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43 active trials for Mechanical Ventilation Complication

Diastolic dYsfunctioN AssessMent in critICally Ill Patients

The role of the left ventricular diastolic function (LVDD) in the weaning failure from mechanical ventilation in unclear. Specifically, is unclear whether the outcome of the weaning process could be affected by a pre-existing LVDD (before ICU admission), or by the worsening of a chronic pattern, or by a de-novo LVDD presentation.

Start: June 2021

Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation

The principal objective of the CONFIDENT trial is to assess the efficacy of two units (400-500 mL in total) of convalescent plasma, as compared to Standard of Care (SoC), to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.

Start: September 2020

A Problem Solving Intervention for Post-ICU Cognitive Impairment in Older Adults

This study will apply an evidence based program to assist ICU survivors to overcome cognitive problems as a result of their critical illness. This study will determine feasibility of recruitment, retention and engagement with the program as well as acceptability of the program to the participants.

Start: May 2021

Effect of Diaphragm Stimulation During Surgery

During major surgical procedures general anesthesia is used to make the patient unconscious. General anesthesia insures that the patient is unaware of any pain caused by surgery. General anesthesia also prevents the patient from moving to prevent any potential surgical error. At the same time general anesthesia makes it impossible for the patient to breathe. To help the patient breathe a breathing tube is placed into the patient's airway and connected to the mechanical ventilator. A mechanical ventilator is an artificial breathing pump, which delivers gas into a patient's airways. The purpose of this research study is to determine if brief periods of diaphragm stimulation can prevent diaphragm problems caused by the use of mechanical ventilators and surgery. To answer this question the changes in the genes responsible for maintaining diaphragm function will be studied. A gene is the code present in each cell in your body and controls the behavior of that cell. In addition, the changes in the contractile properties of muscle fibers will be studied. The results from this study may help develop new treatments to prevent diaphragm weakness resulting from mechanical ventilation use.

Start: February 2018

Incidence, Risk Factors and Outcomes of Diaphragm Dysfunction After Lung Transplantation

The study is designed to characterize the changes in diaphragm function after lung transplantation.

Start: February 2020

Determination of Normal Values of Regional Pulmonary Strain Using a New Ultrasonographic Tool in Healthy Volunteers

Mechanical ventilation is frequently used in the operating room and the intensive care settings. Although essential in many cases, mechanical ventilation can be responsible for ventilator-induced lung injury (VILI). The relationship between mechanical ventilation and VILI has been clearly demonstrated in animals and is highly suspected in humans. The putative mechanism responsible for VILI is excessive pulmonary strain or overdistension. Frequently observed in mechanically ventilated patients, the presence of a severe pre-existing pulmonary disease can increase the risk of overdistension. The development of a tool allowing early detection of pulmonary overdistension would represent a great asset in the prevention of VILI by allowing safer adjustments of mechanical ventilation parameters. Ultrasonographic imaging is a non-radiant, non-invasive technique already available in the intensive care setting. Already used for cardiac strain measurements, ultrasonography is a promising avenue to assess pulmonary strain.This study will aim to establish normal pleural strain values using ultrasonography in healthy volunteers. Purpose: The primary objective is to calculate 95% confidence intervals in pleural strain for a set of 5 inspired volumes at 4 predetermined lung areas in healthy volunteers. The secondary objectives of the study are: to modelize the relation between pleural strain and inspired volume to modelize the relation between pleural strain and global pulmonary volumetric strain to modelize the relation between pleural strain and maximal echo intensity change to compare the regional distribution pattern of pleural strain in healthy volunteers in dependent versus non-dependent areas. Hypothesis: Elastography using the Lagrangian speckle model estimator based on optical flow allows the determination of normal mean values and 95% confidence intervals of pleural strain (average Von Mises coefficient) in 4 predetermined lung areas for a set of 5 inspired volumes in healthy volunteers.

Start: July 2021

Lung and Diaphragm-Protective Ventilation by Means of Assessing Respiratory Work

This study is designed to test a proposed strategy for lung- and diaphragm-protective ventilation (LDPV) in patients with acute hypoxemic respiratory failure. Ventilation and sedation will be titrated to evaluate whether it is feasible and safe within this patient population.

