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Pulmonary Valve Insufficiency clinical trials

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NCT ID: NCT02989051 Recruiting - Critical Illness Clinical Trials

Fluid Restriction Keeps Children Dry

LESSER
Start date: September 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: Fluid overload is a common complication in children who are admitted to the pediatric intensive care for mechanical ventilation. Acute lung infection is a frequent cause for admission to the PICU and forms an uniform group with a single organ failure. In these critically ill children, fluid overload is associated with adverse outcome. Restricting the volume of fluids already in an early stage of ICU admission may prevent fluid overload during mechanical ventilation and thus improve clinical outcome. However, at the same time fluid restriction may interfere with appropriate energy and macronutrient intake that is needed for recovery. Objective: The main goal of this pilot study is to evaluate the feasibility of a restrictive fluid management protocol and investigate its effect on the occurrence of fluid overload in mechanically ventilated children with acute infectious lung disease. Study design: Single-center prospective randomized feasibility and pilot study in preparation of a multi-center randomized controlled trial (RCT). Study population: Mechanically ventilated children with (suspicion of) acute infectious lung disease admitted to the pediatric intensive care unit (PICU) of the Emma Children's Hospital, Academic Medical Center, Amsterdam. Intervention: Patients receive either liberal (control group) or a restrictive (experimental group) fluid treatment, while ensuring appropriate caloric intake. Main study parameters/endpoints: Primary outcomes are cumulative fluid balance and body weight during the first week of mechanical ventilation. Secondary outcomes (in preparation of the larger multi-center RCT) include: mortality, duration of mechanical ventilation and oxygenation indices. To determine the feasibility, in- and exclusion rate, adherence to treatment arms, need for fluid bolus, need for diuretics and hemodynamic indices as well as energy and protein intake are studied. Both fluid management protocols reflect a variant of current clinical practice, hence will not provide extra burden or risk to patients included in the study. Patients will be randomized to either of the fluid protocol arms on admission to the PICU (at start of mechanical ventilation). Patients included in the restrictive fluid treatment arm might have direct benefit from the study if indeed fluid overload is less common in this group.

NCT ID: NCT02987387 Active, not recruiting - Clinical trials for Cardiovascular Diseases

COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

Start date: July 17, 2017
Phase:
Study type: Observational

This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.

NCT ID: NCT02983825 Completed - Clinical trials for Infant, Premature, Diseases

Impact of CPAP Level on V/Q Mismatch in Premature Infants

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do not match up with the areas of the lung that are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch to changes in the amount (or level) of CPAP.

NCT ID: NCT02979587 Active, not recruiting - Clinical trials for Congenital Heart Disease

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Start date: January 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

NCT ID: NCT02972021 Not yet recruiting - Clinical trials for Patients With Respiratory Insufficiency

High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients

Start date: December 2016
Phase: N/A
Study type: Interventional

Chronic respiratory insufficiency in patients with advanced disease to the late treatment depends mainly on mechanical ventilation and other high intensity respiratory support therapy. Strengthen the stability of chronic respiratory insufficiency intervention can reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of respiratory support therapy. There is little research on the role of HFNC in oxygen therapy for chronic respiratory insufficiency. Our previous studies have found the potential value of HFNC in chronic respiratory insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals in an effort to confirm that HFNC can improve the prognosis of patients with chronic respiratory insufficiency compared with nasal oxygen therapy.

NCT ID: NCT02942797 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

NRS 2002 as a Predictor of Prognosis in COPD With Respiratory Failure

Start date: April 1, 2017
Phase:
Study type: Observational

This is a prospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during April 2017 to March 2019. The following variables will be prospectively studied: age, sex, height, weight, respiratory function indicators, arterial blood gas analysis results, biochemical data, nutritional risk screening 2002 (NRS 2002) score, short-term and long-term prognostic outcomes. The purpose of this study is to assess whether NRS 2002 is a useful prognosis predictor in COPD patients with respiratory failure.

