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100 active trials for Respiratory Failure

How Does Patients' Overall Assessment of Their Health Vary Across and Within Different Disease Groups?

EQ-5D is one of the most commonly employed patient-reported outcome (PRO) measures. It is included in many of the Swedish National Quality Registers (NQRs). EQ-5D health states are usually summarized using 'values' obtained from healthy members of the general public. However an alternative - which remains to be studied in detail - is the potential to use patients' self-reported overall health on the visual analogue scale as a means of capturing experience-based values. The overall aim of this project is to increase knowledge on the potential applicability of EQ VAS as a health state valuation method through assessment of its variability across and within patient groups and compared with that of the general population in Sweden. Data on nearly 700,000 patients from 12 NQRs covering a variety of diseases/conditions and from the general population will be analysed. Longitudinal studies of PROs among different patient groups will be conducted at baseline/first visit and 1-year follow-up. Descriptive analyses comparing EQ-5D health states and observed self-assessed EQ VAS within and across registers will be performed. Comparisons of the change in health state and observed EQ VAS values over one year will also be made. Regression models will be used to assess whether EQ-5D dimensions predict observed EQ VAS values to investigate patient value sets in each NQR. These will be compared across the patient groups and with the existing Swedish experience-based VAS and time trade-off (TTO) value sets obtained from the general population. This research project will provide information on the variation among different patient groups in terms of self-reported health status through EQ VAS and comparison with the general population. Knowledge on the relative importance of different dimensions of the EQ-5D to different patient groups as well as the general population will be gained in this project. The possibility of getting value sets based on patients' self-reported EQ VAS values and their comparison with value sets from experience-based general population studies will be discussed.

Start: January 2002

COVID-19 in Liver Transplant Recipients

Prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of COVID-19 in LT in Spain.

Start: March 2020

Non-Invasive Monitoring of Respiratory Function in Spontaneously Breathing Patients With COVID-19 Infection

This study uses the AirGo band to monitor changes in tidal ventilation in spontaneously breathing patients with COVID-19 associated respiratory failure. It aims to recognize patterns of ventilation associated with worsening respiratory failure in this patient population. If successful, this study will lead to the development of new robust methods for real-time, continuous monitoring of respiratory function in patients with respiratory failure. In turn, such monitoring methods may enable improvements in the medical management of respiratory failure and timing of interventions.

Start: April 2020

Healthcare Renunciation in Respiratory Chronic Disease and Treatment Compliance (OBSERVE)

Health care renunciation is a factor that can alter patients' health status and increase the costs of its support. To date, there is no national data on the renunciation of care. This study will initially characterize the different forms of health care renunciation in patients with chronic respiratory diseases, treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) , and analyze it impact on treatment compliance and health processes. The follow-up of these patients during 5 years will define renunciation trajectories (transition from the state of "renouncing" to "non-renouncing" and vice versa) and their impact on treatment compliance. The investigators hypothesize that a patient becoming renounced on a given treatment also decreases his treatment compliance (CPAP or NIV ). The impact of the renunciation trajectory on the patient's follow-up in terms of hospitalizations and deaths will also be studied.

Start: June 2018

'Single Hand Used inTubaTing Laryngoscope Evaluation' Study

This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope

Start: January 2020

Critical Respiratory Diseases in Ex-preterm Infants in PICU

Premature birth is the leading cause of death in children younger than 5 years old worldwide, especially in low- and middle-income countries. Premature infants who survive are at greater risk of a range of short-term and long-term health consequences. Common long-term health morbidities among children who are born prematurely include cerebral palsy, infections (particularly respiratory infections), bronchopulmonary dysplasia, feeding difficulties, hypoxic-ischemic encephalopathy, visual and hearing problems. Re-hospitalization occurs frequently during first few years of life among ex-premature infants with respiratory illness. This leads to increased financial burden for health care system and families. The impact of prematurity on the health care system, especially on pediatric intensive care units (PICUs) has mainly been evaluated in high income countries. Little is known about long term health outcomes of ex-premature infants and their impact on the cost to health care system in low- and middle-income countries. This pilot, single institution, observational study aims to determine the prevalence, course of the diseases, and outcomes of ex-premature infants with respiratory illnesses who are admitted to a PICU of a tertiary children's hospital in Vietnam. Investigators will determine the epidemiology of respiratory illness, and the resource utilization for these children in the PICU. To achieve these aims, the investigators will prospectively screen and recruit all children aged less than 2 years old admitted to the PICU with respiratory illness/failure and collect pertinent clinical data. The study participants will be follow-up until PICU discharge.

