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临床试验/CTRI/2024/04/066342
CTRI/2024/04/066342尚未招募4 期

Study of microbiological isolates and antibiotic susceptibility patterns in suspected cases of ventilator-associated pneumonia with bronchoscopy-based surveillance technique in ICU

School of Medical Sciences and Research Sharda University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
3. To correlate Clinical Pulmonary Infection Score values with ventilator associated pneumonia

研究概览

简要总结

Ventilator-associated pneumonia (VAP) is a hospital-acquired lung infection that occurs in patients, who are mechanically ventilated for at least 48 hours, either through tracheostomy or endotracheal intubation.1,2 It is divided into early (within 4 days after mechanical ventilation) and late (from the fifth day onwards).2 This disease is the second most common nosocomial infection in intensive care unit patients.3,4 The microbial causes of ventilator-associated pneumonia vary considerably by geographic location and over time. The most common pathogens involved in ventilator-associated pneumonia are bacteria including E.coli, Klebsiella(gram-negative bacilli) and Staphylococcus aureus (gram-positive coccus). There are variousother causative organisms like Pseudomonas species and Acinetobacter species that are resistant to different antibiotics and are referred to as multidrug-resistant (MDR) species4,5 As per standardized international terminology created by European Centre for Disease Control (ECDC) and Centre for Disease Control & Prevention (CDC), Atlanta, the multidrug-resistant (MDR) and extensively drug-resistant (XDR) have been well defined. The term MDR or multidrug-resistant bacteria denotes those bacteria that have acquired resistance to one or more agents within three or more antimicrobial categories. Extensively drug-resistant (XDR)bacteria denote those that have acquired resistance to at least one antimicrobial agent in all but two antimicrobial categories. VAP is suspected in patients with clinical signs of infection, such as at least two of the following criteria: new onset of fever, purulent endotracheal secretions, leucocytosis or leukopenia, increase in minute ventilation, decline in oxygenation and/or increased need for vasopressors to maintain blood pressure.The risk factors associated with ventilator-associated pneumonia include the duration of mechanical ventilation, underlying lung disease, infection, acute respiratory distress syndrome, neurological disorder, trauma, prior antibiotic usage and red cell transfusion6. VAP is believed to occur in 8% to 28% of mechanically ventilated patients.2,7 The incidence of VAPattributable mortality is difficult to quantify due to the possible confounding effect of associated conditions, but VAP is thought to increase the mortality of the underlying disease by about 30%.8 VAP is also associated with considerable morbidity, including prolonged ICU length of stay, prolonged mechanical ventilation and increased costs of hospitalization. Flexible fibre-optic bronchoscopy is a routinely used invasive diagnostic procedure employed for the diagnosis of various pulmonary diseases and aids in their adequate management. In patients with ventilator-associated pneumonia, bronchoscopy has a diagnostic as well as 2therapeutic role. This includes aspiration of retained secretions & mucous plugs, administration of drugs and bronchoalveolar lavage. One major technical problem with all bronchoscopic techniques is the proper selection of the sampling area in the tracheobronchial tree. Usually, the sampling area is selected based on the location of the infiltrate on the chest radiograph or the segment visualized during bronchoscopy having purulent secretions9. In case of doubt and because autopsy studies indicate that ventilator-associated pneumonia frequently involves the posterior portion of the right lower lobe, this area should probably be sampled on priority.10The risk inherent in bronchoscopy appears slight even in critically ill patients requiring mechanical ventilation, although the associated occurrence of cardiac arrhythmias, hypoxemia, or bronchospasm is not unusual.Microbiological analysis samples from the lower respiratory tract can be obtained by bronchoalveolar lavage, protected-specimen brush and direct lung aspirates. Among these techniques, bronchoalveolar lavage provides the most accurate representation of the bacterial burden in the lungs.11 Bronchoalveolar lavage (BAL) has been shown to be reliable for the identification of microorganisms present in the lung specimens of patients with bacterial pneumonia.12,13Bronchoalveolar lavage (

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with a clinical suspicion of ventilator associated pneumonia 2.Mechanically ventilated for more than 48 hours 3.Age 18 years and above 4.Both genders.

排除标准

  • 1.Patients with a clinical suspicion of ventilator associated pneumonia 2.Mechanically ventilated for more than 48 hours 3.Age 18 years and above 4.Both genders.

结局指标

主要结局

3. To correlate Clinical Pulmonary Infection Score values with ventilator associated pneumonia

时间窗: in duration 4 weeks

1.To identify microbes associated with ventilator-associated pneumonia & examine

时间窗: in duration 4 weeks

their antibiotic sensitivity patterns.

时间窗: in duration 4 weeks

prevalent in ICU.

时间窗: in duration 4 weeks

2.To identify multi-drug resistant & extensive drug-resistant organisms

时间窗: in duration 4 weeks

次要结局

  • N/A(N/A)

研究者

发起方
School of Medical Sciences and Research Sharda University
申办方类型
Private medical college

研究点 (1)

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