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Pneumonia, Aspiration clinical trials

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NCT ID: NCT03198988 Terminated - Clinical trials for Aspiration Pneumonia

Functionality and Accuracy of the smART System in Real-Life ICU Settings

Start date: October 26, 2017
Phase:
Study type: Interventional

Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier NCT03689985) there were 2 participants. This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smART™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).

NCT ID: NCT03108430 Recruiting - Risk Factor Clinical Trials

Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

PrevAsPI-Obs
Start date: August 22, 2016
Phase: N/A
Study type: Observational

Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example, there are no data on the incidence of pneumonia after inhalation and risk factors or protective factors to develop one since it is known that anyone who inhaled does not necessarily develop an IP. There is no data on the benefit of treating inhalation by antibiotic therapy pre-emptively although this practice is common. In this context, this observational study wishes to take stock of the situation on the subject in order to determine what actions to implement to prevent IP.

NCT ID: NCT03007862 Recruiting - Clinical trials for Early Aspiration Pneumonia

Bronchial Alpha Amylase as a Marker for Early Aspiration Pneumonia in Therapeutic Hypothermia.

Start date: November 2016
Phase: N/A
Study type: Observational

Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in patients successfully resuscitated after out-of-hospital cardiac arrest. In this prospective non interventional study we included patients resuscitated after cardiac arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar lavage using specific display (Combi-Cath) was executed immediately after admission for each patient with both biochemic and bacteriological analysis including dosage of bronchial salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and biological criteria. On this basis we intended to determine a threshold measure of alpha amylase predicting occurrence of aspiration pneumonia and allowing a guidance in antibiotherapy prescription. Sensibility and Specificity of this technique were determined.

NCT ID: NCT02862314 Completed - Clinical trials for Inhalation Pneumonia

PROcalcitonin Pneumonia / Pneumonitis Associated With ASPIration

PROPASPI
Start date: February 24, 2015
Phase: Phase 4
Study type: Interventional

There is actually no consensus in place defining for which patients with suspected inhalation pneumonia antibiotic treatment should be initiated and what the duration of this antibiotic treatment should be. This absence of recommendations results in excessive use of antibiotics, in emergence of multi-resistant strains and increase of costs. Several studies have been performed investigating antibiotic treatment based on procalcitonin values and have demonstrated a decreased use of antibiotics without change in mortality rates, in duration of hospitalization, in occurrence of super-infections or in infection relapse rate. Of the studies performed in an intensive care setting, none has specifically studied inhalation pneumonia. The objective of this study is to determine whether use of a decisional algorithm based on procalcitonin values allows reducing antibiotics exposure in patients who are intubated because of coma in comparison with standard care according to actual guidelines and clinical experience with respect to ventilator-acquired pneumonia. The study has a prospective, multi-centre, comparative, randomized, open design. It is a superiority study, with as primary parameter the duration of antibiotic therapy during the first 15 days after admission in the intensive care unit (ICU). Patients can be included in this study if they are intubated for coma (Glasgow Coma Scale (GCS) ≤ 8) within 48 hours following admission to the hospital and with a foreseen duration of ventilation exceeding 48 hours. There will be two treatment groups, stratified by centre and randomised in blocs of 4: one group for which treatment initiation and discontinuation will be guided by a procalcitonin-based decisional algorithm and a control group to whom antibiotics will be administered according to the standard protocols of each participating centre. Based on an estimated duration of antibiotic treatment of 6.2 days, a risk -significance α level- of 5%, a power of 90% and a reduction of antibiotic treatment duration of 25% in the treatment arm guided by procalcitonin values, the number of patients to be included is 83 per treatment arm. Taking into account a loss of 10% for patients lost to follow-up, 166 patients should be included.

NCT ID: NCT02858596 Completed - Gastrostomy Clinical Trials

The Effect of Semi-solid Feeding After Percutaneous Endoscopic Gastrostomy (PEG) on the Incidence of Aspiration Pneumonia and Postoperative Length of Stay

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

Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure for long-term enteral tube feeding in patients with insufficient oral intake. Although peristomal site infection is often noted as the most common adverse event after PEG tube placements, it is seldom life-threatening and considered a minor adverse event. Feeding-related adverse events have been identified as the main cause of death after PEG, with up to 50% of postoperative early mortality (30 days) being attributed to aspiration pneumonia. This may be related to the persistence of gastroesophageal reflux (GER) of enteral feed after gastrostomy, even though PEG have been demonstrated to be superior to nasogastric tube feeding in terms of preventing GER. It has been more than a decade since semi-solid feeds were developed as an alternative to conventional liquid feeds to prevent feeding-related adverse events. Unfortunately, there is limited published literature on this topic despite the wide usage of this feeding method in Japan. Amidst the growing popularity of this method and the introduction of National Healthcare Insurance coverage for semi-solid feed prescriptions, we initiated a semi-solid feed protocol along with our existing post-PEG feeding protocols in 2014.

NCT ID: NCT02779595 Completed - Clinical trials for Respiratory Insufficiency

Change of Regional Ventilation During Spontaneous Breathing After Lung Surgery

Start date: June 2016
Phase: N/A
Study type: Observational

Perioperative changes in regional ventilation by pulmonary electrical impedance tomography and spirometry will be investigated in patients at risk for postoperative pulmonary complications. Those patients undergo lung and flail chest surgery.

NCT ID: NCT02720029 Withdrawn - Clinical trials for Acid Aspiration Syndrome

Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients

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

Monitoring and quantification of reflux events in high risk critically ill inpatients and lower risk general medical/surgical inpatients, with comparison to relevant clinical variables.

NCT ID: NCT02705781 Completed - Clinical trials for Aspiration Pneumonia

Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings

Start date: March 23, 2016
Phase: N/A
Study type: Interventional

This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smARTrack™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrack™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smARTrack™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.

NCT ID: NCT02419196 Completed - Clinical trials for Respiratory Insufficiency

Perioperative Change of Regional Ventilation During Spontaneous Breathing

Start date: January 2015
Phase: N/A
Study type: Observational

Perioperative changes in regional ventilation by pulmonary electrical impedance tomography and spirometry will be investigated in patients at risk for postoperative pulmonary complications. Those patients undergo abdominal and limb operations. In a pilot study arm electrical impedance tomography is tested in patients receiving osteosynthesis of serial rib fractures.

NCT ID: NCT02416219 Completed - Clinical trials for Aspiration Pneumonia

Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients

Start date: May 2015
Phase: N/A
Study type: Observational

Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric patients undergoing general anesthesia. Applying cricoid pressure correctly is crucial to prevent aspiration. Using Ultrasound guidance we will be assessing the ability of different disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients by anatomical landmark palpation.