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Importance: Supplemental oxygen is ubiquitously used in patients with COVID-19 and severe hypoxemia, but a lower dose may be beneficial. Objective: To assess the effects of targeting a Pao2 of 60 mm Hg vs 90 mm Hg in patients with COVID-19 and severe hypoxemia in the intensive care unit (ICU). Design, Setting, and Participants: Multicenter randomized clinical trial including 726 adults with COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 11 ICUs in Europe from August 2020 to March 2023. The trial was prematurely stopped prior to outcome assessment due to slow enrollment. End of 90-day follow-up was June 1, 2023. Interventions: Patients were randomized 1:1 to a Pao2 of 60 mm Hg (lower oxygenation group; n = 365) or 90 mm Hg (higher oxygenation group; n = 361) for up to 90 days in the ICU. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (mechanical ventilation, circulatory support, or kidney replacement therapy) at 90 days. Secondary outcomes included mortality, proportion of patients with serious adverse events, and number of days alive and out of hospital, all at 90 days. Results: Of 726 randomized patients, primary outcome data were available for 697 (351 in the lower oxygenation group and 346 in the higher oxygenation group). Median age was 66 years, and 495 patients (68%) were male. At 90 days, the median number of days alive without life support was 80.0 days (IQR, 9.0-89.0 days) in the lower oxygenation group and 72.0 days (IQR, 2.0-88.0 days) in the higher oxygenation group (P = .009 by van Elteren test; supplemental bootstrapped adjusted mean difference, 5.8 days [95% CI, 0.2-11.5 days]; P = .04). Mortality at 90 days was 30.2% in the lower oxygenation group and 34.7% in the higher oxygenation group (risk ratio, 0.86 [98.6% CI, 0.66-1.13]; P = .18). There were no statistically significant differences in proportion of patients with serious adverse events or in number of days alive and out of hospital. Conclusion and Relevance: In adult ICU patients with COVID-19 and severe hypoxemia, targeting a Pao2 of 60 mm Hg resulted in more days alive without life support in 90 days than targeting a Pao2 of 90 mm Hg. Trial Registration: ClinicalTrials.gov Identifier: NCT04425031.
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COVID-19 , Adulto , Humanos , Masculino , Anciano , Femenino , COVID-19/terapia , COVID-19/etiología , Oxígeno , Respiración Artificial , Terapia por Inhalación de Oxígeno/métodos , Hipoxia/etiología , Hipoxia/terapiaRESUMEN
BACKGROUND: Haloperidol is frequently used to treat delirium in patients in the intensive care unit (ICU), but evidence of its effect is limited. METHODS: In this multicenter, blinded, placebo-controlled trial, we randomly assigned adult patients with delirium who had been admitted to the ICU for an acute condition to receive intravenous haloperidol (2.5 mg 3 times daily plus 2.5 mg as needed up to a total maximum daily dose of 20 mg) or placebo. Haloperidol or placebo was administered in the ICU for as long as delirium continued and as needed for recurrences. The primary outcome was the number of days alive and out of the hospital at 90 days after randomization. RESULTS: A total of 1000 patients underwent randomization; 510 were assigned to the haloperidol group and 490 to the placebo group. Among these patients, 987 (98.7%) were included in the final analyses (501 in the haloperidol group and 486 in the placebo group). Primary outcome data were available for 963 patients (97.6%). At 90 days, the mean number of days alive and out of the hospital was 35.8 (95% confidence interval [CI], 32.9 to 38.6) in the haloperidol group and 32.9 (95% CI, 29.9 to 35.8) in the placebo group, with an adjusted mean difference of 2.9 days (95% CI, -1.2 to 7.0) (P = 0.22). Mortality at 90 days was 36.3% in the haloperidol group and 43.3% in the placebo group (adjusted absolute difference, -6.9 percentage points [95% CI, -13.0 to -0.6]). Serious adverse reactions occurred in 11 patients in the haloperidol group and in 9 patients in the placebo group. CONCLUSIONS: Among patients in the ICU with delirium, treatment with haloperidol did not lead to a significantly greater number of days alive and out of the hospital at 90 days than placebo. (Funded by Innovation Fund Denmark and others; AID-ICU ClinicalTrials.gov number, NCT03392376; EudraCT number, 2017-003829-15.).
