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43 active trials for Mechanical Ventilation Complication

Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients

Although tracheostomy is a common technique in Intensive Care Units (ICU), its complications can be frequent (between 5% to 40%). Inadequate fixation could favor decannulation, as well as incorrect alignment of the tracheostomy with respect to the tracheal axis could favor the appearance of tissue alterations such as ulcers, bleeding or fistulas, as well as obstruction of the ventilatory obstruction. Having a device that is effective in fixation and alignment could help in reducing tracheostomy complications, so this study aims to evaluate the effect and safety of a fixation device for tracheostomy through a randomized clinical trial.

Start: November 2019

PReventing the EffectS of Intubation on DEglutition

An early intervention for swallowing disorders (i.e., dysphagia) during endotracheal intubation may improve patient outcomes. The investigators propose treatment sessions targeting sensorimotor integration, strength, and range of motion during oral endotracheal intubation with mechanical ventilation to reduce or prevent dysphagia and aspiration (food or liquids entering the airway), establish a solid foundation in understanding reasons for swallowing impairment after extubation from mechanical ventilation and learn new methods to reduce or prevent these problems.

Start: July 2015

Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity

The study consists in determine the transpulmonary pressure in morbidly obesity patients that require mechanical ventilation. both gender only adults Medical intensive care patients.

Start: January 2018

Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients

Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described. This crossover physiology study will include 18 tracheostomized patients ventilated for more than 72 hours. The objective of this study is to compare the effect of three different modalities of SBTs on respiratory effort in tracheostomized patients. The modalities tested are : Pressure Support Ventilation (PSV level 5 cmH2O, PEEP 5 cmH2O), T-piece test and high-flow Oxygen. Each modality is applied in a randomized order, during 30 minutes. During every modality tested, esophageal and gastric pressure, expired CO2, and comfort will be monitored, in addition to standard monitoring. Based on esophageal pressure monitoring, patient's respiratory efforts can be calculated either by esophageal pressure-time product and work of breathing. Pressure generated by inspiratory muscles will also be assessed.

Start: March 2019

Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients

The goal of this interventional crossover study, in intubated and mechanically ventilated Acute Respiratory Distress Syndrome (ARDS) patients, is to compare two positive end-expiratory pressure (PEEP) titration techniques regarding: respiratory mechanics, gas exchange, changes in aeration, ventilation/perfusion matching its impact on cardiac function, especially the right heart (RH). The PEEP titration techniques are: PEEP selection based on low PEEP/high FiO2 table ("PEEPARDSnet") and lung recruitment maneuver (LRM) plus PEEPdec titration based on the best compliance of the respiratory system("PEEPLRM").

Start: June 2019

Lowering PEEP: Weaning From High PEEP Setting

The perfusion of the deeply different areas coexisting in ARDS lung generates two type of venus-admixure : true shunt and shunt effect. Briefly, true shunt and shunt effect are related to non-aerated and poorly-ventilated lung areas perfusion respectively. Practically, it is not possible to quantify the true shunt and the shunt-effect directly, but we can measure the "total-shunt", i.e. the sum of two kind of venus-admixured. As it is known from classical physiology, the effects of FiO2 variations on PaO2 are deeply different depending on the type of venous admixures. In the case of a patient with virtually only true shunt, any FiO2 variation will not modify the PaO2. On the other hand, in a patient with virtually only a shunt effect, increasing the FiO2 the PaO2 will progressively increase. Indeed, ventilating a patient presenting only a shunt effect (without true shunt) with pure oxygen will generate a "normal" P/F ratio. In patients ventilated with high PEEP levels it is difficult to predict based on the P/F ratio the relative amount of true shunt and shunt effect. However, patients presenting a significant shunt effect when ventilated with higher PEEP level would likely have "unstable" poorly aerated lung areas that need PEEP to remain opened. In those patients, a PEEP-weaning protocol based on the P/F ratio could induce significant alveolar de-recruitment and clinical deterioration. On the contrary, patients with less shunt effect would be likely less prone to alveolar de-recruitment and would benefice from PEEP decrease.

Start: September 2019

A New Ultrasonographic Tool to Assess Pulmonary Strain in the ICU

The primary objective of the study is to create a small dataset of regional pulmonary strain values in patients suffering from pulmonary diseases under mechanical ventilation in an intensive care setting. Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the determination of local pleural strain in 4 predetermined pulmonary areas in mechanically ventilated patients suffering from pulmonary diseases.