Start: February 2019

Determinants of Implementation Success Coordinating Ventilator, Early Ambulation and Rehabilitation Efforts

There is a fundamental gap between the discovery of proven-effective intensive care unit (ICU) sedation, mechanical ventilation, mobility, and symptom management strategies and approaches that can equip ICU providers with the skills necessary to reliably adopt these interventions in everyday practice. Until this gap is filled, the millions of patients with heart, lung, and blood disorders admitted to ICUs annually will remain at risk for avoidable physical, mental, and cognitive health impairments that may persist for months to years after hospital discharge. In the proposed study, the investigative team will continue their partnership with the Society of Critical Care Medicine's (SCCM's) ICU Liberation Collaborative. Guided by the Consolidated Framework for Implementation Research, the overall objective of the Determinants of Implementation Success Coordinating Ventilator, Early Ambulation and Rehabilitation Efforts in the ICU (DISCOVER-ICU) study is to develop multilevel implementation strategies to enhance sustainable adoption of the ABCDEF (Assess, prevent, and manage pain and delirium, both spontaneous awakening and breathing trials, choice of sedation, early mobility, family engagement) bundle in routine ICU practice. Using a multiphase, sequential, mixed-methods design, this study has three specific aims: 1) estimate the effects of patient-level characteristics on ABCDEF bundle adoption; 2) examine unit-level variation in ABCDEF bundle adoption and associated provider- and organization-level characteristics; and 3) determine which implementation strategies result in the greatest adoption of the ABCDEF bundle. Existing deidentified data will be obtained from >15,000 patients, >5,000 interprofessional ICU team members, and 68 hospitals participating in the ICU Liberation Collaborative to achieve specific aims 1 and 2. For specific aim 3, data collection will be extended using interprofessional ICU team surveys, a modified Delphi process, and concept mapping to achieve greater understanding of implementation strategies that prove most effective for ABCDEF bundle adoption. Results of this work will directly lead to the development of implementation strategies that are adaptable, responsive to community needs, and account for the cultural and organizational factors necessary to increase ABCDEF bundle adoption. These implementation strategies will then be tested in a future cluster randomized hybrid II implementation effectiveness trial.

Start: January 2020

Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy

The objective of the study is to determine how controlled mode ventilation and support mode ventilation impact ventilator-free days and diaphragmatic atrophy.

Start: March 2019

Preoperative Inspiratory Muscle Training

In light of the corona virus pandemic (COVID-19), there is critical need to conserve scarce mechanical ventilation (MV) resources. This study evaluates an intervention in non-infected cardiac patients as a means to assist with minimizing MV and ICU length of stay (LOS). Pre-op inspiratory muscle training (IMT) has been shown to decrease pulmonary complications, MV dependence, and ICU LOS following thoracic surgery. The investigators aim to determine the mechanism of remodeling in diaphragms of adults who undergo pre-op IMT.

Start: June 2021

Anakinra, COVID-19, Cytokine Storm

The clinical syndrome associated with infection of the Coronavirus Disease 2019 (COVID-19) is notable for its variable clinical expression. Infection and transmission of the virus by asymptomatic individuals have been noted and represent one end of the clinical spectrum, while multi-organ failure, particularly pulmonary failure, and death represent the most severe end of the clinical spectrum. In a recent study published from the investigator's institution about the first 393 patients with COVID-19, 77.1% had a fever, a mechanism driven by IL-1. This suggests that there may be an excess release of IL-1 present. Cytokine storm syndrome (CSS) has been observed in patients with COVID-19 and has been proposed to contribute to the acute pulmonary failure that occurs. In distinct clinical settings, macrophage activation syndrome, elevated levels of pro-inflammatory cytokines, including IL-1, IL-6, and others, as well as elevations in laboratory indicators, including ferritin, CRP, d-dimer, and lymphopenia, have been observed. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses. Anakinra, a recombinant IL-1 receptor antagonist, has shown promise in treating CSS. It inhibits both IL-1-alpha and IL-1-beta. It is an FDA approved medication used in rheumatoid arthritis (RA) and Cryopyrin-Associated Periodic Syndromes (CAPS). Anakinra's ability to inhibit both IL-1 subtypes and short half-life makes it favorable to some experts. In the investigator's case-series, using anakinra in patients with COVID-19 showed promising in preventing the need for mechanical ventilation, and mortality subsequently. This study will determine the efficacy of anakinra, an interleukin (IL) -1 receptor blocker, in reducing the need for mechanical ventilation and/or 28-day mortality among patients with COVID-19 who have features of CSS and severe respiratory failure. The investigators will test the hypothesis that the proportion of subjects with COVID-19, features of CSS, and severe respiratory failure (World Health Organization (WHO) category 4 or 5) alive and without having required mechanical ventilation at day 28 from randomization will be 18% higher among those that receive anakinra compared to those that receive a placebo. A secondary hypothesis is that the number of subjects alive at 60-days will be higher amongst those who receive anakinra compared to those who receive a placebo.

