ABSTRACT
OBJECTIVE: Few randomized trials have evaluated the use of non-invasive ventilation (NIV) for early acute respiratory failure (ARF) in non-intensive care unit (ICU) wards. The aim of this study is to test the hypothesis that early NIV for mild-moderate ARF in non-ICU wards can prevent development of severe ARF. DESIGN: Pragmatic, parallel group, randomized, controlled, multicenter trial. SETTING: Non-intensive care wards of tertiary centers. PATIENTS: Non-ICU ward patients with mild to moderate ARF without an established indication for NIV. INTERVENTIONS: Patients will be randomized to receive or not receive NIV in addition to best available care. MEASUREMENTS AND MAIN RESULTS: We will enroll 520 patients, 260 in each group. The primary endpoint of the study will be the development of severe ARF. Secondary endpoints will be 28-day mortality, length of hospital stay, safety of NIV in non-ICU environments, and a composite endpoint of all in-hospital respiratory complications. CONCLUSIONS: This trial will help determine whether the early use of NIV in non-ICU wards can prevent progression from mild-moderate ARF to severe ARF.
Subject(s)
Noninvasive Ventilation/methods , Respiratory Insufficiency/therapy , Acute Disease , Adolescent , Adult , Age Factors , Aged , Comorbidity , Disease Progression , Female , Hospital Mortality , Humans , Length of Stay , Male , Middle Aged , Research Design , Sex Factors , Tertiary Care Centers , Young AdultABSTRACT
AIM: The purpose of this study was to examine the influence of aneurysm size on early outcome in women undergoing abdominal aortic aneurysm (AAA) repair, with suggestion of lowered threshold for intervention. PATIENTS AND METHODS: Retrospective cohort study on the early outcome of 25 females undergoing elective endovascular (EVAR) and open AAA repair, compared to 340 males from 2005 to 2017. The study was focused on 30-days mortality (primary endpoint) and incidence of non fatal major adverse events - MAE (secondary endpoint) of two subgroups of women: AAA diameter <50 mm (n.14, group F1), AAA diameter ≥ 50mm (n.11, group F2). RESULTS: The incidence of the primary endpoint at 30 days was 4% in females, and 1.1% in males, respectively (p=ns). Similarly, females showed a higher rate of MAE compared to males (16% vs 9.4%, p=ns). Women who underwent surgery with small aneurysms (F1 group) had an early outcome similar to men (30-day death 0% vs 1.1%, p=ns; MAE 7.1% vs 9.4%, p=ns) and significantly better than women with larger aneurysms (30-day death 0% vs 9%, p=ns; MAE 7.1% vs 27.2, p=ns). CONCLUSIONS: Although poorly significant from a statistical point of view, the present report seems to confirm that the AAA diameter is a relevant marker of disease severity in women, assuming that repair at smaller size may be associated with less comorbidity and better outcome. KEY WORDS: Abdominal aortic aneurysm, Abdominal aortic aneurys open repair, Endovascular aortic aneurysm repair, Female gender.
