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"Respiration, Artificial - methods"
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Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece
by
Reignier, Jean
,
Dres, Martin
,
Sedillot, Nicholas
in
Airway Extubation - adverse effects
,
Airway Extubation - methods
,
Anesthesia
2022
Among patients with a high risk of reintubation, spontaneous-breathing trials performed with pressure-support ventilation did not result in significantly more ventilator-free days at day 28 than T-piece trials.
Journal Article
Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial
by
Lagier, David
,
Vidal Melo, Marcos F
,
Lalande, Marion
in
Body weight
,
Bypass
,
Evidence-based medicine
2019
PurposeTo evaluate whether a perioperative open-lung ventilation strategy prevents postoperative pulmonary complications after elective on-pump cardiac surgery.MethodsIn a pragmatic, randomized, multicenter, controlled trial, we assigned patients planned for on-pump cardiac surgery to either a conventional ventilation strategy with no ventilation during cardiopulmonary bypass (CPB) and lower perioperative positive end-expiratory pressure (PEEP) levels (2 cm H2O) or an open-lung ventilation strategy that included maintaining ventilation during CPB along with perioperative recruitment maneuvers and higher PEEP levels (8 cm H2O). All study patients were ventilated with low-tidal volumes before and after CPB (6 to 8 ml/kg of predicted body weight). The primary end point was a composite of pulmonary complications occurring within the first 7 postoperative days.ResultsAmong 493 randomized patients, 488 completed the study (mean age, 65.7 years; 360 (73.7%) men; 230 (47.1%) underwent isolated valve surgery). Postoperative pulmonary complications occurred in 133 of 243 patients (54.7%) assigned to open-lung ventilation and in 145 of 245 patients (59.2%) assigned to conventional ventilation (p = 0.32). Open-lung ventilation did not significantly reduce the use of high-flow nasal oxygenotherapy (8.6% vs 9.4%; p = 0.77), non-invasive ventilation (13.2% vs 15.5%; p = 0.46) or new invasive mechanical ventilation (0.8% vs 2.4%, p = 0.28). Mean alive ICU-free days at postoperative day 7 was 4.4 ± 1.3 days in the open-lung group vs 4.3 ± 1.3 days in the conventional group (mean difference, 0.1 ± 0.1 day, p = 0.51). Extra-pulmonary complications and adverse events did not significantly differ between groups.ConclusionsA perioperative open-lung ventilation including ventilation during CPB does not reduce the incidence of postoperative pulmonary complications as compared with usual care. This finding does not support the use of such a strategy in patients undergoing on-pump cardiac surgery.Trial registrationClinicaltrials.gov Identifier: NCT 02866578. https://clinicaltrials.gov/ct2/show/NCT02866578
Journal Article
Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome
by
Constantin, Jean-Michel
,
Quenot, Jean-Pierre
,
Louis, Guillaume
in
Adult
,
Aged
,
Blood pressure
2020
Patients with acute respiratory distress syndrome received conservative oxygen therapy or liberal oxygen therapy for 7 days. The trial was prematurely stopped because of futility and safety concerns. Mortality at day 28 was 34.3% in the conservative-oxygen group and 26.5% in the liberal-oxygen group. Five mesenteric ischemic events occurred, all in the conservative-oxygen group.
Journal Article
Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation
2022
Invasive mechanical ventilation in critically ill adults involves adjusting the fraction of inspired oxygen to maintain arterial oxygen saturation. The oxygen-saturation target that will optimize clinical outcomes in this patient population remains unknown.
In a pragmatic, cluster-randomized, cluster-crossover trial conducted in the emergency department and medical intensive care unit at an academic center, we assigned adults who were receiving mechanical ventilation to a lower target for oxygen saturation as measured by pulse oximetry (Spo
) (90%; goal range, 88 to 92%), an intermediate target (94%; goal range, 92 to 96%), or a higher target (98%; goal range, 96 to 100%). The primary outcome was the number of days alive and free of mechanical ventilation (ventilator-free days) through day 28. The secondary outcome was death by day 28, with data censored at hospital discharge.
