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NCT ID: NCT05380687 Recruiting - Respiratory Failure Clinical Trials

Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training

TONES
Start date: June 15, 2022
Phase: N/A
Study type: Interventional

The TONES trial aims to evaluate the neuroventilatory efficiency (NVE = tidal volume / peak voltage of diaphragm contraction) measured during a zero-assist manoeuvre (ZAM, i.e. with PEEP but without pressure support). This novel parameter, NVE-ZAM, will be studied in a blocked, crossover, repeated measures design. Possible confounders, such as activity of respiratory muscles other than the diaphragm, are included. The investigators hypothesized that - the NVE during a zero-assist maneuver has a low variability and high repeatability at the same level of PEEP (within subjects, within blocks) - NVE-ZAM trends differ between participants (between subjects, within blocks) and between PEEP levels (within subjects, between blocks) The primary aim is to study the variability and repeatability of the NVE-ZAM within subjects and within blocks. Additionally, the effect of PEEP, muscle fatigue and recruitment of the accessory and expiratory muscles of respiration on the NVE-ZAM will be studied in an exploratory analysis (in multiple combinations of within and between subjects and/or blocks).

NCT ID: NCT05261607 Recruiting - Respiratory Failure Clinical Trials

Analysis of the Evolution of Mortality in an Intensive Care Unit

Start date: July 1, 1991
Phase:
Study type: Observational

The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment. Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU. Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients. That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit. Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026

NCT ID: NCT05254691 Completed - Respiratory Failure Clinical Trials

WOB and Paediatric Mechanical Ventilation

PedWOB
Start date: November 29, 2017
Phase: N/A
Study type: Interventional

Rationale: The most common approach to weaning infants and children is gradual reduction of ventilatory support ("traditional approach"). Alternatively, another approach to weaning is attempted with alternating periods of complete ventilatory support and graded spontaneous breathing with assistance ("sprinting approach"). Both approaches are used randomly in our unit: the decision to use which approach is dependent upon the preferences of the attending physician as described in many observational single center studies. To date, there is no data comparing the safety and efficacy of the "sprinting" approach with more traditional approaches of weaning in children. Hence, numerous issues remain unanswered, including the work-of-breathing during each approach. For this research proposal, we want to measure the work-of-breathing daily, using the traditional approach (the area under the oesophageal pressure - volume curve) and study its correlation with clinical parameters and EMG activity of the diaphragm and intercostal muscles from the moment that the patient is weaned off the ventilator. Objective: The primary objective for this study is to compare for each patient of the work-of-breathing during the "sprinting"approach and the "traditional approach.The secondary objectives for this study are to compare the oesophageal pressure rate and (PRP) and pressure time product (PTP), the PaO2/FiO2 ratio, global and regional distribution of tidal volume measured using electrical impedance tomography (EIT), phase distribution of the respiratory inductive plethysmography (RIP) signal and the EMG activity of the diaphragm and intercostal muscles between the "sprinting"and the "traditional" approach.. Study design: This is a prospective exploratory study with invasive measurements in a 20 bed tertiary paediatric intensive care facility at the Beatrix Children's Hospital/University Medical Centre Groningen. Study population: All mechanically ventilated children aged 0 to 5 years with or without lung pathology admitted to the paediatric intensive care unit are eligible for inclusion. Inclusion criteria include mechanical ventilation for at least 48 hours, weight ≥ 3 kg, sufficient respiratory drive present, deemed eligible for weaning by the attending physician, and stable haemodynamics (defined by the absence of need for increase in vaso-active drugs and/or fluid challenges at least 6 hours prior to enrolment). Exclusion criteria include mechanical ventilation less than 48 hours, not eligible for weaning (usually when there are unstable ventilator settings, defined by the need for increase of inspiratory pressures or positive end-expiratory pressure, and a FiO2 > 0.6 within 6 hours prior to enrolment), unstable haemodynamics (defined by the need for increase in vaso-ative drugs and/or fluid challenges within 6 hours prior to enrolment), leakage around the endotracheal tube > 5%, admitted to the neonatal intensive care unit, preterm birth with gestational age corrected for post-conceptional age less than 40 weeks, congenital or acquired neuromuscular disorders, congenital or acquired central nervous system disorders with depressed respiratory drive, congenital or acquired damage to the phrenic nerve, congenital or acquired paralysis of the diaphragm, use of neuromuscular blockade prior to enrolment, uncorrected congenital heart disorder, and chronic lung disease. Main study parameters/endpoints: The main study parameter is the level and time course of the patient's work-of-breathing mathematically calculated by the area under the pressure-volume curve Secondary study parameters include the level and time course of the PRP and PTP, level and time course of oxygenation (PaO2/FiO2 ratio), global and regional distribution of tidal volume, phase distribution, EMG activity of the diaphragm and intercostal muscles, heart rate, respiratory rate.. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are a priori no specific benefits for the patients who participate in the study.