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Antipsicóticos , Delirio , Haloperidol , Adulto , Humanos , Antipsicóticos/efectos adversos , Antipsicóticos/uso terapéutico , Cuidados Críticos , Delirio/tratamiento farmacológico , Delirio/etiología , Método Doble Ciego , Haloperidol/efectos adversos , Haloperidol/uso terapéutico , Unidades de Cuidados Intensivos , Administración IntravenosaRESUMEN
INTRODUCTION: The transition process from the intensive care unit (ICU) to hospital ward may impact the illness trajectory and compromise the continuity of safe care for ICU survivors. ICU and ward nurses are involved with the transition and are responsible for the quality of the transitional care. AIM: The aim was to explore ICU and ward nurses' views on assignments in relation to patients' transition between ICU and hospital ward. METHODS: We conducted a qualitative study with 20 semi-structured interviews with ICU nurses and ward nurses and analysed data by content analysis. SETTING: A university hospital with 690 beds and an 11-bed mixed medical/surgical ICU. FINDINGS: The overarching themes were (1) 'Ritual of hand over' with the categories: (a) 'Ready, able and willing', (b) 'Transfer of responsibility' and (c) 'Nice to know versus need to know' and (2) 'From lifesaving care to rehabilitative care' with the categories: (a) 'Complex care needs persist', (b) 'Fight or flight mode' and (c) '"Weaning" the family'. Nurses were highly focused on the ritual of the actual handover of the patient and discussed readiness as an indicator of quality and the feeling of passing on the responsibility. Nurses had different opinions on what useful knowledge was and thus necessary to communicate during handover. Although patients' complex care needs may not have been resolved when exiting the ICU, ward nurses had to receive patients in a setting where nurses were mostly comfortable within their own specialty - this was worrying for both type of nurses. Patients could enter the ward very exhausted and weak or in 'fight mode' and demand rehabilitation at a pace the ward was not capable of delivering. ICU nurses encouraged families to be demanding after the ICU stay, and ward nurses asked them to trust them and steep back.
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Enfermeras y Enfermeros , Cuidado de Transición , Humanos , Unidades de Cuidados Intensivos , Transferencia de Pacientes , Investigación Cualitativa , Hospitales UniversitariosRESUMEN
BACKGROUND AND PURPOSE OF STUDY: Transition from the intensive care unit to the hospital ward can be considered as a vulnerable period for patients as nursing care changes hands. How the transition is experienced by the ICU patient and the family is influenced by how it is organised, communicated and executed. The transition may positively or negatively affect patient recovery. AIM: To explore the experiences of intensive care unit patients and their relatives during the transition to hospital ward in order to find ways of supporting them during the transition process. METHODS: Eligible participants were asked for participation from April to September 2016 from a mixed medical and surgical intensive care unit (Level II) at a university hospital. We conducted six semi-structured interviews with former intensive care unit patients and four dyad interviews with patients and spouses. Data were analysed according to the methodology Interpretive Description with the aim to discover associations, relationships and patterns within the phenomenon. RESULTS: Our analysis revealed the following three themes: (1) Taking up the mantel (2) Adjusting to 'being one in the crowd' and (3) Integrated spouses became visitors. It was a change from an environment with high dependence to increasing independence and a shift from attention to loneliness. Focus moved from the bodily functions to basic activities of living. Spouses experienced that their position was reduced from integrated relatives in the intensive care unit to visitors of the hospital ward. CONCLUSIONS: This article shows that it is important to mentally prepare patients and their family for transfer and a gradual withdrawal of intense nursing observation and monitoring. Discharge planning should begin early and involve spouses to a higher extent as they have a major role in the recovery process far beyond hospitalisation.