A total of 2541 patients were included in the primary analysis. The median number of ventilator-free days was 20 (interquartile range, 0 to 25) in the lower-target group, 21 (interquartile range, 0 to 25) in the intermediate-target group, and 21 (interquartile range, 0 to 26) in the higher-target group (P = 0.81). In-hospital death by day 28 occurred in 281 of the 808 patients (34.8%) in the lower-target group, 292 of the 859 patients (34.0%) in the intermediate-target group, and 290 of the 874 patients (33.2%) in the higher-target group. The incidences of cardiac arrest, arrhythmia, myocardial infarction, stroke, and pneumothorax were similar in the three groups.
Among critically ill adults receiving invasive mechanical ventilation, the number of ventilator-free days did not differ among groups in which a lower, intermediate, or higher Spo
target was used. (Supported by the National Heart, Lung, and Blood Institute and others; PILOT ClinicalTrials.gov number, NCT03537937.).
Journal Article
Acute Outcomes and 1-Year Mortality of Intensive Care Unit–acquired Weakness. A Cohort Study and Propensity-matched Analysis
by
Vanhullebusch, Tine
,
Clerckx, Beatrix
,
Van Cromphaut, Sophie
in
Aged
,
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
,
Biological and medical sciences
2014
Intensive care unit (ICU)-acquired weakness is a frequent complication of critical illness. It is unclear whether it is a marker or mediator of poor outcomes.
To determine acute outcomes, 1-year mortality, and costs of ICU-acquired weakness among long-stay (≥8 d) ICU patients and to assess the impact of recovery of weakness at ICU discharge.
Data were prospectively collected during a randomized controlled trial. Impact of weakness on outcomes and costs was analyzed with a one-to-one propensity-score-matching for baseline characteristics, illness severity, and risk factor exposure before assessment. Among weak patients, impact of persistent weakness at ICU discharge on risk of death after 1 year was examined with multivariable Cox proportional hazards analysis.
A total of 78.6% were admitted to the surgical ICU; 227 of 415 (55%) long-stay assessable ICU patients were weak; 122 weak patients were matched to 122 not-weak patients. As compared with matched not-weak patients, weak patients had a lower likelihood for live weaning from mechanical ventilation (hazard ratio [HR], 0.709 [0.549-0.888]; P = 0.009), live ICU (HR, 0.698 [0.553-0.861]; P = 0.008) and hospital discharge (HR, 0.680 [0.514-0.871]; P = 0.007). In-hospital costs per patient (+30.5%, +5,443 Euro per patient; P = 0.04) and 1-year mortality (30.6% vs. 17.2%; P = 0.015) were also higher. The 105 of 227 (46%) weak patients not matchable to not-weak patients had even worse prognosis and higher costs. The 1-year risk of death was further increased if weakness persisted and was more severe as compared with recovery of weakness at ICU discharge (P < 0.001).
After careful matching the data suggest that ICU-acquired weakness worsens acute morbidity and increases healthcare-related costs and 1-year mortality. Persistence and severity of weakness at ICU discharge further increased 1-year mortality. Clinical trial registered with www.clinicaltrials.gov (NCT 00512122).
Journal Article
Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure
by
Lange, Theis
,
Andersen, Cheme
,
Bäcklund, Minna
in
Aged
,
Blood pressure
,
Chronic obstructive pulmonary disease
2021
Even though supplemental oxygen is used for the treatment of patients with hypoxemic respiratory failure, the most effective oxygenation targets are not known. In this randomized trial, a lower oxygenation target did not result in lower mortality than a higher target.
Journal Article
Conservative versus Liberal Oxygenation Targets for Mechanically Ventilated Patients. A Pilot Multicenter Randomized Controlled Trial
2016
There are no randomized controlled trials comparing different oxygenation targets for intensive care unit (ICU) patients.
To determine whether a conservative oxygenation strategy is a feasible alternative to a liberal oxygenation strategy among ICU patients requiring invasive mechanical ventilation (IMV).