Start: March 2018

INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring

Background INTELLiVENT-ASV, an automated closed-loop mode of mechanical ventilation, available on Hamilton ventilators for clinical use, uses mainstream end-tidal CO2 (etCO2) monitoring to adjust minute ventilation. However, sensors for mainstream etCO2 monitoring are expensive and fragile. The less expensive and more robust sensors for sidestream etCO2 monitoring could serve as a good alternative to sensors for mainstream etCO2 monitoring. Objective of the study The objective of this randomized noninferiority trial is to determine whether INTELLiVENT- ASV with sidestream capnography is noninferior to INTELLiVENT-ASV with mainstream capnography with regard to the percentage of breaths in a broadly accepted predefined 'optimal' zone of ventilation. Hypothesis The investigators hypothesize that INTELLiVENT-ASV with sidestream capnography is noninferior to INTELLiVENT-ASV with mainstream capnography with respect to the percentage of breaths a patient spends within the 'optimal' zone of ventilation. Study design INTELLiSTREAM is a randomized noninferiority study. Study population The study population consists of consecutive elective cardiac surgery patients who are expected to need at least 2 hours of postoperative ventilation in the ICU of Amsterdam Medical University Centers, location 'AMC'. Intervention Shortly after arrival at the ICU, patients will be randomized to receive either ventilation with INTELLiVENT-ASV with mainstream capnography or sidestream capnography. Primary outcome of the study The primary study endpoint is the percentage of breaths a patient spends inside the 'optimal' zone of ventilation, as defined before (i.e. tidal volume < 10 ml/kg PBW, maximum airway pressure < 30cm H2O, etCO2 between 30-46 mmHg and pulse oximetry between 93-98%). Secondary outcomes The percentage of time spent in other ventilation zones, as defined in the protocol. Time to spontaneous breathing, duration of weaning, loss of etCO2 signal, duration of postoperative ventilation and ventilator parameters as well as results of clinically indicated arterial blood gas analysis. Nature and extent of burden and risks associated with participation, benefit and group relatedness Hamilton ventilators can use mainstream and sidestream etCO2 sensors. INTELLiVENT-ASV is a safe mode of ventilation, also in patients who receive postoperative ventilation. Furthermore, as all patients are sedated as part of standard care during postoperative ventilation, the burden for the patient is minimal

Start: June 2020

Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound.

Critically ill children treated with invasive mechanical ventilation (iMV) in a paediatric intensive care unit (PICU) may suffer from complications leading to prolonged duration of ventilation and PICU stay. Prolonged ventilation is associated with haemodynamic dysfunction, neuromuscular insufficiency, malnutrition, metabolic disorders and diaphragmatic muscle weakness. Evidence from adult critical care supports the existence of ventilator induced diaphragmatic dysfunction, defined as a iMV-induced loss of diaphragmatic force - generating capacity - characterised by muscle fibre atrophy, myofibril necrosis and disorganization. Diaphragm function or contractility can be assessed by measuring the diaphragm thickening during inspiration and expiration with ultrasound and is expressed as a thickening fraction (TF). A low diaphragm contractile activity in adults has been associated with rapid decreases in diaphragm thickness, whereas high contractile activity has been associated with increases in diaphragm thickness. Contractile activity decreased with increasing ventilator driving pressure and controlled ventilator mode. Maximal thickening fraction (a measure of diaphragm function) was lower in patients with decreased as well as increased diaphragm thickness than in patients with unchanged thickness (p=0.05). Titrating ventilatory support to maintain normal levels of inspiratory effort may prevent changes in diaphragm configuration associated with iMV, but more research is needed to confirm this supposition. Only one study has shown the presence of diaphragm atrophy in critically ill children on iMV for acute respiratory failure. The diaphragm contractility, measured as thickening fraction, was strongly correlated with a spontaneous breathing fraction. Norm data for diaphragmatic thickness and TF in children are only available for healthy neonates (n=15) and children (n=48) from 8 till 20 years of age. The purpose of this study is to determine values of normal diaphragm thickness and TF in children aged 0-8 years by ultrasound. This age range reflects the largest patient group treated in the PICU. Once these values are known, the clinical relevance of the measuring of the diaphragm thickness of ventilated children by ultrasound can be further studied. Objective of the study: Primary objective: To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age. Secondary objective: To determine the interrater reliability of operators performing the ultra-sound Study design: prospective, cohort study. Study population: Healthy children in four age groups: 0-6 months; 6 months-1 year; 2-4 years; and 5-8 years. Participants will be recruited in two ways: Group 1. Parents of children scheduled to undergo a daycare procedure will asked permission for their child to join the study. These children undergo a minor procedure and are assumed to have a normal diaphragm; therefore are considered 'healthy''. Group 2. Health professionals working on the PICU or other departments of Erasmus MC-Sophia as well as family, friends and neighbours of members of the research group will be asked to recruit 'healthy' children. The investigators will recruit participants by means of brochures in which children and/or caregivers are invited to contact the researchers when interested to participate in this study. Primary study parameters/outcome of the study: To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age. Secondary study parameters/outcome of the study (if applicable): To determine the interrater reliability of operators performing the ultra-sound

Start: September 2020

Diaphragm Ultrasound as a Powerful Tool in Managing Acute Hypoxemic Respiratory Failure in Hematological Patients

Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. Mechanical ventilation is frequently needed and diaphragm activity has to be assessed not to worsen ventilator-induced lung injury.

