The routine use of pediatric airway exchange catheter after extubation of adult patients who have undergone maxillofacial or major neck surgery: a clinical observational study

INTRODUCTION: We conducted the present study to determine the usefulness of routinely inserting a pediatric airway exchange catheter (PAEC) before tracheal extubation of adult patients who had undergone maxillofacial or major neck surgery and have risk factors for difficult reintubation. METHODS: A prospective, observational and clinical study was performed in the 25-bed general intensive care unit of a university hospital. Thirty-six adult patients who underwent maxillofacial or major neck surgery and had risk factors for difficult reintubation were extubated after insertion of the PAEC. RESULTS: Four of 36 (11.1%) patients required emergency reintubation after 2, 4, 6 and 18 hours after tracheal extubation, respectively. Reintubation of these patients, which was thought to be nearly impossible by direct laryngoscopy, was easily achieved over the PAEC. CONCLUSION: The PAEC can be a life-saving device during reintubation of patients with risk factors for difficult reintubation such as laryngeo-pharyngeal oedema due to surgical manipulation or airway obstruction resulting from haematoma and anatomic changes. We therefore suggest the routine use of the PAEC in patients undergoing major maxillofacial or major neck surgery

A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients

Background: Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. Methods: We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Results: Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 μg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1-10.6%) was observed in the IC43 groups. Conclusion: This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. Trial registration: ClinicalTrials.gov, NCT00876252. Registered on 3 April 2009.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients

Background: Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. Methods: We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 mu g or 200 mu g IC43 with adjuvant, or 100 mu g IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Results: Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P = 4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 mu g IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 mu g IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1-10.6%) was observed in the IC43 groups. Conclusion: This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 mu g IC43 without adjuvant compared with 200 mu g IC43 with adjuvant, the 100 mu g dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns

A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients

Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients. We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against P. aeruginosa infections, and all-cause mortality were evaluated as secondary endpoints. Vaccinations (100 μg or 200 μg IC43 with adjuvant, or 100 μg IC43 without adjuvant, or placebo) were given twice in a 7-day interval and patients were followed up for 90 days. Higher OprF/I IgG antibody titers were seen at day 14 for all IC43 groups versus placebo (P < 0.0001). Seroconversion (≥4-fold increase in OprF/I IgG titer from days 0 to 14) was highest with 100 μg IC43 without adjuvant (80.6%). There were no significant differences in P. aeruginosa infection rates, with a low rate of invasive infections (pneumonia or bacteremia) in the IC43 groups (11.2-14.0%). Serious adverse events (SAEs) considered possibly related to therapy were reported by 2 patients (1.9%) in the group of 100 µg IC43 with adjuvant. Both SAEs resolved and no deaths were related to study treatment. Local tolerability symptoms were mild and rare (<5% of patients), a low rate of treatment-related treatment-emergent adverse events (3.1-10.6%) was observed in the IC43 groups. This phase II study has shown that IC43 vaccination of ventilated ICU patients produced a significant immunogenic effect. P. aeruginosa infection rates did not differ significantly between groups. In the absence of any difference in immune response following administration of 100 μg IC43 without adjuvant compared with 200 μg IC43 with adjuvant, the 100 μg dose without adjuvant was considered for further testing of its possible benefit of improved outcomes. There were no safety or mortality concerns. ClinicalTrials.gov, . Registered on 3 April 2009. The online version of this article (doi:10.1186/s13054-017-1601-9) contains supplementary material, which is available to authorized users

Additional file 2: of A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients

Ethics Committees. (DOCX 18 kb

Additional file 1: of A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients

Additional details on methods. (DOC 62 kb