At four multidisciplinary ICUs, 103 adult patients deemed likely to require IMV for greater than or equal to 24 hours were randomly allocated to either a conservative oxygenation strategy with target oxygen saturation as measured by pulse oximetry (SpO2) of 88-92% (n = 52) or a liberal oxygenation strategy with target SpO2 of greater than or equal to 96% (n = 51).
The mean area under the curve and 95% confidence interval (CI) for SpO2 (93.4% [92.9-93.9%] vs. 97% [96.5-97.5%]), SaO2 (93.5% [93.1-94%] vs. 96.8% [96.3-97.3%]), PaO2 (70 [68-73] mm Hg vs. 92 [89-96] mm Hg), and FiO2 (0.26 [0.25-0.28] vs. 0.36 [0.34-0.39) in the conservative versus liberal oxygenation arm were significantly different (P < 0.0001 for all). There were no significant between-group differences in any measures of new organ dysfunction, or ICU or 90-day mortality. The percentage time spent with SpO2 less than 88% in conservative versus liberal arm was 1% versus 0.3% (P = 0.03), and percentage time spent with SpO2 greater than 98% in conservative versus liberal arm was 4% versus 22% (P < 0.001). The adjusted hazard ratio for 90-day mortality in the conservative arm was 0.77 (95% CI, 0.40-1.50; P = 0.44) overall and 0.49 (95% CI, 0.20-1.17; P = 0.10) in the prespecified subgroup of patients with a baseline PaO2/FiO2 less than 300.
Our study supports the feasibility of a conservative oxygenation strategy in patients receiving IMV. Larger randomized controlled trials of this intervention appear justified. Clinical trial registered with Australian New Zealand Clinical Trials Registry (ACTRN 12613000505707).
Journal Article
Conservative oxygen therapy for mechanically ventilated adults with sepsis: a post hoc analysis of data from the intensive care unit randomized trial comparing two approaches to oxygen therapy (ICU-ROX)
by
McArthur, Colin
,
Mackle, Diane
,
Bellomo Rinaldo
in
Clinical trials
,
Estimates
,
Health services
2020
PurposeSepsis is a common reason for intensive care unit (ICU) admission and mortality in ICU patients. Despite increasing interest in treatment strategies limiting oxygen exposure in ICU patients, no trials have compared conservative vs. usual oxygen in patients with sepsis.MethodsWe undertook a post hoc analysis of the 251 patients with sepsis enrolled in a trial that compared conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary end point for the current analysis was 90-day mortality. Key secondary outcomes were cause-specific mortality, ICU and hospital length of stay, ventilator-free days, vasopressor-free days, and the proportion of patients receiving renal replacement therapy in the ICU.ResultsPatients with sepsis allocated to conservative oxygen therapy spent less time in the ICU with an SpO2 ≥ 97% (23.5 h [interquartile range (IQR) 8–70] vs. 47 h [IQR 11–93], absolute difference, 23 h; 95% CI 8–38), and more time receiving an FiO2 of 0.21 than patients allocated to usual oxygen therapy (20.5 h [IQR 1–79] vs. 0 h [IQR 0–10], absolute difference, 20 h; 95% CI 14–26). At 90-days, 47 of 130 patients (36.2%) assigned to conservative oxygen and 35 of 120 patients (29.2%) assigned to usual oxygen had died (absolute difference, 7 percentage points; 95% CI − 4.6 to 18.6% points; P = 0.24; interaction P = 0.35 for sepsis vs. non-sepsis). There were no statistically significant differences between groups for secondary outcomes but point estimates of treatment effects consistently favored usual oxygen therapy.ConclusionsPoint estimates for the treatment effect of conservative oxygen therapy on 90-day mortality raise the possibility of clinically important harm with this intervention in patients with sepsis; however, our post hoc analysis was not powered to detect the effects suggested and our data do not exclude clinically important benefit or harm from conservative oxygen therapy in this patient group.Clinical Trials RegistryICU-ROX Australian and New Zealand Clinical Trials Registry number ACTRN12615000957594.
