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Respiratory Insufficiency clinical trials

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NCT ID: NCT03221101 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Home Non Invasive Ventilation for COPD Patients

NIVOLD
Start date: December 2011
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. The purpose of this study is to determine whether home non invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure episode treated by non invasive ventilation.

NCT ID: NCT03203577 Completed - Clinical trials for Neuromuscular Diseases

Initiation of Home Mechanical Ventilation at Home in Patients With Chronic Hypercapnic Respiratory Failure

Homerun
Start date: July 2015
Phase: N/A
Study type: Interventional

Objective: To prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. In addition we believe that the start at home is cheaper compared to an in-hospital start. Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost effective compared to a hospital-based initiation. Study design: A nationwide non-inferiority multi-center randomized parallel active control study. Study population: Patients with chronic respiratory insufficiency due to a neuromuscular disease (NMD) or thoracic cage problem who are referred for chronic ventilator support. Intervention: The start of HMV at home Standard intervention to be compared to: The start of HMV is normally in a clinical setting as recommended in the national guideline. Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function; nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome. A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96 patients in total. Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial. Costs of the initiation of HMV at home and in the hospital will be estimated form a societal perspective over a time horizon of 6 months. Time schedule: After an initial phase of 6 months recruitment will start and will take 24 months. Thirty-six months after the start of the study the last assessments will be done and analysis and writing of the papers will start. After 42 months the study will end.

NCT ID: NCT03201263 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Sigh in Acute Hypoxemic Respiratory Failure

PROTECTION
Start date: December 20, 2017
Phase: N/A
Study type: Interventional

Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016). Early implementation of a specific mechanical ventilation mode that enhances lung protection in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a tremendous impact on clinical practice. Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to assisted mechanical ventilation: improves oxygenation without increasing ventilation pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure; improves regional compliances. Thus, physiologic studies generated the hypothesis that addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung strain and stress through various synergic mechanisms potentially yielding decreased risk of VILI, faster weaning and improved clinical outcomes. The investigators conceived a pilot RCT to verify clinical feasibility of the addition of Sigh to PSV in comparison to standard PSV. The investigators will enrol 258 intubated spontaneously breathing patients with mild to moderate AHRF and ARDS admitted to the ICU. Patients will be randomized through an online automatic centralized and computerized system to the following study groups (1:1 ratio): - PSV group: will be treated by protective PSV settings until day 28 or death or performance of spontaneous breathing trial (SBT); - PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh until day 28 or death or performance of spontaneous breathing trial (SBT). Indications on ventilation settings, weaning, spontaneous breathing trial and rescue treatment will be specified.

NCT ID: NCT03194750 Completed - Respiratory Failure Clinical Trials

Ultrasound Assessment of Volume in Patients on Continuous Dialysis

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

Renal failure and resuscitation measures in critically ill patients can result in fluid overload. Fluid overload in renal failure patients can cause harmful effects like pulmonary edema, anasarca and congestive cardiac failure exacerbations among other complications. These have been associated with increased time on the ventilator, increased length of stay in the ICU, and higher overall mortality for patients requiring dialysis in the ICU. The current standard of care for adjusting fluid removal rates in patients on continuous renal replacement therapy relies on clinical judgement. Clinicians take into account factors like the patient's condition, vasopressor requirements, kidney function, total intake and outputs, vital signs, and physical examination findings when making daily changes to fluid removal rates on dialysis machines. Such assessment is highly subjective and can be imprecise/inaccurate leading to hypotension and hemodynamic instability in a critically ill patient. Use of conventional ultrasound by physicians to assess volume status using compressibility of the inferior vena cava has been shown to be a reliable predictor of volume status and can help guide therapy. Such use makes bedside volume assessment a non-invasive, rapid, repeatable point of care tool that can provide objective data to guide fluid removal determine velocity of fluid removal and help identify patients at risk of hypotension and hemodynamic instability during the process of fluid removal. Apart from rare possible local allergic reactions to ultrasound jelly and transient local discomfort, the disadvantages are minimal. Ultrasonography has been considered a safe imaging modality. This protocol will measure inferior vena cava compressibility using the General Electric VScan with Dual Probe, which has FDA approval for abdominal and vascular imaging in humans.