NCT ID: NCT02942784 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Comparison of Three Nutritional Assessment Methods Predicting Prognosis in COPD With Respiratory Failure

Start date: April 1, 2017
Phase:
Study type: Observational

This is a retrospective study of patients diagnosed with chronic obstructive pulmonary disease (COPD) with respiratory failure and admitted in West China Hospital during January 2014 to March 2016 by review of medical records. The following variables will be retrospectively studied: age, sex, marriage, height, weight, respiratory rate, PaO2, PaCO2, nutritional risk screening 2002 (NRS 2002) score, ALB, short-term and long-term prognostic outcomes, and so on. The purpose of this study is to compare the predictive power of three widely used nutritional assessment methods (BMI, NRS 2002 and ALB) predicting the prognostic outcomes in a cohort of COPD patients with respiratory failure.

NCT ID: NCT02939963 Completed - Clinical trials for Acute Respiratory Insufficiency

Ventilation Strategies During Spontaneous Breathing Trial

WEANING
Start date: August 23, 2017
Phase: N/A
Study type: Interventional

Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on. Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.

NCT ID: NCT02930525 Completed - Clinical trials for Respiratory Insufficiency

Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation

HiFiPPS
Start date: September 2016
Phase: N/A
Study type: Interventional

Procedural sedation is an established and safe intervention and is widely used in diagnostic and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory system such as upper airway obstruction, hypoventilation and apnea are frequent adverse events. We postulate that respiratory instability is less frequent in patients high flow nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper gastrointestinal endoscopy under pediatric procedural sedation (PPS).

NCT ID: NCT02929446 Completed - Clinical trials for Respiratory Insufficiency

Mobilization Immediate After Abdominal Surgery

Start date: December 2016
Phase: N/A
Study type: Interventional

Advances in surgical technique have led to a more complex surgery on patients with more serious comorbidities and the risk of postoperative pulmonary complications (PPC) is considerable . The isolated effect of mobilization immediately after surgery has previously not been studied. The aim of the study is to evaluate the effects of immediate mobilization (within 2 hours after arrival to the postoperative recovery unit) after abdominal surgery and also the patients and the staffs experiences of early mobilization. Methods: A randomized controlled trial will be conducted. A total of 300 Swedish-speaking, adult patients (≥18 years) planned for elective open or robot assisted laparascopic abdominal surgery with an expected anesthetic duration exceeding 2 hours are eligible for consecutive enrollment in the study. Patients who cannot mobilize independently before surgery, will be excluded. Procedure: Randomization to: 1. Mobilization within 2 hours after arrival to the postoperative recovery unit after surgery - to sit up as long as they can in a chair, or on the bedside + breathing exercises standardized every hour, with a PEP-device or to 2. Mobilization within 2 hours after arrival to the postoperative recovery unit after surgery - to sit up as long as they can in a chair, or on the bedside. or to 3. No mobilization - laying or sitting in bed with a maximum of 30° elevation of the head rest. No mobilization out of the bed or breathing exercises until discharge or a maximum of 6 hours. Outcome assessment: The primary outcomes are arterial oxygen pressure (PaO2), and peripheral oxygen saturation (SpO2) over time and between groups. Secondary outcomes are arterial carbon dioxide pressure (PaCO2), pH, bGlu, lactate (arterial blood gas sample) over time and between groups; lung function assessed as forced vital capacity (FVC), forced expiratory flow in the one second (FEV1) and peak expiratory flow (PEF) by a micro spirometer ( preoperatively and the day after surgery); postoperative pneumonia and total length of stay at the postoperative recovery unit and at the hospital. After the intervention both patients (n 25) and staff (n 20) will be interviewed about experiences of early mobilization. Clinical significance: If a fairly simple and cheap intervention, such as mobilization immediately after open abdominal surgery, can lead to imporved oxygen saturation, shortened stay at hospital in total, it should be included as a routine in postoperative care.