NCT ID: NCT05141396 Recruiting - Clinical trials for Respiration, Artificial

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

TEACH
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05049200 Completed - COVID-19 Clinical Trials

Characteristics of Weaning From Mechanical Ventilation in COVID-19

CovWean
Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

This report is a multicenter, observational, analytical and prospective study. The objective was to describe the weaning of mechanical ventilation in patients with SARS-CoV-2 and the clinical results according to the different types of weaning.

NCT ID: NCT05035355 Recruiting - Clinical trials for Respiration, Artificial

A SBT-based Protocol-directed Program in Difficult-to-Wean Patients

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. The investigators aimed to determine whether spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula (HFNC) could be superior to routine SBT-based weaning in reducing the duration of mechanical ventilation (MV) in difficult-to-wean patients.

NCT ID: NCT04939285 Recruiting - Clinical trials for Respiration, Artificial

Effect of PEEP=5cmH2O vs PEEP=0cmH2O PSV Strategies During SBT on Successful Disconnection From Mechanical Ventilation

PPSDMV-RCT
Start date: June 10, 2020
Phase: N/A
Study type: Interventional

Mechanical ventilation is the most common means of life support in intensive care unit. Daily spontaneous breathing trial (SBT) is the most effective method to evaluate whether patients on mechanical ventilation can be removed from the ventilator, thus reducing mechanical ventilation duration and ventilator-related complications. Pressure support ventilation and T-piece ventilation are the two most commonly used SBT methods, lasting from 30 minutes to 2 hours. However, the parameter setting for SBT using PSV method has not been completely agreed, especially regarding the use of positive end-expiratory pressure (PEEP). Therefore, we intend to conduct a single-center, prospective, randomized, controlled study to evaluate the impact of PEEP=0cmH2O and PEEP=5cmH2O on extubation success rate and re-intubation rate in mechanically ventilated patients, to provide high-level clinical evidence on the use of PEEP for SBT in patients with mechanical ventilation, so as to reduce the duration of mechanical ventilation and complications related to mechanical ventilation.

NCT ID: NCT04894214 Completed - Clinical trials for Respiration, Artificial

Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19

VICAR
Start date: January 11, 2021
Phase:
Study type: Observational

Flow controlled ventilation (FCV) is a fairly new mode of mechanical ventilation, consisting of a constant inspiratory and expiratory flow. Inspiration is thus comparable to volume controlled ventilation (VCV). The actively controlled, constant flow during expiration is unique. FCV is known to minimize dissipated energy to the lung [ref] and is therefore supposed to aid in lung protective ventilation. The VICAR study is designed as a prospective single cohort crossover trial. The intervention consists of a sequence of respiratory modes: baseline pressure controlled ventilation (PCV) during 5 minutes, followed by 30 minutes of FCV with an evone respirator (Ventinova Medical B.V., Eindhoven, The Netherlands) and eventually 30 minutes of VCV. Every participant will receive the intervention. Respiratory rate (RR), positive end-expiratory pressure (PEEP) and inspiratory fraction of oxygen (FiO2) will be held constant. According to the manufacturers guidelines, an I:E ratio of 1:1 will be pursued during FCV. During FCV, the respirator will be set with the same PIP as during baseline PCV. For VCV, the same tidal volume as during baseline PCV will be set.

NCT ID: NCT04819165 Completed - COVID-19 Clinical Trials

Healthcare-associated Infections in Severe COVID-19 During 2020

COVIACS
Start date: March 1, 2020
Phase:
Study type: Observational

In patients who develop ARDS due to SARS-CoV-2 (CARDS), a longer duration of invasive mechanical ventilation (IMV) and ICU stay has been reported compared to ARDS not associated with SARS-CoV-2. Consequently, the days of stay in ICU increase Identifying the risk factors associated with the development of this complication and developing measures aimed at its prevention could have a favorable impact on the clinical course of seriously ill patients.

NCT ID: NCT04652401 Completed - Quality of Life Clinical Trials

Quality of Life in Ventilator-dependant Neuromuscular Patients

EqualVENT
Start date: December 2, 2020
Phase:
Study type: Observational

This study aims at evaluating the quality of life of patients with slowly progressive neuromuscular disorders who are dependant on mechanical ventilation (daily usage ≥ 16h).