跳至主要内容
临床试验/CTRI/2024/11/076650
CTRI/2024/11/076650招募中不适用

Efficacy in Reduction of Ventilator Associated Pneumonia in Patients with Invasive Mechanical Ventilation with PEEP ZEEP Technique Vs Conventional Method of Suctioning:A Randomised Controlled Study

Heritage Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2024年11月22日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
192
试验地点
1
主要终点
The PEEP-ZEEP technique has been proven to be a safe suction technique,which improves oxygenation without altering hemodynamics in intubated and mechanically ventilated patients. Compared to conventional suction technique it produces elevated expiratory flow that increases the movement of secretions towards the glottis.Hence, this elevated expiratory flow should decrease the incidence of Ventilator Associated Pneumonia in comparison to conventional method of suctioning.

研究概览

简要总结

•Ventilator-associated pneumonia (VAP) refers to pneumonia developed in patients who have been mechanically ventilated for a duration of more than 48 h  and is a major cause of hospital morbidity and mortality. Its incidence differs between 5% and 50% in mechanically ventilated patients

•Critically ill patients with artificial airways have shown changes in mucociliary clearance with the accumulation of secretions due to sedation, depression of the cough reflex, inadequate cuff pressure, inflammation, and mucosal trauma.

•Airway suctioning is often necessary to maintain alveolar permeability and to prevent respiratory tract infection,its classical procedure consists of disconnection from mechanical ventilation, followed by insertion of a suction catheter into the trachea for tracheal suctioning under negative pressure

•According to the guidelines of the American Association for Respiratory Care (AARC),this procedure may result in numerous side effects,such as risks and complication for developing  hypoxia due to reduced tissue oxygenation(Pa02),peripheral oxygen saturation (SPo2),trauma to bronchial mucosa with hemorrhagic secretion ,elevated carbon dioxide levels in the blood(Paco2)  ,changes in hemodynamics

•Difference between Peak expiratory flow rate and Peak inspiratory flow rate >33L/min facilitates the movements of expectoration/secretions  .

•Bacterial transfer from naso-oropharynx and gut to the lower respiratory tract in mechanically ventilated patients via endotracheal tube cuff or by direct cross contamination during nursing intervention results in VAP development.

•Studies have reported that Fio2 1.0 should be the method of choice to prevent lower levels of Pao2 and Spo2, especially during open endotracheal suctioning, as recommended by the latest guidelines of the AARC.

•The PEEP-ZEEP technique is described as a lung inflation through a positive pressure enhancement at the end of expiration (PEEP), followed by rapid lung deflation with an abrupt reduction in the PEEP to 0 cmH2O (ZEEP), associated to a manual bilateral thoracic compression.

•The PEEP-ZEEP technique seems to be safe, without alterations on hemodynamic variables, produces elevated expiratory flow and seems to be an alternative technique for the removal of bronchial secretions in patients .

Aim is to compare the incidence of Ventilator Associated Pneumonia(VAP) between PEEP ZEEP technique Vs conventional method of suctioning in patients with endotracheal/tracheostomy tubes.

.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All age more than 18 years on controlled mechanical ventilation for more than 72 hours.

排除标准

  • Patient/Attendant refusal.
  • Rib fracture ICD insitu Emphysematous bulla Pneumothorax Pleural Effusion Hemodynamic instability requiring noradrenaline more than 10 mcg/min PEEP requirement more than 12 cm H2O for SpO2 more than 92%.
  • Severe bronchospasm(PIP-PPlat more than 20 cm H2O) .
  • Severe Hypoalbuminemia (S.Albumin less than 2.5 g/dl) Ejection fraction less than 40%.

结局指标

主要结局

The PEEP-ZEEP technique has been proven to be a safe suction technique,which improves oxygenation without altering hemodynamics in intubated and mechanically ventilated patients. Compared to conventional suction technique it produces elevated expiratory flow that increases the movement of secretions towards the glottis.Hence, this elevated expiratory flow should decrease the incidence of Ventilator Associated Pneumonia in comparison to conventional method of suctioning.

时间窗: Baseline Samples will be collected before suctioning then,Immediately after then 20 mins post suctioning

次要结局

  • 1)To study the effect of suctioning method on PaO2 and PaCo2 in patients on invasive mechanical ventilation.(2) To study the hemodynamic alterations due to suctioning by PEEP ZEEP technique Vs Conventional method in patients on invasive mechanical ventilation)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Rishabh Gaur

Heritage Institute of Medical Sciences,Varanasi

研究点 (1)

Loading locations...

相似试验

A clinical trial comparing the efficacy of PEEP ZEEP... | 临床试验