Comparison of the efficacy and safety of cuffed versus uncuffed endotracheal tubes for infants in the intensive care setting: a pilot, unblinded RCT

Author(s):  
Rebecca E Thomas ◽  
Simon Erickson ◽  
Bruce Hullett ◽  
Corrado Minutillo ◽  
Martyn Lethbridge ◽  
...  

ObjectiveTo study effectiveness and safety of cuffed versus uncuffed endotracheal tubes (ETTs) in small infants in the intensive care unit (ICU).DesignPilot RCT.SettingNeonatal and paediatric ICUs of children’s hospital in Western Australia.ParticipantsSeventy-six infants ≥35 weeks gestation and infants <3 months of age, ≥3 kg.InterventionsPatients randomly assigned to Microcuff cuffed or Portex uncuffed ETT.Main outcomes measuresPrimary outcome was achievement of optimal ETT leak in target range (10%–20%). Secondary outcomes included: reintubations, ventilatory parameters, ventilatory complications, postextubation complications and long-term follow-up.ResultsSuccess rate (achievement of mean leak in the range 10%–20%) was 13/42 (30.9%) in the cuffed ETT group and 6/34 (17.6%) in uncuffed ETT group (OR=2.09; 95% CI (0.71 to 6.08); p=0.28). Mean percentage time within target leak range in cuffed ETT group 28% (IQR: 9–42) versus 15% (IQR: 0–28) in uncuffed ETT group (p=0.01). There were less reintubations to optimise size in cuffed ETT group 0/40 versus 10/36 (p<0.001). No differences were found in gaseous exchange, ventilator parameters or postextubation complications. There were fewer episodes of atelectasis in cuffed ETT group 0/42 versus 4/34 (p=0.03). No patient had been diagnosed with subglottic stenosis at long-term follow-up.ConclusionsThere was no difference in the primary outcome, though percentage time spent in optimal leak range was significantly higher in cuffed ETT group. Cuffed ETTs reduced reintubations to optimise ETT size and episodes of atelectasis. Cuffed ETTs may be a feasible alternative to uncuffed ETTs in this group of patients.Trial registration numberACTRN12615000081516.

2012 ◽  
Vol 7 (1) ◽  
pp. 30 ◽  
Author(s):  
Nalan Adıgüzel ◽  
Zuhal Karakurt ◽  
Gökay Güngör ◽  
ÖzlemYazıcıoğlu Moçin ◽  
Merih Balcı ◽  
...  

2021 ◽  
Author(s):  
Márcio Mossmann ◽  
Marco Vugman Wainstein ◽  
Stéfani Mariani ◽  
Guilherme Pinheiro Machado ◽  
Gustavo Neves Araujo ◽  
...  

Abstract BACKGROUND Interleukin-6 (IL-6) is an inflammation-related cytokine associated with an elevated risk of cardiovascular events. In a previous study, we demonstrated that increased IL-6 was predictive of sub-clinical atherosclerotic coronary disease in intermediate-risk patients undergoing coronary angiography. In the present study, we investigated whether increased serum IL-6 is predictive of cardiovascular events in high-risk patients. METHODS In this observational study, consecutive patients referred for elective coronary angiography due to stable chest pain/myocardial ischemia had IL-6 measured immediately before the procedure. Long-term follow-up was performed by phone call or e-mail, and their clinical registries were revised. The primary outcome was a composite of new myocardial infarction, new ischemic stroke, hospitalization due to heart failure, new coronary revascularization, cardiovascular death, and death due to all causes. RESULTS From the 141 selected patients, 100 completed the IL-6 analysis and were followed for a mean of 5.5 years. The median age was 61.1 years, 44% were men, and 61% had type-2 diabetes. The median overall time-to-event for the primary outcome was 297 weeks (95% confidence interval [CI] = 266.95–327.16). A receiver operator characteristic curve defined the best cut-off value of baseline serum IL-6 (0.44 pg/mL) with sensitivity (84.37%) and specificity (38.24%) to define two groups. High IL-6 level was moderately predictive of cardiovascular events. ( p for interaction = 0.015) (hazard ratio = 2.81; 95% CI = 1.38–5.72, p=0.01). The subgroup analysis did not find interactions between patients with or without diabetes, obesity, or hypertension. CONCLUSION This preliminary study indicates that, in high-risk symptomatic patients undergoing elective coronary angiography, increased pre-procedure serum levels of IL-6 predicted long-term cardiovascular outcomes. These results were similar irrespective of diabetes, hypertension, or obesity status. IL-6 must be studied in larger long-term follow-up studies as a potential tool to re-classify patients with increased cardiovascular risk.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Francisco Pérez-Gómez ◽  
Ramón Bover ◽  
Antonio Salvador ◽  
María Paz Maluenda ◽  
Susana Asenjo ◽  
...  