Start: November 2019

High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study

The goal of this study is to evaluate the role that high-flow nasal cannulas (HFNC) have on respiratory drive, work of breathing and neuromuscular efficiency after lung resection surgery. The main question the investigators aim to answer is whether HFNC decrease respiratory drive by at least 15% in these patients, assessed by a special diaphragmatic electromyography (EMG) device (NAVA catheter). In order, to perform this study, the investigators will perform a physiological study in 40 patients. These patients will be assessed in the immediate postoperative period and HFNC will be compared to conventional face-mask therapy.

Start: February 2020

Tolerability, Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease

Non-invasive mechanical ventilation (NIMV) is the recommended standard of care as initial therapy for patients with motor neuron disease (MND) with deterioration of the respiratory function. SIGH_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with MND in comparison to the standard ventilation support protocol.

Start: May 2018

Steroid Resistance During COPD Exacerbations With Respiratory Failure

Chronic obstructive pulmonary disease (COPD) is a lung disease caused by cigarette smoke that affects millions of people. In the United States, COPD is the 3rd leading cause of death making it one of our most important public health problems. Some people with COPD get disease flares that are called acute exacerbations of COPD - or AECOPDs for short. When people get an AECOPD they experience increased shortness of breath, wheezing and cough; symptoms that often require urgent or emergent treatment by healthcare providers. In the most severe, life-threatening situations, people with AECOPDs are put on a ventilator in the emergency department and admitted to the intensive care unit. Most AECOPDs can be treated with low doses of medications called steroids. This is good because high doses of steroids can cause unwanted side effects. Unfortunately, recent studies suggest that the sickest people, those admitted to the intensive care unit needing ventilator support, need higher doses of steroids because they may have resistance to these important medications. The investigators are studying steroid resistance during very severe AECOPDs so that we can eventually develop better and safer therapies for these vulnerable people.

Start: July 2017

Clearance Of Mucus In Stents (COMIS)

The goal of this clinical research study is to compare the effects of sodium bicarbonate to normal saline when used for clearing mucus blockage in patients with airway stents.

Start: June 2011

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

Clinical Assessment Method in Patients Using Non-invasive Ventilation

This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.

Start: August 2019

High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure

Oxygen therapy is first-line treatment in the management of acute respiratory failure (ARF). Different oxygen devices have become available over recent decades, such as low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) and high-flow systems (Venturi mask) . Since the 90's, non-invasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patient-ventilator asynchrony and even to intubation . High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters\ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% . It is a new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is because, even though NIV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same effect as NIV while being easier tolerated, more physiological , allowing patients to continue to talk, eat and drink through mouth while on HFNC

Start: May 2019

RIB PAIN (Rib Fractures Treated With Parental Analgesia With Infused LidocaiNe)

Traumatic rib fractures (RF) are a relatively common occurrence in patients of all ages, with a 10% incidence in all trauma patients and are associated with significant morbidity and mortality. Adequate analgesia is paramount for preventing pulmonary complications and can reduce morbidity and mortality. There is longstanding evidence of lidocaine's effectiveness and safety in the post-operative patient and the investigators hypothesize that this modality may prove to be ideal in trauma patients with RF. Therefore, it is imperative that intravenous lidocaine be investigated to ascertain if there is significant benefit for pain reduction in patients who have sustained rib fractures. A single-centre, double-blind, randomized control trial to evaluate the analgesic efficacy of a 72-96 hour IV lidocaine infusion plus standard analgesics versus placebo infusion plus standard analgesics will be performed on patients (age 18 or older) diagnosed with two or more traumatic rib fractures ,from blunt thoracic trauma, requiring hospital admission at Victoria Hospital. The primary outcome is mean pain score, as measured on the Visual Analog Scale (VAS) when the patient is at rest and with movement. Secondary outcomes are protocol adherence, patient satisfaction as measured on the VAS, incidence of respiratory failure requiring mechanical ventilation, hospital length of stay, ICU length of stay, mortality, incidence of lidocaine toxicity, treatment regimens (use of additional non-opioid analgesics) and total morphine equivalents used (including breakthrough doses). This trial will serve to quantify the analgesic efficacy of intravenous lidocaine for patients with traumatic rib fractures. Successful completion of a single centre trial will inform the development of a multi-centre trial powered to demonstrate a reduction in respiratory failure in the trauma population.

