Treatment Trials

16 Clinical Trials for Various Conditions

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COMPLETED
EIT Assessment of Lung Volume and Tidal Distribution: A Comparison of Non-Invasive Ventilation Devices
Description

This study is being done to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.

ACTIVE_NOT_RECRUITING
Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation
Description

The overall objective of the study is to conduct an observational study involving intensive care unit patients receiving mechanical ventilation and determine if there are differences in diaphragm thickness ultrasound measurements during expiratory and inspiratory phases in a controlled and spontaneous mode. For patients receiving sedatives, an additional set of measurements will be taken during a standard of care interruption of sedatives

TERMINATED
Synchronized Intermittent Mechanical Ventilation Versus Open Lung Ventilation With Spontaneous Respiration
Description

The purpose of this study is to collect data on patients who are on breathing machines (ventilators) in the Trauma Surgical Intensive Care Unit (TSICU). This data may help us to determine if one form of assisted breathing is better than another. The two forms of assisted breathing being compared in this study are called BiVent and SIMV. (7) BiVent and SIMV are both delivered by a ventilator but differ in how they assist breathing. SIMV is an older form of mechanical breathing that blows air into the lungs to inflate the lungs. BiVent is a newer form of mechanical ventilation that permits the patient to pull air into the lungs as we normally do. Both BiVent and SIMV are currently being used on a regular basis in the TSICU. The investigators hope that this study will determine if one method of assisted breathing is better than another in preventing complications associated with mechanically assisted breathing.

Conditions
RECRUITING
Optimal Timing for Spontaneous Breathing Trials
Description

This study aims to explore how the timing of Spontaneous Breathing Trials (SBTs) affects recovery in adult patients who are on mechanical ventilation in the ICU. SBTs are tests used to determine if a patient is ready to breathe on their own without the help of a ventilator. The study will compare two different timing strategies for these trials: one group of patients will have the test early in the morning, while the other group will have it later in the morning. By observing the outcomes, such as how long patients need to stay on the ventilator, the study hopes to find the best time to perform these trials to help patients recover more quickly and safely.

TERMINATED
Feasibility of Music Therapy for Spontaneous Breathing Trials
Description

In this study, the investigators will study music therapy for patients during breathing trials, a procedure performed in intensive care units. Participants will be assigned either to standard medical care or standard medical care plus music therapy. Participants have a 50/50 chance (like flipping a coin) of being in either group. In the music therapy group, a board-certified music therapist will sing softly with guitar accompaniment to provide music during the breathing trial. The music is in addition to the usual treatment provided by hospital staff. Participants in the standard medical care group will receive the usual medical care given by hospital staff members. Information will be collected from participant's charts and by observation of vital signs during the breathing trial.

COMPLETED
Mechanical Ventilation Discontinuation Practices
Description

Background: The requirement for ventilator support is a defining feature of critical illness. Weaning is the process during which the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the total time spent on ventilators is dedicated to weaning. The extent of practice variation in how this complex and expensive technology is discontinued from critically ill patients is unknown. Meanwhile, practice variation has been shown to adversely impact upon patient safety and clinical outcomes. Purpose: To characterize practice pattern variation in weaning and the consequences of weaning variation by implementing an international, prospective observational study in Canada, the United States, the United Kingdom, Europe, India and Australia/New Zealand. Primary Objectives: To describe 1. weaning practice variation among regions in 5 domains (the use of daily screening, preferred methods of support used before initial discontinuation attempts, use of written protocols, preferred methods of evaluating spontaneous breathing, and sedation and mobilization practices). 2. the assocation between selected discontinuation strategies and important clinical outcomes (length of stay, mortality, duration of ventilation). Methods: The investigators propose to conduct a large scale, observational study involving critically ill adults requiring ventilator support for at least 24 hours to evaluate practices in discontinuing ventilators in 150 centres. The investigators will classify each new admission over the observation period according to the initial strategy that precipitated or facilitated ventilator discontinuation. Relevance: This novel study will build collaborations with critical care investigators from around the world and industry

COMPLETED
A Study of the Effect of Arterial Carbon Dioxide Tension on the Recovery of Spontaneous Respiration
Description

The investigators data reveal an important new observation regarding the recovery of breathing during emergence from general anesthesia: respiration resumes as a prolonged abdominal expiration event. The present study aims to further clarify the physiology of recovery of breathing with the addition of a cutaneous monitor for arterial carbon dioxide measurement and a comparison of two different recovery paradigms.

COMPLETED
Weaning From Prolonged Mechanical Ventilation
Description

Patients requiring the use of artificial ventilation (also called mechanical ventilation) for more than 21 days account for more than 37% of all ICU costs. As such, these patients are now transferred to centers that specialize in weaning patients from the respirator; these units are referred to as long-term acute care (LTAC) facilities. Despite the increase of LTAC facilities, research on the fastest method for disconnecting the patient from the respirator is lacking. In addition, little information is available regarding the long-term survival and quality of life after a prolonged course of artificial ventilation. The purpose of this study is to determine the fastest method for disconnecting the patient from the respirator at a LTAC facility and its effect on long-term survival and quality of life.

WITHDRAWN
Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients
Description

This study will compare Drager Smart Care (SC), a commercially available automated ventilator controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning protocol. The study is designed to determine if automated ventilator controlled weaning can reduce total duration of intubation following mechanical ventilation in ICU patients requiring prolonged mechanical ventilation (\>72 hours).

COMPLETED
Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
Description

To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for detecting patients no longer needing mechanical ventilation.

