Helmet continuous positive airway pressure (CPAP) and arm deep vein thrombosis (DVT) in COVID-19: a double-edged sword.
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ABSTRACT:
SUBMITTER: Lucci C
PROVIDER: S-EPMC8107520 | biostudies-literature | 2021 Apr
REPOSITORIES: biostudies-literature
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Helmet continuous positive airway pressure (CPAP) and arm deep vein thrombosis (DVT) in COVID-19: a double-edged sword.
Lucci Carla C Manca Thiesi Elena E Pappalardo Federico F
Journal of thoracic disease 20210401 4
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Project description:The risk of venous thromboembolism (VTE) is higher after the total hip or knee replacement surgery than after almost any other surgical procedure; warfarin sodium is commonly prescribed to reduce this peri-operative risk. Warfarin has a narrow therapeutic window with high inter-individual dose variability and can cause hemorrhage. The genetics-informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT) is a 2 × 2 factorial-design, randomized controlled trial designed to compare the safety and effectiveness of warfarin-dosing strategies. GIFT will answer two questions: (1) does pharmacogenetic (PGx) dosing reduce the rate of adverse events in orthopedic patients; and (2) is a lower target international normalized ratio (INR) non-inferior to a higher target INR in orthopedic participants? The composite primary endpoint of the trial is symptomatic and asymptomatic VTE (identified on screening ultrasonography), major hemorrhage, INR ? 4, and death.
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Project description:BackgroundUpper extremity deep vein thrombosis (UEDVT) constitutes approximately 10% of all deep vein thromboses (DVTs). The incidence of UEDVT is increasing in association with use of peripherally inserted central venous catheters. Treatment for UEDVT is derived largely from evidence for treatment of lower extremity DVT. Limited evidence exists for the use of a direct oral anticoagulant for the treatment of UEDVT.PopulationSequential patients identified within the Intermountain Healthcare System and University of Utah Healthcare system with symptomatic UEDVT defined as the formation of thrombus within the internal jugular, subclavian, axillary, brachial, ulnar, or radial veins of the arm.InterventionApixaban 10 mg PO twice daily for 7 days followed by apixaban 5 mg twice daily for 11 weeks.ComparisonThe historical literature review rate of venous thrombosis reported for recurrent clinically overt objective venous thromboembolism (VTE) and VTE-related death. If the confidence interval for the observed rate excludes the threshold event rate of 4%, we will conclude that treatment with apixaban is noninferior and therefore a clinically valid approach to treat UEDVT.Sample sizeWe elected a sample size of 375 patients so that an exact 95% confidence interval would exclude an event rate of VTE in the observation cohort of 4%.OutcomeNinety-day rate of new or recurrent objectively confirmed symptomatic venous thrombosis and VTE-related death. The primary safety outcome is the composite of major and clinically relevant nonmajor bleeding.
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Project description:BackgroundPatients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking.MethodsWe plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021.DiscussionWe hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic.Trial registrationClinicalTrials.gov NCT04395807 . Registered on 20 May 2020.
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Project description:ObjectiveTo test the hypothesis that infants born <30 weeks' gestation supported by Seattle-PAP will have lower rates of continuous positive airway pressure (CPAP) failure than infants supported with conventional, Fisher&Paykel-CPAP (FP-CPAP).Study designRandomized trial (3/2017-01/2019) at 5 NICUs. The primary outcome was CPAP failure; subgroup analyses (gestational age, receipt antenatal corticosteroids) were performed.ResultsA total of 232 infants were randomized. Infants in the Seattle-PAP and FP-CPAP groups had mean gestational ages of 27.0 and 27.2 weeks, respectively. We observed no differences in rates of treatment failure between Seattle-PAP (40/112, 35.7%) and FP-CPAP (38/120, 31.7%; risk difference, 4.1%; 95% CI, -8.1-16.2; P = 0.51). Subgroup analysis indicated no differences in rates of CPAP failure. We observed no differences between the two groups in frequencies of adverse events or duration of respiratory support.ConclusionsAmong infants born <30 weeks' gestation, rates of CPAP failure did not differ between Seattle-PAP and FP-CPAP.
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Project description:Context and objectiveNoninvasive mechanical ventilation during the postoperative period (PO) following lung resection can restore residual functional capacity, improve oxygenation and spare the inspiratory muscles. The objective of this study was to assess the efficacy of continuous positive airway pressure (CPAP) associated with physiotherapy, compared with physiotherapy alone after lung resection.Design and settingOpen randomized clinical trial conducted in the clinical hospital of Universidade Estadual de Campinas.MethodSessions were held in the immediate postoperative period (POi) and on the first and second postoperative days (PO1 and PO2), and the patients were reassessed on the discharge day. CPAP was applied for two hours and the pressure adjustment was set between 7 and 8.5 cmH2O. The oxygenation index (OI), Borg scale, pain scale and presence of thoracic drains and air losses were evaluated.ResultsThere was a significant increase in the OI in the CPAP group in the POi compared to the Chest Physiotherapy (CP) group, P = 0.024. In the CP group the OI was significantly lower on PO1 (P = 0,042), than CPAP group. The air losses were significantly greater in the CPAP group in the POi and on PO1 (P = 0.001, P = 0.028), but there was no significant difference between the groups on PO2 and PO3. There was a statistically significant difference between the groups regarding the Borg scale in the POi (P < 0.001), but there were no statistically significant differences between the groups regarding the pain score.ConclusionCPAP after lung resection is safe and improves oxygenation, without increasing the air losses through the drains.Clinical trial registrationNCT01285648.
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