Start: June 2019

Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

The Acute Respiratory Distress Syndrome (ARDS) impacts one of every four patients requiring mechanical ventilation for respiratory support and carries a mortality rate of 40%. To diagnose ARDS, doctors currently use the Berlin definition, that requires chest radiographs and analysis of oxygenation in the blood (arterial blood gas). These tests are not available in areas of the world with constrained resources and may be unnecessarily invasive. A modification of the Berlin definition, using ultrasound and pulse oximetry (a small device that measures oxygen level non-invasively by clipping to the body, typically a finger), has been recently developed and tested in Kigali, Rwanda. This study will try to confirm the validity of the Kigali modification initially in Boston and Toronto and subsequently in other hospitals worldwide. If confirmed, this new definition could allow for faster recognition and potentially improved treatment of patients with ARDS and facilitate studies worldwide. The purposes of this study are: To describe clinical characteristics and outcomes of patients diagnosed with ARDS according to the Berlin and Kigali definitions; To determine how well chest radiograph and ultrasound of the chest are able to define ARDS, in comparison to chest computer tomography (CT).

Start: October 2018

Inert Gas Rebreathing in Ventilated Patients

Measuring hemodynamic parameters in ventilated patients is important yet still complicated to perform. Inert gas rebreathing (IGR) showed promising results when being compared to other invasive as well as non-invasive techniques for the measurement of cardiac output. The aim of our study is to evaluate the feasibility of IGR in ventilated patients.

Start: March 2013

Rapid Atrial Fibrillation Treatment Strategy

Prospective, randomized, open-label clinical trial studying the treatment of new onset atrial fibrillation in critically ill patients with septic shock. Patients will be assigned to rhythm vs rate control strategies with various outcome measures assessed.

Start: September 2019

Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure

Background An appropriated mechanical ventilator setting for acute respiratory failure results of ventilator associated lung injury. Limited driving pressure and low tidal volume ventilation strategies show benefits decreasing mortality in acute respiratory distress syndrome, but there are no data in simple acute respiratory failure.

Start: July 2019

Targeted OXYgen Therapy in Critical Illness

The investigators propose to conduct a feasibility, multi-centre, randomised controlled trial of targeted oxygen therapy in adult critically ill patients receiving mechanical ventilation via an endotracheal tube as part of their treatment for respiratory failure. Participants will be allocated to either a normal blood oxygen target group or a lower than normal blood oxygen target group. The primary purpose of the study will be to assess the feasibility of recruiting complex patients who lack capacity into a clinical trial in which oxygenation is being assessed, and that the clinicians responsible for these patients are able to deliver the intervention effectively. The safety of using a lower than normal blood oxygen target will also be assessed and blood samples taken for subsequent investigation of the biological mechanisms underlying the observed changes. Participants will be randomised (1:1) into either an intervention or control group. The intervention in this trial is tightly controlled administration of oxygen to patients to achieve a haemoglobin oxygen saturation (SpO2) of 88-92%. The control group will also have tightly controlled oxygen administration, but to achieve an SpO2 of 96% or above. The target for the control group represents a normal SpO2, whilst that in the intervention group is lower than what is considered to be normal. It should be noted that although lower than normal, this SpO2 is close to what the general public experience when travelling by pressurised aircraft as the fractional inspired oxygen concentration in that situation is only 0.15-0.17 (15-17%). The controlled oxygen administration would commence as soon as possible after admission to the critical care unit and end following removal of the participant's artificial breathing tube. The researchers and clinical team cannot be blinded to treatment allocation, due to the nature of the intervention. Those analysing the data will be blinded to the intervention.

Start: January 2018

The Relationship Between Trans-diaphragmatic Pressure and Diaphragmatic Contraction

Through this study the investigators aim to clarify the relationship between trans-diaphragmatic pressure and various parameters of the diaphragmatic contraction evaluated by ultrasound. The following parameters will be studied: esophageal pressure, gastric pressure, diaphragm thickness at peak inspiration (Tdi,pi), diaphragm thickness at end expiration (Tdi,ee), diaphragm thickening (Tdi,pi - Tdi,ee), diaphragm thickness fraction [TFdi=(Tdi,pi - Tdi,ee)/Tdi,ee], diaphragm excursion (Di,e), Maximal Inspiratory pressure (M.I.P), Pressure-Time product of the trans-diaphragmatic pressure (P?Pdi),Tension Time Diaphragm Index (T.T.Di) and the rapid shallow breathing index (R.S.B.I.). These measurements will be made in two phases.Firstly, during the spontaneous breathing trial and secondly during spontaneous breathing through an airway of reduced diameter.Furthermore, during the M.I.P. test the aforementioned ultrasound parameters will be measured. The aim of this study is to discover new means of a successful prediction of weaning in the first 48 hours following extubation.

Start: June 2018