Digital Action Plan (Web App) for Managing Asthma Exacerbations: Randomized Controlled Trial.

BACKGROUND: A written action plan (WAP) for managing asthma exacerbations is recommended. OBJECTIVE: We aimed to compare the effect on unscheduled medical contacts (UMCs) of a digital action plan (DAP) accessed via a smartphone web app combined with a WAP on paper versus that of the same WAP alone. METHODS: This randomized, unblinded, multicenter (offline recruitment in private offices and public hospitals), and parallel-group trial included children (aged 6-12 years) or adults (aged 18-60 years) with asthma who had experienced at least 1 severe exacerbation in the previous year. They were randomized to a WAP or DAP+WAP group in a 1:1 ratio. The DAP (fully automated) provided treatment advice according to the severity and previous pharmacotherapy of the exacerbation. The DAP was an algorithm that recorded 3 to 9 clinical descriptors. In the app, the participant first assessed the severity of their current symptoms on a 10-point scale and then entered the symptom descriptors. Before the trial, the wordings and ordering of these descriptors were validated by 50 parents of children with asthma and 50 adults with asthma; the app was not modified during the trial. Participants were interviewed at 3, 6, 9, and 12 months to record exacerbations, UMCs, and WAP and DAP use, including the subjective evaluation (availability and usefulness) of the action plans, by a research nurse. RESULTS: Overall, 280 participants were randomized, of whom 33 (11.8%) were excluded because of the absence of follow-up data after randomization, leaving 247 (88.2%) participants (children: n=93, 37.7%; adults: n=154, 62.3%). The WAP group had 49.8% (123/247) of participants (children: n=45, 36.6%; mean age 8.3, SD 2.0 years; adults: n=78, 63.4%; mean age 36.3, SD 12.7 years), and the DAP+WAP group had 50.2% (124/247) of participants (children: n=48, 38.7%; mean age 9.0, SD 1.9 years; adults: n=76, 61.3%; mean age 34.5, SD 11.3 years). Overall, the annual severe exacerbation rate was 0.53 and not different between the 2 groups of participants. The mean number of UMCs per year was 0.31 (SD 0.62) in the WAP group and 0.37 (SD 0.82) in the DAP+WAP group (mean difference 0.06, 95% CI -0.12 to 0.24; P=.82). Use per patient with at least 1 moderate or severe exacerbation was higher for the WAP (33/65, 51% vs 15/63, 24% for the DAP; P=.002). Thus, participants were more likely to use the WAP than the DAP despite the nonsignificant difference between the action plans in the subjective evaluation. Median symptom severity of the self-evaluated exacerbation was 4 out of 10 and not significantly different from the symptom severity assessed by the app. CONCLUSIONS: The DAP was used less often than the WAP and did not decrease the number of UMCs compared with the WAP alone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02869958; https://clinicaltrials.gov/ct2/show/NCT02869958.

Antiplatelet Drugs and Risk of Bleeding After Bedside Pleural Procedures: A National Multicenter Cohort Study.

BACKGROUND: The decision-making on antiplatelet drug withdrawal or continuation before performing a pleural procedure is based on the balance between the risk of bleeding associated with the antiplatelet therapy and the risk of arterial thrombosis due to its interruption. Knowledge on antiplatelet therapy-associated risk of bleeding after pleural procedures is lacking. RESEARCH QUESTION: Is the risk of bleeding associated with antiplatelet drugs increased in patients undergoing pleural procedures? STUDY DESIGN AND METHODS: We conducted a French multicenter cohort study in 19 centers. The main outcome was the occurrence of bleeding, defined as hematoma, hemoptysis, or hemothorax, during the 24 h following a pleural procedure. Serious bleeding events were defined as bleeding requiring blood transfusion, respiratory support, endotracheal intubation, embolization, or surgery, or as death. RESULTS: A total of 1,124 patients was included (men, 66%; median age, 62.6 ± 27.7 years), of whom 182 were receiving antiplatelet therapy and 942 were not. Fifteen patients experienced a bleeding event, including eight serious bleeding events. The 24-h incidence of bleeding was 3.23% (95% CI, 1.08%-5.91%) in the antiplatelet group and 0.96% (95% CI, 0.43%-1.60%) in the control group. The occurrence of bleeding events was significantly associated with antiplatelet therapy in univariate analysis (OR, 3.44; 95% CI, 1.14-9.66; P = .021) and multivariate analysis (OR, 4.13; 95% CI, 1.01-17.03; P = .044) after adjusting for demographic data and the main risk factors for bleeding. Likewise, antiplatelet therapy was significantly associated with serious bleeding in univariate analysis (OR, 8.61; 95% CI, 2.09-42.3; P = .003) and multivariate analysis (OR, 7.27; 95% CI, 1.18-56.1; P = .032) after adjusting for the number of risk factors for bleeding. INTERPRETATION: Antiplatelet therapy was associated with an increased risk of post-pleural procedure bleeding and serious bleeding. Future guidelines should take into account these results for patient safety.

Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial.

RATIONALE: Ventilator-associated pneumonia (VAP) causes substantial morbidity and mortality. The influence of subglottic secretion drainage (SSD) in preventing VAP remains controversial. OBJECTIVES: To determine whether SSD reduces the overall incidence of microbiologically confirmed VAP. METHODS: Randomized controlled clinical trial conducted at four French centers. A total of 333 adult patients intubated with a tracheal tube allowing drainage of subglottic secretions and expected to require mechanical ventilation for ≥48 hours was included. Patients were randomly assigned to undergo intermittent SSD (n = 169) or not (n = 164). MEASUREMENTS AND MAIN RESULTS: Primary outcome was the overall incidence of VAP based on quantitative culture of distal pulmonary samplings performed after each clinical suspicion. Other outcomes included incidence of early- and late-onset VAP, duration of mechanical ventilation, and hospital mortality. Microbiologically confirmed VAP occurred in 67 patients, 25 of 169 (14.8%) in the SSD group and 42 of 164 (25.6%) in the control group (P = 0.02), yielding a relative risk reduction of 42.2% (95% confidential interval, 10.4-63.1%). Using the Day 5 threshold, the beneficial effect of SSD in reducing VAP was observed in both early-onset VAP (2 of 169 [1.2%] patients undergoing SSD vs. 10 of 164 [6.1%] control patients; P = 0.02) and late-onset VAP (23 of 126 [18.6%] patients undergoing SSD vs. 32 of 97 [33.0%] control patients; P = 0.01). VAP was clinically suspected at least once in 51 of 169 (30.2%) patients undergoing SSD and 60 of 164 (36.6%) control patients (P = 0.25). No significant between-group differences were observed in duration of mechanical ventilation and hospital mortality. CONCLUSIONS: Subglottic secretion drainage during mechanical ventilation results in a significant reduction in VAP, including late-onset VAP. Clinical trial registered with www.clinicaltrials.gov (NCT00219661).

Frequency and clinical impact of preserved bispectral index activity during deep sedation in mechanically ventilated ICU patients.

OBJECTIVE: Despite an overall correlation between the bispectral index of the EEG (BIS) and clinical sedation assessment, unexpectedly high BIS values can be observed at deep sedation levels. We assessed the frequency, interindividual variability and clinical impact of high BIS values during clinically deep sedation. DESIGN AND SETTING: Prospective observational study in two university-affiliated intensive care units. PATIENTS: Sixty-two mechanically ventilated patients requiring intravenous sedation and analgesia for >or=24 h. MEASUREMENTS AND MAIN RESULTS: Paired measurements of BIS and sedation measured on the adaptation to intensive care environment (ATICE) score were obtained every 3 h until awakening. A paired measurement with BIS >60 at deep sedation (ATICE Awakeness

Recurrent takotsubo cardiomyopathy triggered by convulsive status epilepticus.

INTRODUCTION: Takotsubo cardiomyopathy can complicate several conditions including neurological emergencies. A few recurrent cases associated with seizures have been reported, but none of the patients had status epilepticus. The pathophysiology of takotsubo syndrome, although debated, may involve stunning of the myocardium by a catecholamine storm triggered by stress. Patients with epilepsy may be at increased risk for takotsubo syndrome, which may occur repeatedly. METHODS: We report on a postmenopausal woman with symptomatic epilepsy who experienced recurrent takotsubo cardiomyopathy triggered by convulsive status epilepticus. Brief seizures were not associated with takotsubo syndrome. The relevant literature was reviewed. RESULTS: Over a 1-year period, she experienced two episodes of convulsive status epilepticus with complete neurological recovery after treatment. Echocardiography showed latero-septo-apical hypokinesia and apical ballooning. The cardiac abnormalities resolved fully and she recovered her baseline level of self-sufficiency. During the same period, she experienced several brief seizures, with no cardiac manifestations. CONCLUSION: The occurrence of takotsubo cardiomyopathy in association with convulsive status epilepticus, but not with brief seizures, supports neurogenically mediated myocardial stunning related to direct toxicity of endogenous catecholamines. Neuro-intensivists must be aware of this potentially fatal but fully reversible cardiac complication, which may be among the causes of death in patients with status epilepticus.