TERMINATED
Sedation Versus No Sedation in a Spontaneous Breathing Trial
Description

An important part of how we decide when a patient is ready to have their breathing tube removed is to have a person breathe without any machine breaths while the breathing tube is still in place. We call this a spontaneous breathing trial. Commonly, while patients have the breathing tube, they are given medications to keep them sedated and comfortable so breathing does not bother them. These medicines are often stopped before the spontaneous breathing trial so they can be more awake for the test. There are signs the doctors look for during the spontaneous breathing trial that suggest the patient might not be ready for the breathing trial to come out. Signs like fast breathing, small breaths, a fast heart rate, or looking more anxious than usual may mean that the patient is not ready to come off the ventilator. However, if someone has been given sedation medicines the entire time they have had a breathing tube and are then woken up, they may naturally get very anxious. They may show the same signs as someone who is failing their breathing test, but in their case these signs are only because they are anxious.Doctors may mistake these signs as failing the breathing test and may not pull the breathing tube out even though the patient is really ready for it to come out. We wish to try and find out if patients do better during their spontaneous breathing trials if they are continued on some sedative medicines to treat anxiety or if they do better if the medicines are stopped before the test.

COMPLETED
The Effects of Ketamine on Respiratory Stimulation and Transpulmonary Pressures
Description

Impairment of airway patency is a common cause of extubation failure and opioids and hypnotics can adversely affect airway patency. Ketamine, a noncompetitive antagonist of N-methyl-D-aspartate (NMDA), unlike other anesthetics activates respiratory effort and promotes bronchodilation. At subanesthetic plasma concentration, ketamine reduces both opioid and propofol requirements. The purpose of this pharmaco-physiological interaction trial is to evaluate the effects of ketamine on breathing and electroencephalography in mechanically ventilated patients.

RECRUITING
Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH)
Description

The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.

UNKNOWN
The Frequency of Screening and SBT Technique Trial: The FAST Trial
Description

Background: The sickest patients who are admitted to an intensive care unit (ICU) often require assistance with their breathing. When patients start to get better, they gradually do more of the breathing and the machine does less-this is called weaning. Although ventilator use saves lives, the longer it is used, the more complications can occur. Clinicians aim to wean patients from ventilators in a timely and safe manner. In most ICUs, patients are screened (looked at) once per day to see if they are ready to undergo a weaning test (using a variety of techniques) to see if the breathing tube can be removed. Screening more than once per day may allow more weaning tests to be conducted. Knowing the best way to do a weaning test is important because some methods may better determine who can have the breathing tube removed safely. At present, we don't know the best way to help our sickest patients to wean from ventilators. Patients: Adults in North American ICUs who are on ventilators for at least 24 hours and who can take breaths on their own. Interventions: Patients in our study will receive one type of screening and one type of weaning test at random. In the 'once daily' screening groups, clinicians will screen patients each morning. In the 'two or more times daily screening' groups, patients will be screened in the morning, afternoon, and whenever else clinicians wish to screen. When screening criteria are met, patients will undergo one of two weaning tests with low ventilator support or no support. Outcomes: The main outcome of this study will be the time for patients to be successfully removed from the ventilator. Relevance: For patients, this study will clarify the best way to remove them from ventilators in a timely and safe manner. For clinicians and our health care systems, this study holds promise to improve how critically ill patients are weaned from breathing machines.

Conditions
UNKNOWN
Frequency of Screening and SBT Technique Trial
Description

The requirement for invasive mechanical ventilation is a defining feature of critical illness. Liberation or weaning is the process during which the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the time spent on mechanical ventilation is dedicated to weaning. Limiting the duration of invasive ventilation has been identified as a key research priority in critical care. Studies support the use of screening protocols (once daily vs. usual care) to identify weaning candidates and the conduct of tests of patient's ability to breathe spontaneously (SBTs). While once daily screening is the current standard of care in national intensive care units (ICUs), it is poorly aligned with the 24/7 ICU care environment wherein a critically ill patients' status can change from hour to hour. Only one large trial has compared alternative SBT techniques \[T-piece vs PS (Pressure Support)\]. No trial has compared a strategy of more frequent screening to once daily screening or alternative SBT techniques. The presence of respiratory therapists (RTs) 24/7 in North American ICUs presents a unique opportunity to screen more frequently, conduct more frequent SBTs, and determine the optimal strategy to liberate critically ill adults from invasive ventilation. The investigators propose to conduct a pilot randomized trial in 100 critically ill adults comparing 'once daily' screening to 'at least twice daily' screening and PS vs. T-piece SBTs in 12 Canadian ICUs. In the proposed trial, the investigators will (i) assess their ability to recruit critically ill adults who can breathe spontaneously or initiate breaths on one of several commonly used modes of ventilation into the trial, (ii) evaluate clinician's ability to implement the trial as designed, (iii) assess current practices in sedation, analgesia and delirium management and timing of patient mobilization prior to conducting screening assessments, (iv) identify barriers (clinician, institutional) to enrolling patients, (v) characterize trial participants based on weaning difficulty, and (vi) obtain preliminary estimates of the impact of the alternative screening and SBT strategies on clinically important outcomes.

Conditions
WITHDRAWN
Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients
Description

This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous breathing. The second is to determine if heart rate variability, (HRV) a reflection of autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can predict patient outcomes including successful weaning and in-hospital recovery time after an episode of cardiopulmonary compromise requiring MV. Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF, respiratory rate, and blood pressure; Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation awakening (a period immediately prior to SBT when sedative medications are discontinued) will be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths of stay; more abnormal measurements will be associated with longer lengths of stay; Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.