The NASPEAF trial showed that combined anticoagulant plus antiplatelet therapy was more effective than anticoagulant alone at reducing vascular events in atrial fibrillation (AF) patients. We planned both to validate this benefit during a longer follow-up of patients included in that trial and to assess the hypothesis that combination of anticoagulation plus different antiplatelets could be differently effective and/or safe in patients from that trial and new ones followed-up for at least one year. Methods: Five hundred and seventy-four AF patients were included. Anticoagulation alone therapy (INR 2.0 –3.0) was used as control group (g) 1 to compare with anticoagulation (1.9 –2.5) plus either trifusal 600 mg/d (g2), trifusal 300 mg/d (g3) or aspirin 100 mg/d (g4). Median follow-up was 50, 32, 50 and 37 months respectively. The primary outcome was a composite of ischemic/haemorrhagic stroke, systemic/coronary ischemic events and cardiovascular death. The incidence of severe bleeding was also collected. Anticoagulation was regularly controlled in dedicated units. Results: Long-term follow-up showed benefit of combined anticoagulant plus trifusal 600 mg/d vs anticoagulant alone (primary outcome 2.86% pt/years in g1 vs 1.36% in g2, P=0.014). Combined therapy using other antiplatelet strategies was less effective or safe due to higher incidence of ischemic events when using trifusal 300 mg/d (2.44% pt/years in g3 vs 0.61% in g2, P=0.031) as well as more severe bleeding events with aspirin 100 mg/d (6.60% pt/years in g4 vs 1.51% in g2, P=0.008). Groups g1, g3 and g4 had similar primary outcome (2.86% pt/years, 2.67% and 2.83% respectively). Mean INR and other anticoagulation parameters were similar in the three combined therapy groups. Non-gastric severe bleeding incidence during combined therapy with trifusal 600 mg/d (0.3% pt/years) was lower than that observed in either anticoagulant alone therapy (2.1%, P=0.012) or combined with aspirin (6.60%, P=0.008). In conclusion, long-term follow-up of the NASPEAF trial confirmed the benefit of combined antithrombotic therapy over anticoagulant alone therapy. Combined therapy with aspirin 100 mg/d instead of trifusal 600 mg/d caused higher incidence of severe bleeding.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E B Martins ◽  
W Hueb ◽  
E G Lima ◽  
P C Rezende ◽  
C L Garzillo ◽  
...  

Abstract Background The evaluation of coronary disease by SYNTAX score I (SSI) is used to grade coronary complexity. Following SSI, two other scores were developed: SYNTAX score II (SSII) and residual SYNTAX score (rSS). Nevertheless, there is still a lack of evidence about the prognostic significance of these scores among patients undergoing CABG. Purpose Our aim was to evaluate the relation of the SSI, SSII and rSS score with outcomes in a long-term follow-up after elective CABG. Methods This is a single center, registry-based study. Baseline SSI was calculated from patients undergoing CABG by interventional cardiologists. SSI results were considered as usual: <23, 23–32 and >32. SSII and rSRR were then calculated and categorized in tertiles: <21.4, 21.4–29.4 and >29.4 for SSII and 0, 1–5 and >5 for rSS. Primary outcome was a composite of overall death, myocardial infarction, additional revascularization, or stroke (MACCE). Results Data were obtained from 559 patients. Median follow-up was 6 years (IQR: 4.9–9.8) and 170 events were documented. The Kaplan-Meier curves (figure 1) showed significant differences of MACCE in higher SSI, SSII and rSS (p=0.039, 0.033, <0.001 respectively). After multivariate adjustment, rSS, ejection fraction (EF) and age were found to be independent predictors of MACCE (p<0.001, 0.034 and 0.006, respectively). Figure 1 Conclusion In this sample SSI, II and residual were associated with the occurrence of events. However, just the rSS remained an independent predictor of MACCE together with age and EF.


2016 ◽  
Vol 22 (5) ◽  
pp. 250-256 ◽  
Author(s):  
Holly J. Roberts ◽  
Rabecca M. Harris ◽  
Caroline Krehbiel ◽  
Brea Banks ◽  
Barbara Jackson ◽  
...  

2021 ◽  
Author(s):  
Véronique Bos ◽  
Daniëlle Roorda ◽  
Eleonore de Sonnaville ◽  
Menne van Boven ◽  
Jaap Oosterlaan ◽  
...  

Abstract Background: In complex neonatal and paediatric clinical practice, little is known about long-term patient outcomes and what follow-up care is most valuable for patients. Emma Children’s Hospital, Amsterdam UMC (Netherlands), implemented a follow-up programme called Follow Me for neonatal and paediatric patient groups, to gain more insight into long-term outcomes and to use such outcomes to implement a learning cycle for clinical practice, improve follow-up care and facilitate research. Three departments initiated re-engineering and change processes. Each introduced multidisciplinary approaches to long-term follow-up, including regular standardised check-ups for defined age groups, based on medical indicators, developmental progress, and psychosocial outcomes in patients and their families. This research evaluates the implementation of the three follow-up programmes, comparing predefined procedures (work-as-imagined) with how the programmes were implemented in practice (work-as-done). Methods: This study was conducted in 2019–2020 in the outpatient settings of the neonatal intensive care, paediatric intensive care and paediatric surgery departments of Emma Children’s Hospital. It focused on the organisational structure of the follow-up care. The functional resonance analysis method (FRAM) was applied, using documentary analysis, semi-structured interviews, observations and feedback sessions.Results: One work-as-imagined model and four work-as-done models were described. The results showed vast data collection on medical, developmental and psychosocial indicators in all work-as-done models; however, process indicators for programme effectiveness and performance were missing. In practice there was a diverse allocation of roles and responsibilities and their interrelations to create a multidisciplinary team; there was no one-size-fits-all. Although control and feedback loops for long-term outcomes were specified with respect to the follow-up groups within the programmes, they were found to overlap and misalign with other internal and external long-term outcome monitoring practices. Conclusion: Implementing structured long-term follow-up may provide insights for improving daily practice and follow-up care, with the precondition of standardised measurements. Lessons learned from practice are (1) to address fragmentation in data collection and storage, (2) to incorporate the diverse ways to create a multidisciplinary team in practice, and (3) to include timely actionable indicators on programme effectiveness and performance, alongside medical, developmental and psychosocial indicators.


2004 ◽  
Vol 26 (6) ◽  
pp. 626-632 ◽  
Author(s):  
Raymond G. Morris ◽  
Michelle Y. Y. Lee ◽  
Xenia Cleanthous ◽  
Andrew B. Black

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