Start: July 2021

Reiki Intervention for Seriously Ill Elders Intensive Care Unit (RISE-ICU)

The overall objective of this proposal is to demonstrate the feasibility of conducting a future large-scale, randomized controlled trial (RCT) to test whether Reiki is superior to sham Reiki and usual care when delivered to critically ill older adults who require mechanical ventilation (MV). Our three-arm, pilot RCT will include 45 subjects and their LARs (45) recruited from the Ohio State University Wexner Medical Center (OSU-WMC) intensive care units (ICUs) who are randomly allocated 1:1:1 to: 1) Reiki, 2) sham Reiki, or 3) usual care for 5 days or until the subject is discharged from the hospital or expires. The Investigators will perform interviews with the subjects' LARs upon study enrollment to determine the subjects preadmission physical, functional, and cognitive health status. Each subject will be assessed for pain, anxiety, and agitation and have their vital signs taken daily for 5 days using valid and reliable tools. Medical records will be used to record demographic and clinical characteristics. The Investigators will survey each subject and their LAR regarding their experiences with the Reiki, sham Reiki or usual care sessions. Reiki and sham Reiki will be administered for 5 consecutive days even if the subject is transferred to the floor from the ICU. Usual care will also involve a 5-day period. Study Arms. Reiki. Three professional Reiki therapists trained at Level 2 (intermediate) and with a minimum of 2 years of Reiki practice will administer the Reiki intervention. Sham Reiki. Three actors will administer sham Reiki. Usual Care. Subjects assigned to usual care will not receive Reiki or sham Reiki. The usual care group will undergo the same in-person symptom assessments and electronic health record (EHR) reviews as the Reiki and sham Reiki groups. Reiki therapy is not part of usual care in the participating ICUs. The knowledge gained from this study will contribute to a better understanding of how/if a nonpharmacologic intervention can reduce the symptoms experienced by critically ill older adults.

Start: October 2018

Effects of NMES in Critically Ill Patients

Muscle wasting occurred early and rapidly in critically ill patients. Early therapeutic strategies to either maintain muscle structure and function should be encouraged. Neuromuscular electrical stimulation (NMES) is an attractive intervention to maintain muscle mass and strength in critically ill patients during the first week of ICU stay. This study will test the hypothesis that the number of contraction per day evoked by NMES in the first two weeks of illness may influence in muscle wasting, with beneficial effects on the physical and functional status in mechanically ventilated patients.

Start: February 2021

Post-extubation Assessment of Laryngeal Symptoms and Severity

The goal of this study is to learn more about voice and airway problems that patients experience during and after the time patients have an oral endotracheal tube in patients' airway to help patients breathe while receiving mechanical ventilation in an intensive care unit (ICU).

Start: February 2019

How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

The objective is to compare the impact of early mobilization and routine care on diaphragm thickness in critically ill children

Start: May 2021

Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction

Clinical evaluation of a new educative tools (Smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation.

