normal saline (1 ml) • Bronchoscopic evaluation to detect blue dye in trachea at 1 h and 5 h postintubation (with PEEP) and hourly thereafter until 12 h postintubation (without PEEP) • As soon as blue spot was seen on trachea caudal to ETT tip, experiment was finished | • 5 h postintubation, leakage observed in 2 patients in PVC group • At 6th hour (1 h after PEEP removal), leakage observed in all patients in PVC group • In the PU group, first leakage occurred after 8 h; at end of experiment (12th hour), fluid leakage absent in 3 patients • Difference between the 2 groups (log-rank test on Kaplan-Meier survival curves) was statistically significant (p < 0.001) |
Poelaert, 2008 [30] | • PU-cuffed ETT, cylindrical shape (SealGuard, Covidien, Mansfield, Mass, USA) • PVC-cuffed ETT, cylindrical shape (standard Mallinckrodt, Mallinckrodt Inc. Hazelwood, Mo, USA) • Female patients: ID 8 mm • Male patients: ID 9 mm | • RCT, single-blind • 2 groups of 67 patients scheduled for cardiac surgery • Intraoperative antibiotic prophylaxis with cefazolin 2 g 3 times daily for 24 h | • 20–26 cmH2O • Controlled immediately after intubation, at closure of sternum, on arrival at ICU, and every 4 h during postoperative course | • Early postoperative pneumonia (until 7 days postoperatively) • Nosocomial pneumonia was defined as all of the following:  - New/evolving infiltrate on chest x-ray  - Temperature > 38.2 °C  - Leukocytosis (>12000 cells/mm3)  - Presence of purulent sputum/endotracheal aspirate  - Increase in C-reactive protein for 2 consecutive postoperative days  - Deterioration in PaO2/FiO2 ratio ≥20 % • Diagnosis: assessor blinded | • Rate of postoperative pneumonia in PU group significantly lower than PVC group (23 % vs. 42 %; p = 0.026) • In multivariate regression analysis, use of PU-cuffed ETTs appeared to be protective for early postoperative pneumonia (OR 0.31, 95 % CI 0.13–0.77) |
Nseir, 2010 [40] | • PU-cuffed ETT, cylindrical shape (MICROCUFF, Kimberly-Clark, Zaventem, Belgium) • PVC-cuffed ETT, cylindrical shape (Mallinckrodt Hi-Lo Lanz, Mallinckrodt Medical, Athlone, Ireland) | • Prospective, observational trial in ICU patients • PVC group (patients included in first 6 months of study, n = 26); PVC group (patients included in second period of 6 months, n = 22) • Patients observed during 24 h with continuous monitoring of Pcuff • After 24 h, tracheal suctioning to obtain aspirate sample for pepsin measurement • Pepsin levels considered positive at 200 ng/ml | • 25 cmH2O • Manually adjusted every 8 h | • Pepsin in tracheal secretions (ng/ml) used as proxy for microaspiration of gastric contents • Recorded 24 h postintubation | • No difference in Pcuff variation observed between groups • Pepsin levels lower among patients with PU-cuffed ETTs (217 ± 126 ng/ml) than in PVC group (408 ± 282 ng/ml) • Pepsin levels >200 ng/ml more common in PVC group (69 % vs. 27 %; p = 0.008) • Pepsin levels >300 ng/ml more common in PVC group (61 % vs. 22 %; p = 0.009) |
Miller, 2011 [32] | • PU-cuffed ETT, cylindrical shape (MICROCUFF, Kimberly-Clark Corporation, Roswell, GA, USA) • PVC-cuffed ETT, cylindrical shape (conventional type) | • Before-after study with interrupted time-series analysis • 1 hospital, 5 ICUs • Retrospective comparison of VAP rates in respective periods • 1 year of observation with PVC-cuffed tubes before intervention • 1 year of observation with PU-cuffed ETTs • 3 months postintervention observation (return to conventional PVC-cuffed ETTs) | Not reported | • VAP rates expressed per 1000 ventilation days • VAP diagnosed on basis of clinical or microbiologic criteria, based on CDC’s National Healthcare Safety Network standard definition [29] | • Baseline year of observation (PVC-cuffed ETT): 37 VAP episodes (5.3/1000 ventilation days) • Intervention year (PU-cuffed ETT): 21 VAP episodes (2.8/1000 ventilation days) (p = 0.0138) • After return to PVC-cuffed ETTs, 6 episodes in 3 months (3.5/1000 ventilation days) • Incidence risk ratio of VAP during intervention year 0.57 (95 % CI 0.34–0.96) |
Philippart, 2015 [31] | • PU-cuffed ETT, cylindrical shape (MICROCUFF, Kimberly-Clark, Irving, Tx, USA) • PVC-cuffed ETT, cylindrical shape (Hi-Lo, Covidien, Dublin, Ireland) • PU-cuffed ETT, conical shape (SealGuard, Covidien, Dublin, Ireland) • PVC-cuffed ETT, conical shape (TaperGuard, Covidien, Dublin, Ireland) • ID 7.5 or 8 mm | • Multicenter RCT, 4 study arms • PU cylindrical group (n = 123) • PVC cylindrical group (n = 129) • PU conical group (n = 153) • PVC conical group (n = 129) At study inclusion, no important differences between groups were observed | • 25–30 cmH2O • Manually controlled with manometer every 6 h • Airway management standardized across study sites | • Primary endpoint: bacterial colonization of the trachea (103 CFU/ml) at days 1, 2, 3, 7 • Secondary endpoint: cumulative VAP rate during ICU stay, defined on basis of clinical, biological and radiological patterns [41]; bacterial cultures sampled in all patients suspected of having VAP and confirmed if quantitative culture was at least 104 CFU/ml | • No differences in tracheal colonization (at >103, >104, >105, or >106 CFU/ml) were observed 48 h postintubation (p > 0.05, p value indicates difference across 4 groups) • VAP rate between PU cylindrical and PVC cylindrical group not different (resp. 17.1 % vs. 10.8 %; p = 0.202) • VAP rate between PU conical and PVC conical group not different (respectively 16.3 % vs. 13.2 %; p = 0.505) • No difference in VAP rate observed when both PU groups and both PVC groups were pooled (respectively 16.6 % vs. 12.0 %; p = 0.140) |