Advertisement

Topics

Tracheobronchitis Prevention Trial

2014-07-24 14:10:42 | BioPortfolio

Summary

The investigators aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of tracheal tube and upper airways.

Description

INTRODUCTION Gram-negative bacteria have recently become endemic in many ICUs around the world. Ventilator associated pneumonia (VAP) is relatively common and its parenteral treatment often leads to low and sub-therapeutic concentrations of antibiotics in the lung. Ventilator associated tracheobronchitis (VAT) is characterized by fever, purulent sputum, positive cultures of tracheal aspirates secretions and the absence of new pulmonary infiltrates on CXR. This entity is of particular interest because it is an intermediate step in the pathogenesis of VAP (between colonization and VAP itself) and prolongs mechanical ventilatory support. Inhaled antibiotics achieve high (both peak and trough) concentrations in respiratory secretions. Endobronchial antibiotics have been given to non-cystic fibrosis patients for prevention of VAP. Colistimethate sodium (colistin) given by instillation decreased the incidence of Gram-negative pneumonia and did not lead to the development of colistin resistant bacteria.

AIM

The study is a prospective open label randomized study which aims to clarify the effect of colistin to:

1. The incidence of VAP

2. The incidence of VAT

3. Mechanical ventilation days

4. Duration of ICU stay

5. Incidence of multidrug resistant bacteria in tracheal aspirates cultures

6. Antibiotic consumption

7. Quality and quantity of secretions

METHODS Settings: The study will be performed in the ICU of the University of Larissa (10 beds).

Entry criteria: All intubated and trachestomised patients, older than 18 years old with duration of intubation of 48 hours.

Exclusion criteria: 1) Purulent sputum within 48 hours from admission. 2) Pneumonia within 48 hours of intubation 3) New chest X ray infiltrate, 4) Advanced COPD that led to intubation 5) Pregnancy 6) Allergy to colistin 7) Resistance of the bacterial strain to colistin.

Tools: Randomization of the patients into two groups: the first group will receive nebulized colistin and the other no treatment. The initial dose is 1000000 units and it will be doubled after measurement of the drug concentration in tracheal secretions. The drug will start on admission and stop after 10 days.

All patients will be given the respiratory bundle measures (semi-recumbent position, daily interruption of sedation) as part of the usual daily practice of our ICU except otherwise indicated.

The severity of patients will be estimated by APACHE II score on admission and SOFA score thrice weekly. CPIS score as a screening tool for pneumonia will be estimated as well thrice weekly.

Tracheal aspirates cultures on admission and thrice weekly thereafter. The patients will be followed for thirty days to measure outcome.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Tracheobronchitis

Intervention

Tadim, inhaled normal saline

Location

University hospital of Larissa
Larissa
Greece
41110

Status

Recruiting

Source

University of Thessaly

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:42-0400

Clinical Trials [1075 Associated Clinical Trials listed on BioPortfolio]

Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever, and purulent sputum, but without radiological evidence of pneumonia. These patients may have tr...

Therapy of Ventilator-associated Tracheobronchitis Caused by Gram Negative Bacteria With Nebulized Colistin

The purpose of this study is to determine whether inhaled colistin is effective in the treatment of ventilator associated tracheobronchitis due to gram negative organism susceptible to col...

Half-normal Saline in Atrial Fibrillation Ablation

The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-media...

Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis

The aim of this study is to determine whether antibiotic treatment could reduce mechanical ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical vent...

Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis

This is an open-label pilot study of the safety and tolerability of 7% hypertonic saline inhaled twice daily for 14 days in infants with CF, 12 to 30 months of age.

PubMed Articles [5240 Associated PubMed Articles listed on BioPortfolio]

Effects of intraoperative and early postoperative normal saline or Plasma-Lyte 148® on hyperkalaemia in deceased donor renal transplantation: a double-blind randomized trial.

Administration of saline in renal transplantation is associated with hyperchloraemic metabolic acidosis, but the effect of normal saline (NS) on the risk of hyperkalaemia or postoperative graft functi...

Bronchoscopic Improvement of Tracheobronchitis Due to Methicillin-Resistant Staphylococcus aureus After Aerosolized Vancomycin: A Case Series.

Ventilator-associated tracheobronchitis (VAT) is an important risk factor for ventilator-associated pneumonia (VAP). The efficacy of aerosolized vancomycin (AV) in treating VAT has not been clearly de...

University of Wisconsin versus Normal Saline Solutions for Preservation of Blood Vessels of Brain Death Donors; A Histopathological Study.

To compare the cellular changes of harvested arteries which were preserved in normal saline (NS) and the standard and routinely used university of Wisconsin (UW) solution.

New opportunities for inhaled therapy for inflammatory diseases of the respiratory system.

The paper considers current approaches to mucoregulatory therapy for various inflammatory diseases of the respiratory system. It gives the advantages and disadvantages of common drugs used in their tr...

The cost-effectiveness of hypertonic saline inhalations for infant bronchiolitis: a decision analysis.

This study evaluated the cost-effectiveness of hypertonic saline (HS) inhalations for infant bronchiolitis, compared to normal saline inhalations or standard treatment without inhalations as controls.

Medical and Biotech [MESH] Definitions

A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.

A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.

Illicit use of chemicals and products whose vapors can be inhaled to produce a rapid mind-altering effect. Inhalants include aerosols, gases, and volatile solvents that are often inhaled repeatedly to achieve the short-lived intoxicating effect.

A species of PERCIFORMES commonly used in saline aquaculture.

Measurement of volume of air inhaled or exhaled by the lung.

More From BioPortfolio on "Tracheobronchitis Prevention Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Pneumonia
Pneumonia (bronchopneumonia, lobar pneumonia and double pneumonia) is inflammation (swelling) of the tissue in one or both of your lungs. It is usually caused by an pneumococcal infection caused by bacteria called Streptococcus pneumoniae.  However,...

Respiratory
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...


Searches Linking to this Trial