Start: November 2019

Development of a Multimodal Index to Improve the Predictive Value of Success in Weaning From Mechanical Ventilation

Weaning from mechanical ventilation (MV) is a complex process in which patients are liberated from the ventilator. Prolongued weaning and weaning failure, defined as the need for reintubation, have different adverse effects, including prolongation of MV, intensive care unit (ICU) and hospital stay, and are also associated with increased incidence of ventilator-associated pneumonia and high mortality. The rate of weaning failure is high, even when the classic extubation criteria are met, so it is necessary to improve scores that allow predicting and determining the ideal time for MV withdrawal. The aim of this study is to design a new multimodal index to predict and optimize weaning results in a personalized way, based on the use and interpretation of data derived from continuous monitoring of critically ill patients. The new multimodal index, in addition to classical respiratory parameters, will include parameters related to patient-ventilator interaction (asynchronies), diaphragmatic function, cardiovascular status and autonomic nervous system function (ANS). The investigators have designed a prospective observational study that will include 126 critical patients from a medical-surgical ICU that meet the classical criteria for weaning. The management of the patients, as well as the weaning process, will be carried out following the usual protocol. In addition to the classical weaning predictor data, data on the patient-ventilator interaction and the function of the autonomic nervous system will be collected by means of specific software (BetterCare). Cardiovascular and diaphragmatic function will be evaluated using ultrasound. Based on the advanced analysis of data from different devices collected throughout the mechanical ventilation period, it will be designed a "personalized" weaning score that should improve the accuracy of the decision-making process and therefore reduce morbidity and mortality. Additional benefits would include lowering health care costs without increasing adverse events.

Start: April 2021

The REDEEM Pilot Study: A Feasibility RCT of Early ECMO in Severe Acute Respiratory Infection, Including COVID-19, WHO

Patients who are critically ill in intensive care with moderate to severe acute respiratory infection often require mechanical ventilation. Prolonged ventilation increases the risk of lung damage and other side effects as a result of long term use of sedation medications. Extracorporeal membrane oxygenation therapy (ECMO), is a relatively new technology that uses a pump to remove blood from the body and return it back to the body after adding oxygen and removing carbon dioxide. ECMO can be used on patients who require mechanical ventilation and can function without the need for ongoing mechanical ventilation, thus reducing risk of side effects. Participants will be randomised into either the early ECMO therapy group or will continue standard treatment involving mechanical ventilation. This pilot study aims to determine if a phase 3 Randomised Control Trial (RCT) is feasible for the use of early ECMO therapy to treat patients with Severe Acute Respiratory Infection (SARI). The success of the study will be determined by the successful recruitment of adult patients, that there is a difference between ECMO utilisation between groups and that there are no safety issues.

Start: February 2021

Gastric Ultrasound to Monitor Gastric Residual Volume

It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation. Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed gastric emptying that may lead to regurgitations, vomiting, pulmonary aspiration, and potentially increased risk of ventilator-associated pneumonia (VAP). Residual gastric volume (RGV) measurement had been recommended to monitor the tolerance to enteral nutrition in mechanically ventilated patients receiving early enteral feeding. Nevertheless, several studies have challenged the usefulness of such RGV monitoring, showing that it led to reduced caloric intake without any benefits in terms of reducing the occurrence of vomiting and the incidence of VAP. This lack of relationship between RGV monitored using gastric suctioning and the occurrence of regurgitation, aspiration and pneumonia may reflect the inaccuracy of the aspiration method used for the measurement of the RGV, as it has been reported in adult patients. Gastric ultrasonography is a non-invasive and easy-to-use tool allowing accurate preoperative assessment of gastric contents, based on both qualitative examination of the gastric antrum and calculation of gastric content volume. Ultrasound examination of the antrum could therefore constitute an alternative to gastric suctioning for the monitoring of RGV in intensive care unit patients. This prospective study aims to assess the reliability of the RGV monitoring based on gastric suctioning compared to ultrasound technique. Secondary endpoint is to assess whether increased gastric volume, aspirated or calculated by ultrasound, is an independent risk factor of regurgitation and / or vomiting.

Start: May 2020

Left Ventricular Diastolic Dysfunction as a Predictor of Weaning Failure From Mechanical Ventilation

Both premature and delayed extubation prolong the duration of mechanical ventilation and the intensive care unit (ICU) length of stay and increase morbidity and mortality. Therefore, accurate prediction of postextubation distress and the early diagnosis of the causes responsible for failure of a trial of pressure support ventilation are of paramount importance to improve the outcome of mechanically ventilated patients in the ICU. This observational study is designed to test the ability of cardiac and diaphragm function assessed by bedside ultrasound to predict extubation failure within 48 h and re-intubation within 1 week after extubation.

Start: August 2020