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Ventilator-Induced Lung Injury clinical trials

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NCT ID: NCT01962818 Completed - Clinical trials for Bronchopulmonary Dysplasia

High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance.

Start date: January 2014
Phase: N/A
Study type: Interventional

Background Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending pressure and therefore small tidal volume. Animal studies showed that recruitment and maintenance of functional residual capacity (FRC) during HFOV ("open lung concept") could reduce lung injury. "Open lung HFOV" is achieved by delivering a moderate high mean airway pressure (MAP) using oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung recruitment. Electric Impedance Tomography (EIT) enables measurement and mapping of regional ventilation distribution and end-expiratory lung volume (EELV). EIT generates cross-sectional images of the subject based on measurement of surface electrical potentials resulting from an excitation with small electrical currents and has been shown to be a valid and safe tool in neonates. Purpose, aims: - To compare HFOV-sigh with HFOV-only and determine if there is a difference in global and regional EELV (primary endpoints) and spatial distribution of ventilation measured by EIT - To provide information on feasibility and treatment effect of HFOV-sigh to assist planning larger studies. We hypothesize that EELV during HFOV-sigh is higher, and that regional ventilation distribution is more homogenous. Methods: Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4 alternating 1-hours periods (2-treatment, double crossover design, each patient being its own control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV will remain at pretrial settings. 16 ECG-electrodes for EIT recording will be placed around the chest at study start. Each recording will last 180s, and will be done at baseline and at 30 and 50 minutes after each change in ventilator modus. Feasibility No information of EIT-measured EELV in babies on HFOV-sigh exists. This study is a pilot-trial. In a similar study-protocol of lung recruitment during HFOV-sigh using "a/A-ratio" as outcome, 16 patients was estimated to be sufficient to show an improvement by 25%. This assumption was based on clinical experience in a unit using HFOV-sigh routinely. As the present study examines the same intervention we assume that N=16 patients will be a sufficient sample size. We estimate to include this number in 6 months.

NCT ID: NCT01959009 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Blood Oxygenation and Stability of Oxygenation

Start date: August 2014
Phase: N/A
Study type: Interventional

Background: Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending pressure and therefore small tidal volume. Animal studies showed that recruitment and maintenance of functional residual capacity (FRC) during HFOV ("open lung concept") could reduce lung injury. "Open lung HFOV" is achieved by delivering a moderate high mean airway pressure (MAP) using oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung recruitment. This has however to our knowledge not been tested in a clinical trial using modern ventilators. Purpose, aims: - To compare HFOV-sigh with HFOV-only and determine if there is a difference in oxygenation expressed as a/A-ratio and/or stability of oxygenation expressed as percentage time with oxygen saturation outside the reference range. - To provide information on feasibility and treatment effect of HFOV-sigh to assist planning larger studies. We hypothesize that oxygenation is better during HFOV-sigh. Methods: Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4 alternating 1-hours periods (2-treatment, double crossover design, each patient being its own control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV will remain at pretrial settings. Outcome will be calculated from normal clinical parameters including pulx-oximetry and transcutaneous monitoring of oxygen and carbon-dioxide partial pressures.

NCT ID: NCT01601223 Completed - Surgery Clinical Trials

Local Assessment of Ventilatory Management During General Anesthesia for Surgery

LAS VEGAS
Start date: January 2013
Phase: N/A
Study type: Observational

Objectives 1. To characterize mechanical ventilation practices during general anesthesia for surgery 2. To assess the dependence of intra-operative and post-operative pulmonary complications on intra-operative Mechanical Ventilation (MV) settings

NCT ID: NCT01522599 Terminated - Clinical trials for Acute Respiratory Distress Syndrome

Flow-flow ECCO2-R and 4 ml/kg Tidal Volume vs. 6 ml/kg Tidal Volume to Enhance Protection From VILI in Acute Lung Injury

ELP
Start date: April 2012
Phase: Phase 3
Study type: Interventional

The main objective of this randomized multicenter clinical trial is to test the hypothesis that further reduction of VT to 4mL/kg may enhance lung protection in patients with ARDS as compared to the conventional "ARDS-Net" ventilation. Control of PaCO2 in the ~4 ml/kg arm would be accomplished by LFPPV- ECCO2-R.

NCT ID: NCT01514331 Completed - Clinical trials for Ventilator Induced Lung Injury

Ventilatory Parameters and Inflammatory Responses of Neonates Ventilated by Different Modes of Ventilation

Start date: January 2012
Phase: N/A
Study type: Interventional

The main purpose of this study is to investigate effects of SIMV+VG (synchronized intermittent mandatory ventilation+volume guarantee) or PSV+VG (pressure support ventilation+volume guarantee) ventilation on vital signs, patient - mechanical ventilation synchrony, ventilation parameters and inflammatory mediators in neonates.

NCT ID: NCT01502332 Recruiting - Cardiac Disease Clinical Trials

Intensive Alveolar Recruitment Protocol After Cardiac Surgery

Start date: December 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate prospectively the impact of two protective mechanical ventilation strategies, both using low-tidal volume ventilation (6 mL/kg/ibw) after cardiac surgery. The study will select patients presenting signals of deficient gas exchange (PaO2/FIO2 < 250 at a PEEP of 5 cmH2O) in the immediate post-operative period. An aggressive alveolar recruitment protocol applying opening pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, will be compared to the standard alveolar recruitment protocol of the institution, where an opening pressure of 20 cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After a stabilizing period of four hours of controlled mechanical ventilation, the patients will follow the routine weaning protocol and physiotherapy protocol of the institution.

NCT ID: NCT00673517 Completed - Clinical trials for Acute Respiratory Distress Syndrome

The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

Start date: November 2007
Phase: N/A
Study type: Observational

Although mechanical ventilation is life saving, it is associated with a number of severe complications collectively referred to as ventilator induced lung injury (VILI). VILI contributes to the high morbidity and mortality associated with the acute respiratory distress syndrome (ARDS). Within the context of a randomized study evaluating the feasibility of conducting a study comparing high frequency oscillation to conventional lung protective ventilation in early severe ARDS, we are evaluating the effect of both ventilator strategies on biological markers of VILI.