Sedation algorithm in critically ill patients without acute brain injury.

OBJECTIVE: To determine whether use of a sedation algorithm to promote a high level of tolerance to the intensive care environment and preserve consciousness affected time to arousal and duration of mechanical ventilation in patients without acute brain injury. DESIGN: Two-phase, prospective, controlled study. SETTING: University-affiliated medical intensive care unit. PATIENTS: : Patients without acute brain injury requiring mechanical ventilation for at least 24 hrs. INTERVENTIONS: During the control phase, sedatives and analgesics were adjusted according to the physician's decision. During the algorithm phase, sedatives and analgesics were adjusted according to an algorithm developed by a multidisciplinary team including nurses and physicians. The algorithm was based on regular assessments of consciousness and tolerance to the intensive care unit environment using the Adaptation to Intensive Care Environment instrument and was designed to achieve tolerance and maintain a high level of consciousness. Standard practices, including weaning from the ventilator, were the same during both study phases. MEASUREMENTS AND MAIN RESULTS: A total of 102 patients were enrolled (control group, n = 54; algorithm group, n = 48). Median duration of mechanical ventilation was significantly shorter in the algorithm group (4.4 days [interquartile range, 2.1-9.8]) compared with the control group (10.3 days [3.5-17.2], p = .014), representing a 57.3% reduction. In Cox multivariate analysis, the risk of remaining on mechanical ventilation was 0.48 times (95% confidence interval, 0.29-0.78) lower for algorithm patients compared with controls. The median time to arousal was also significantly shorter in patients in the algorithm group (2 days [2-5]) compared with the control group (4 days [2-9], p = .006). CONCLUSIONS: The use of a sedation algorithm to promote tolerance to the intensive care environment and preserve consciousness in patients without acute brain injury resulted in a marked decrease in the duration of mechanical ventilation. This reduction was at least partly attributable to a shorter time to arousal after initiation of mechanical ventilation.

Adaptation to the Intensive Care Environment (ATICE): development and validation of a new sedation assessment instrument.

OBJECTIVE: To develop a valid, reliable, and responsive bedside instrument assessing Adaptation to the Intensive Care Environment (ATICE) in mechanically ventilated adult intensive care unit (ICU) patients. DESIGN: Instrument development and prospective clinimetric evaluation. SETTING: University-affiliated medical ICU. PATIENTS: Consecutive patients with expected mechanical ventilation of >/=12 hrs. INTERVENTIONS: Administration of ATICE. MEASUREMENTS AND MAIN RESULTS: Item generation for the ATICE involved focus groups and literature review. The ATICE consists of five items: Awakeness and Comprehension combined in a Consciousness domain, and Calmness, Ventilator Synchrony, and Face Relaxation combined in a Tolerance domain. Clinical sensibility of the ATICE assessed by ten ICU physicians and 20 ICU nurses not involved in the development of the ATICE was rated highly (median values 5-7 on a 7-point scale). The ATICE was administered to 80 patients during a total of 152 assessments. Each assessment was performed by three raters (ICU physician, ICU nurse, research nurse), concomitantly with independent scoring of four scales (Ramsay Scale, Riker Scale, Glasgow Coma Scale, and Comfort Scale) and six visual analog scales. Internal consistency was high, as reflected by Cronbach's alpha for the Consciousness and Tolerance domains of .87 and .67, respectively. Intraclass correlation coefficients for the Consciousness and the Tolerance domains ranged from .92 to .99, indicating high interrater reliability. Cross-sectional and longitudinal validity was confirmed for the overall ATICE and the Consciousness and Tolerance domains, as reflected by strong correlations between ATICE and the relevant items or domains of the Ramsay Scale, Riker Scale, Glasgow Coma Scale, Comfort Scale, each of the visual analog scales, and the amounts of sedatives and analgesics administered. CONCLUSIONS: The ATICE measures the adaptation of mechanically ventilated patients to the ICU environment. After rigorous multidisciplinary development, we demonstrated high reliability, validity, and responsiveness of this instrument.