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Ventilator Weaning clinical trials

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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: NCT04711759 Completed - Ventilator Weaning Clinical Trials

Physiologic Effects of High-flow Nasal Cannula Versus Standard Oxygen Therapy Postextubation in Critically Ill Patients

Start date: January 27, 2021
Phase: N/A
Study type: Interventional

High-flow nasal cannula (HFNC) is a rather novel system to provide oxygen therapy, which provides flows up to 60 liters/minute (LPM) of heated and humidified gas through nasal prongs. HFNC is increasingly being used in patients with acute respiratory failure. In healthy volunteers and in patients with acute respiratory failure it has been shown to induce several effects beyond those expected for a standard oxygen therapy, such as increased carbon dioxide (CO2) clearance and positive airway pressure. One of the potential indications for HFNC is to facilitate weaning from mechanical ventilation and extubation. As weaning failure is one of the most complex challenges in mechanically ventilated patients, the use of HFNC after extubation, in order to prevent reintubation, has been evaluated in some clinical trials, with promising results. However, the role of HFNC postextubation is still controversial, and information regarding its effects on the pathophysiologic mechanisms of weaning failure is lacking. The goal of this proposal is to compare the acute physiologic effects of postextubation HFNC versus standard oxygen therapy, in critically ill patients, on relevant mechanisms related to weaning failure: work of breathing, lung function, systemic hemodynamics. This will be a randomized crossover study which will include critically ill mechanically ventilated patients, who fulfill criteria indicating they may be ready for weaning from mechanical ventilation, and in whom a spontaneous breathing trial (SBT) is planned to determine if they should be extubated. After checking eligibility and obtaining informed consent, patients will be monitored with an esophageal catheter (esophageal / gastric pressures to determine work of breathing, and electric activity of diaphragm to determine neuromechanical coupling), and a noninvasive ventilation monitor (electric impedance tomography to assess global and regional ventilation). Work of breathing, lung function, and systemic hemodynamics will be assessed during the SBT. Inclusion in the study will be confirmed only if they pass the SBT and are extubated. During the first 2 hours after extubation patients will undergo one hour of HFNC and one hour of standard oxygen therapy, with the crossover sequence being randomized previously at the time of inclusion, and with assessments repeated at the end of each treatment period.

NCT ID: NCT04204967 Completed - Clinical trials for Respiratory Insufficiency

Totally Transdermal Sedation in the Weaning From Remifentanil Infusion

TOES
Start date: February 15, 2021
Phase: Phase 2
Study type: Interventional

The choice of the sedation protocol has a massive impact on the duration of mechanical ventilation and the timing of extubation. Many sedation protocols are described in the literature. The investigators aim to assess if a transdermal fentanyl-based sedation protocol can have an impact on the global Work of Breathing (WOB)

NCT ID: NCT04011852 Completed - Child Clinical Trials

The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning

Start date: September 26, 2019
Phase:
Study type: Observational [Patient Registry]

To correlate the data obtained by Electrical impedance tomography (EIT) during the spontaneous breathing trials (SBT) on a T-piece, in children, with failure in the trial and Extubation failure. Observe if the EIT monitoring will be able to detect the children that will fail earlier than the SBT performed alone. Method: A cross-sectional, prospective study to explore the potential benefits of monitoring with EIT during weaning.

NCT ID: NCT03832231 Completed - Intensive Care Unit Clinical Trials

Use of Transient Elastogaphy to Assess Diaphragm Function in Mechanically Ventilated Patients