NCT ID: NCT03188770 Completed - Clinical trials for Mechanical Ventilation

Practice of Ventilation in Middle-Income Countries

PRoVENT-iMIC
Start date: November 1, 2017
Phase:
Study type: Observational

The purpose of this international, multicenter service review is to describe and compare ventilation management in patients at risk of acute respiratory distress syndrome (ARDS) versus patients not at risk and patients with established ARDS, and to ascertain whether certain ventilator settings and ventilation parameters are associated with pulmonary complications or development of ARDS after start of ventilation in patients in intensive care units (ICUs) in Asian countries. Participating centers will include adult patients undergoing mechanical ventilation in the ICU during a 28-day period. Patients' data will be collected during the first 7 days in the ICU, or until ICU discharge. Follow up is until ICU discharge. The primary outcome includes two main ventilator settings, i.e., tidal volume and the level of positive end-expiratory pressure. Secondary endpoints are development of ARDS in patients without ARDS at the onset of mechanical ventilation, worsening of ARDS in patients with ARDS at the onset of mechanical ventilation, pulmonary infection, other pulmonary complications, need for tracheostomy, duration of ventilation, length of ICU stay and ICU mortality.

NCT ID: NCT03180385 Terminated - Respiratory Failure Clinical Trials

NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery

NAVA
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to providing respiratory support post-operatively. The investigators hypothesize that providing synchronized biphasic support with NAVA will be associated with shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive either NAVA or BiPAP following their cardiothoracic surgery.

NCT ID: NCT03178565 Recruiting - Respiratory Failure Clinical Trials

The Effects of Mechanical Insufflation-exsufflation on Airway Mucus Clearance in the ICU

Start date: December 2016
Phase: N/A
Study type: Interventional

The present study aims to evaluate the effect of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU patients. A parallel group randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical ventilation >24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1 ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or standard respiratory physiotherapy without the use of the mechanical insufflation-exsufflation device (control group). The primary outcome is the amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of respiratory physiotherapy.

NCT ID: NCT03174002 Completed - Clinical trials for Hypoxemic Respiratory Failure

Handling Oxygenation Targets in the Intensive Care Unit

HOT-ICU
Start date: June 19, 2017
Phase: Phase 4
Study type: Interventional

Handling oxygenation targets (HOT) is standard of care in the intensive care unit (ICU), however the quality and quantity of evidence is low and potential harm has been reported. The aim of the HOT-ICU trial is to assess the overall benefits and harms of two levels of oxygenation targets in adult critically ill patients with acute hypoxaemic respiratory failure in the ICU.

NCT ID: NCT03171935 Recruiting - Clinical trials for Patients With Acute Hypoxemic Respiratory Failure

Wean Early With HFNCO vs NPPV in Patients With AHRF

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The main purpose of the present study is to verify whether, as compared with conventional weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive pressure ventilation may more effective in shortening the duration of invasive ventilation, hence reducing the rates of complications and mortality in patients with acute hypoxemic respiratory failure.

NCT ID: NCT03166826 Completed - Clinical trials for Neonatal Respiratory Failure

Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room

Start date: May 1, 2017
Phase:
Study type: Observational

Apgar scoring system has been widely used for the evaluation of the infant's postnatal condition. As conventional Apgar scoring system is affected by gestational age and resuscitative efforts, there is a need for development of new scoring systems for the assessment in the delivery room. Herein, Modified Combined Apgar scoring system which includes two new parameters (cord blood pH and targeted oxygen saturation level) has been developed and the utility of this modified system was compared with Conventional and Combined Apgar scoring systems for prediction of hospitalization.