Journal Article
Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia
by
Chen, Chung M.
,
Hsieh, Wu S.
,
Lin, Hung C.
in
Bronchopulmonary Dysplasia - prevention & control
,
Budesonide - administration & dosage
,
Budesonide - therapeutic use
2016
Bronchopulmonary dysplasia (BPD) is an important complication of mechanical ventilation in preterm infants, and no definite therapy can eliminate this complication. Pulmonary inflammation plays a crucial role in its pathogenesis, and glucocorticoid is one potential therapy to prevent BPD.
To compare the effect of intratracheal administration of surfactant/budesonide with that of surfactant alone on the incidence of death or BPD.
A clinical trial was conducted in three tertiary neonatal centers in the United States and Taiwan, in which 265 very-low-birth-weight infants with severe respiratory distress syndrome who required mechanical ventilation and inspired oxygen (fraction of inspired oxygen, ≥50%) within 4 hours of birth were randomly assigned to one of two groups (131 intervention and 134 control). The intervention infants received surfactant (100 mg/kg) and budesonide (0.25 mg/kg), and the control infants received surfactant only (100 mg/kg), until each infant required inspired O2 at less than 30% or was extubated.
The intervention group had a significantly lower incidence of BPD or death (55 of 131 [42.0%] vs. 89 of 134 [66%]; risk ratio, 0.58; 95% confidence interval, 0.44-0.77; P < 0.001; number needed to treat, 4.1; 95% confidence interval, 2.8-7.8). The intervention group required significantly fewer doses of surfactant than did the control group. The intervention group had significantly lower interleukin levels (IL-1, IL-6, IL-8) in tracheal aspirates at 12 hours and lower IL-8 at 3-5 and 7-8 days.
In very-low-birth-weight infants with severe respiratory distress syndrome, intratracheal administration of surfactant/budesonide compared with surfactant alone significantly decreased the incidence of BPD or death without immediate adverse effect. Clinical trial registered with www.clinicaltrials.gov (NCT-00883532).
Journal Article
Spontaneous breathing trials should be adapted for each patient according to the critical illness. A new individualised approach: the GLOBAL WEAN study
2024
PurposeSpontaneous breathing trials (SBT) evaluate the patient's capacity to maintain inspiratory effort after extubation. SBT practices are heterogeneous and not individualised. The objective of this study was to assess which SBT best reproduces inspiratory effort after extubation in five critical illnesses.MethodsIn this multicentre randomized cross-over study, adult intensive care unit patients under invasive mechanical ventilation for at least 24-h and ready for extubation, underwent three 15-min SBTs in random order: pressure support ventilation level of 7-cmH2O with positive end-expiratory pressure (PEEP) level of 0-cmH2O (PSV7PEEP0), PSV 0-cmH2O with PEEP 0-cmH2O (PSV0PEEP0) and T-piece trial. Primary outcome was the variation of pressure–time-product per minute (PTPmin) between each SBT and 20-min after extubation. Five categories of critical illnesses were selected: abdominal surgery, brain injury, chest trauma, chronic obstructive pulmonary disease (COPD) and miscellaneous.ResultsFive hundred measures of effort from 100 patients were analysed. PTPmin (cmH2O s/min, median and interquartile range, IQR) was 256 (208–321) after extubation, 192 (127–281) at the end of PSV7PEEP0 (p < 0.001 in comparison to after extubation), 291 (235–347) at the end of PSV0PEEP0 and 262 (198–338) at the end of T-piece (both no different from after extubation). One method of SBT in patients with brain injury (PSV0PEEP0), two in abdominal surgery (PSV0PEEP0 and T-piece) and miscellaneous patients (PSV7PEEP0 and T-piece) and all three methods in chest trauma and COPD exacerbation patients replicated reasonably accurately the postextubation effort to breathe.ConclusionUnassisted SBTs, namely PSV0PEEP0 and T-piece trial, are the most appropriate to replicate the postextubation effort to breathe.
Journal Article