Elasto-ICU
Start date: February 14, 2019
Phase: N/A
Study type: Interventional

Mechanical ventilation is a life-saving treatment that can be associated with diaphragm dysfunction, a potentially deleterious acquired disability. It may be the consequence of disuse - under mechanical ventilation, respiratory muscles are unloaded - or the consequence of muscle overuse because of insufficient unloading. Evaluating diaphragm function is therefore crucial to optimally tailor the ventilator assistance. Measurement of transdiaphragmatic pressure (Pdi) is the reference method to assess diaphragm function but it invasiveness hinders the generalization of its use. Previous studies have reported that ultrasound can quantify diaphragm thickening and that diaphragm thickening fraction (TFdi) is a good marker of diaphragm function. Since diaphragm becomes stiffer when it contracts, the investigators aim at exploring whether the measurement of diaphragm stiffness by transient shear wave elastography would improve the evaluation of diaphragm function with ultrasound. Therefore, the objectives of the study are to evaluate the performance of transient shear wave elastography applied to the diaphragm to estimate Pdi in mechanically ventilated patients as compared to TFdi and to correlate the changes in elastography derived indices, in TFdi and in Pdi into different ventilatory conditions and during a spontaneous breathing trial. Pdi will be obtained using catheters positioned in patients' stomachs and esophagus and diaphragm stiffness will be assessed by measuring the shear modulus of the diaphragm with a dedicated ultrasound machine (Aixplorer, Ultrasonic). TFdi will be also measured as previously reported. Pdi, TFdi and shear modulus will be measured at the end of each four following 10 minutes-conditions: 1) baseline with initial ventilator settings (set by the physician in charge of patient); 2) 25%-increase in pressure support and initial PEEP; 3) 25%-decrease in pressure support and initial PEEP and 4) initial level of pressure support and ZEEP. Finally, the same measurements will be done at the beginning of a 30 minutes spontaneous breathing trial.

NCT ID: NCT03795623 Completed - Brain Injuries Clinical Trials

Voices of Patients' Relatives to Support Weaning From Mechanical Ventilation

VOICE-WEANING
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Patients with severe brain injuries, such as ischemic stroke and intracranial hemorrhage, frequently require mechanical ventilation. Weaning of stroke patients is complicated by impaired consciousness and respiratory drive. Higher rates of weaning failure and delayed extubation (≥ 48h) lead to ventilator associated pneumonia, higher mortality and necessity of tracheostomy. Therefore, improving the weaning of stroke patients from mechanical ventilation is warranted to prevent ventilator-associated complications and eventually improve clinical outcomes. This single-center, randomized, clinical trial aims at demonstrating that voices of patients' relatives support weaning from mechanical ventilation and reduce weaning failure in brain-injured patients.

NCT ID: NCT03673683 Completed - Ventilator Weaning Clinical Trials

Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation

SANDWICH
Start date: February 5, 2018
Phase: N/A
Study type: Interventional

A UK multi-centre cluster randomised controlled trial to determine if a protocol-based intervention incorporating coordinated care with greater nursing involvement to managing sedation and ventilator weaning can reduce the duration of invasive mechanical ventilation and is cost effective compared with usual care in children in Pediatric Intensive Care Units.

NCT ID: NCT03486249 Completed - Ventilator Weaning Clinical Trials

Interaction Diaphragm and Cardiac Function During Ventilator Weaning

I-DISCO
Start date: April 27, 2018
Phase: N/A
Study type: Interventional

Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. While diaphragm dysfunction and pulmonary edema are two main causes of weaning failure, there are currently no data that quantify their respective contribution neither their potential co-existence. During weaning from mechanical ventilation, heart and lung interaction plays a major role. As a key factor, diaphragm function is therefore certainly involved in the occurrence of weaning-induced pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced pulmonary edema have not been simultaneously investigated so far. This current project aims at exploring the relationship between diaphragm dysfunction and pulmonary in patients experiencing weaning failure. The objectives are 1) to quantify the respective contribution and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to investigate the role of diaphragm function in the occurrence of weaning induced pulmonary edema.

NCT ID: NCT03433105 Completed - Ventilator Weaning Clinical Trials

Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation

Start date: January 23, 2018
Phase:
Study type: Observational

1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the work load caused by weaning was below the patient's AT, oxygen uptake will be constant. Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase. 1. Patient: who have tracheostomy tubes and with prolonged mechanical ventilation 2. Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous breathing trials 3. Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome 2.Specific aims: 1. to investigate the prognostic value of oxygen uptake in weaning patients from prolonged mechanical ventilation 2. Subgroup analysis may suggest which weaning protocol potentially benefit the most for each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular disease, cerebrovascular disease)

NCT ID: NCT03357198 Completed - Clinical trials for Respiratory Insufficiency

Correlation of Two Methods for Cough Peak Flow Measurement in Intubated Patients

COUGH-ICU
Start date: December 8, 2017
Phase:
Study type: Observational

Cough Peak Flow (CPF) seems to be an efficient tool to assess cough capacity for the intensive care unit (ICU) ventilated patient. CPF can be used in the ventilator weaning process, as reflecting the upper airways protection capacity. CPF requires disconnection of the patient from the ICU ventilator, supplemental material (handheld spirometer, antibacterial filter) and an excellent synchronization between the specialized caregiver and the patient. We aimed that CPF with the ventilator built-in flow-meter is correlated with CPF using a handheld flowmeter connected to the endotracheal tube.