Start: May 2019

Cycling Exercise in Mechanical Ventilation

Prolonged critical illness renders survivors with increased long-term morbidity associated with high healthcare costs. Muscle weakness and fatigue are reported as the main contributors to long-term poor functional outcomes. Emerging evidence for early mobilisation demonstrates reduction in the number of ventilator days and hospital length of stay. It has been demonstrated that daytime motoring (passive and active) can improve functional capacity in intensive care patients. The aim of the proposed study is to evaluate the effect of cycling exercise in patients on mechanical ventilation appointed to weaning process.

Start: May 2017

Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM)

Non-Invasive Mechanical Ventilation (NIV) has been increasingly used in the treatment of acute respiratory failure. Notwithstanding failure rates still remains high, ranging from 5% to 60%. The onset of delirium, agitation, pain and dyspnea may contribute to reduce the success rate of non invasive ventilation treatment. The aim of this study is to assess the incidence and impact of delirium, agitation, pain and dyspnea on clinical outcomes in a population of patient admitted to Respiratory Intensive Care Unit undergoing Non-Invasive Mechanical Ventilation for Acute Respiratory Failure.

Start: August 2019

Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant

This study is designed to characterize the changes in diaphragm structure, function and biology during bridging to lung transplant by mechanical ventilation or extracorporeal life support.

Start: April 2019

Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.

Start: July 2020

Effect of the Intra-abdominal Pressure on the Risk of Delirium in Mechanically Ventilated Patients.

intra-abdominal hypertension (IAH) and delirium are serious, high-frequency complications in intensive care unit (ICU) patients. The consequences of the complication range from high morbidity and mortality to a greater need for nursing care. We hypothesize that there could be a correlation between IAH and incidence of delirium.

Start: July 2016

Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis

Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP).

Start: February 2018

Semirecumbent Position by Mechanical Ventilation

It's based in an observational trial in mechanical ventilated patients. The investigators assess the head of bed elevation angle in the routine treatment of the unit. The investigators decide to assess the time the patient has a semirecumbent position >35°.

Start: January 2020

Heartrate Variability During Conventional and Variable Pressure Support Mechanical Ventilation

Rationale Studies show that about a third of all postoperative complications are due to cardiovascular reasons. Furthermore it was shown that more than 50% of postoperative deaths are associated with severe cardiovascular incidents. After surgical interventions seriously ill patients are transferred to intensive care units and mechanically ventilated. However there is not much evidence about the impact of mechanical ventilation on the cardiovascular system and cardiovascular complications. Artificial mechanical ventilation greatly differs from physiological breathing. In contrast to physiological negative pressure ventilation of th lung, mechanical positive pressure ventilation can cause ventilator induced lung injuries. Furthermore a significant deterioration of lung-heart-interaction during mechanical ventilation is known. Relevance Mechanical ventilation leads to a decreased heartrate-variability, which has to be understood as increased stress on the cardiovascular system. Recently, a new ventilation mode called "variable pressure support ventilation" (VPSV) also known as "noisy pressure support ventilation". This new ventilation mode is similar to the ventilator mode "spontaneous-continuous positive airway pressure/pressure support" (SPN-CPAP), which is often used in a intensive care unit routine. Though VPSV differs through varying applicated pressure support and therefore tidal volumes. Therefore the new ventilation mode rather imitates physiological situation, since tidal volumes vary in physiological breathing, which has positive impact on heart-lung-interaction.

Start: February 2018

National Approach to Standardize and Improve Mechanical Ventilation

This is a pre-post implementation cohort study. This is a data driven quality improvement project which aims to improve the care of mechanically ventilated patients through the implementation of a bundle of evidence based practices, with a goal of reducing ventilator associated events and mortality.

Start: January 2019

Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC

Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured. After that mode will shift to Bilevel Volume Guarantee mode for two hours than clinical and other parameters will be checked again. After this intervention, patients will allocated to PRVC or Bilevel VG group for remaining time.

Start: December 2019