Active clinical trials for "Respiratory Insufficiency"

This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).

Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique. Thus, the aim of this study was to compare six modes of VHI, concerning physiological markers of efficacy and safety criteria, in order to support the optimal VHI settings selection for mechanically ventilated patients. In a randomized, controlled and crossover study, 30 mechanically ventilated patients underwent 6 modes of ventilator hyperinflation. The maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), overdistension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.

Patients with chronic respiratory failure such as those associated with Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea (OSA) or Neuromuscular Disease (NMD) are increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV). The aim of this study is to now compare the Automatic Expiratory Positive Airway Pressure (AutoEPAP) algorithm with a fixed manual EPAP in iVAPS mode on an Astral mixed mode ventilator. It is proposed that the automatic settings of AutoEPAP will be as effective at managing respiratory failure and upper airway obstruction (UAO) as manual EPAP on the Astral device. Specifically demonstrating that the AutoEPAP function is as effective at treating UAO as manual EPAP.

Obesity, due to excess fat in the thoracoabdominal region, can promote changes in respiratory function and lung function, leading to reduction in lung volume and capacity. Such dysfunctions are worsen after bariatric surgery to be associated with factors inherent to this procedure. The objective of this study was to evaluate and compare the effects of the application of bilevel positive airway pressure and exercises with inspiratory pressure with linear load in thoracoabdominal mobility, pulmonary function, inspiratory muscle strength, respiratory muscle strength and prevalence of pulmonary complications after bariatric surgery.

Patients undergoing extracorporeal membrane oxygenation (ECMO) are at high risk for deconditioning and functional decline. The primary aim of this study is to assess the functional impact of leg exercise during the pre-ambulation phase in patients undergoing ECMO.

In this study the investigators will assess (i) the effect of partial neuromuscular blockade (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers. Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.

Background. Non invasive positive pressure ventilation (NIV) is among first line treatments of acute respiratory failure. Several interfaces are available for non-invasive ventilation.Despite full face and oronasal masks are more frequently used, some evidence suggests that helmets may optimize patients' comfort and NIV tolerability. During NIV, humidification strategies (heat and moisture exchangers HME or heated humidifiers HH) may significantly affect patient's comfort and work of breathing. Despite physiological data suggested heated humidification as the best strategy during NIV with full face masks, no differences were found in a randomized controlled study assessing the effects of HME or HH on a pragmatic clinical outcome. However, the higher dead space (i.e. 18 L/min) and rebreathing rate observed during helmet NIV make such results not applicable to this particular setting. The investigators designed a randomized-crossover trial to assess the effect of four humidification strategies during helmet NIV on patients with acute respiratory failure, in terms of comfort, work of breathing and patient-ventilator interaction. Methods. All awake, collaborative, hypoxemic patients requiring mechanical ventilation will be considered for the enrollment. Hypercapnic patients (i.e.PaCO2>45 mmHg) will be excluded. Each enrolled patient will undergo helmet NIV with all the following humidification strategies in a random order. Each period will last 60 minutes. Passive humidification, double tube circuit. Heated humification (MR 730, Fisher & Paykel, Auckland, New Zealand), humidification chamber temperature 33°C. Heated humification (MR 730, Fisher & Paykel, Auckland, New Zealand), humidification chamber temperature 37°C. Passive humidification with HME, Y-piece circuit. Ventilatory settings (Draeger Evita xl or Evita infinity ventilators): Pressure support ventilation; pressure support=20 cmH20; FiO2 titrated to obtain SpO2 between 92 and 98%; positive end-expiratory pressure=10 cmH2O; maximum inspiratory time 0.9 seconds; inspiratory flow trigger = 2 l/min; expiratory trigger: 30% of the maximum inspiratory flow; pressurization time=0,00 s. Such settings will be kept unchanged during the whole study period. An oesophageal catheter will be placed and secured to measure oesophageal pressure (Pes) and gastric pressure (Pga) (Nutrivent, Italy): the reliability of the measured pressure will be confirmed with an airway occlusion test during NIV with oronasal mask. Work of breathing will be estimated with the pressure-time product (PTP) of the pleural pressure. A pneumotachograph (KleisTek) will record flow, airway pressure, Pes and Pga on a dedicated laptop. At the end of each cycle, the patient will be asked to rate his/her discomfort on a visual analog scale (VAS) modified for ICU patients. The level of dyspnea will be assessed with the Borg dyspnea scale. The following parameters will be record at the end of each cycle: Arterial pressure, heart rate, respiratory rate, SpO2, pH, PCO2, PaO2, SaO2. Airway and esophageal pressure signals will be reviewed offline to detect patient-ventilator asynchronies (ineffective efforts, double cycling, premature cycling, delayed cycling) and asynchrony index (number of asynchrony events divided by the total respiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts) will be computed. The trigger delay will be also measured. The pressurization and depressurization velocity will be assessed with the PTP airway index 300 and 500 (inspiratory and expiratory), as suggested by Ferrone and coworkers. The work of breathing (WOB) for each breath will be estimated by PTPes. An hygrometer (Dimar SRL, Italy) will measure and record on a dedicated laptop Helmet temperature, relative and absolute humidity. Primary endpoints: patient's comfort, work of breathing and asynchrony index. Sample Sizing: Given the physiological design of the study, the investigators did not make an a priori sample size and plan to enroll 24 patients.

The aim of the present study; To compare the effects of respiratory support options available for NIMV at the emergency department; i.e. AVAPS and ST/T modes, on the patient's pCO2 values, additional treatment need (another non-invasive ventilation method or endotracheal intubation) and the duration of stay in hospital.

Multicenter, phase IV, registry-based, randomized controlled trial. Patients starting long-term oxygen therapy (LTOT) are randomized between LTOT prescribed 24 h/day or 15 h/day using the Swedish Register for Respiratory Failure (Swedevox). Clinical follow-up and concurrent treatments are according to routine clinical practice. The main endpoints of mortality, hospitalizations, and incident disease are assessed using Swedish registry data, with expected complete follow-up. Patient-reported outcomes are assessed using a posted questionnaire at 3 and 12 months. The study is managed by the Uppsala Clinical Research Centre (UCR).

The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo device-related effects (sham-Bi-PAP) were investigated.