Influence of Mechanical Ventilation Modes on the Efficacy of Nebulized Bronchodilator in the Treatment of Patients With Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in tidal Impedance Variation
研究概览
简要总结
Aerosol therapy is widely used in intensive care in critically ill patients that use mechanical ventilation (MV). However, there is a lack of standardization about aerosol performance in this group of patients. Thus, this study aims to evaluate the effect of nebulization performed in different ventilatory modes on lung function and regional pulmonary distribution of critical patients with chronic obstructive pulmonary disease. It is a clinical trial, crossover, randomized, controlled and blind. Three interventions with bronchodilators will be performed: in the Pressure Controlled Ventilation mode (PCV) with positive end expiratory pressure (PEEP) = 85% of autoPEEP, in the PCV mode with PEEP = 15 cmH2Oand in the Pressure Support Mode (PSV). Pulmonary function data will be evaluated through Electrical Impedance Tomography to evaluate the efficacy of the bronchodilator in different ventilatory modes.
详细描述
- OBJECTIVES
2.1 Primary
• To evaluate the influence of mechanical ventilation modes in the efficacy of nebulized bronchodilator in ventilator dependent patients with obstructive pulmonary disease.
2.2 Secondary
- To compare regional ventilation distribution through Ventilation Surface Area (VSA) and Tidal Impedance Variation (TIV or ∆Z) by electrical impedance tomography (EIT) before, immediately after, after 1hour (h), 2h and 3h of nebulized bronchodilator in pressure controlled ventilation (PCV) with and without sedative drugs, and during pressure support ventilation (PSV).
- To compare the peak expiratory flow (PEF), change in End-Expiratory Lung Volume (dEELV), Respiratory Compliance (Crs) and Resistance (R), before, immediately after, after 1h, 2h and 3h of nebulized bronchodilator by monitoring airway pressure and EIT in ventilator modes PCV, with and without sedative drugs and PSV .
- To compare the ventilator modes on the VSA, ∆Z, PEF, dEELV and Crs after nebulized bronchodilator and the duration of its effects during mechanical ventilation.
- To compare two different level of PEEP during nebulized bronchodilator on PCV mode while the patient stay with sedative drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant is blind about the procedures. The investigator is blind about order of procedure and outcomes assessor is blind about procedures.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with asthma or chronic obstructive pulmonary disease (COPD) Invasive mechanical ventilation Hemodynamically stable
排除标准
- •Prescribed metered dose inhaler (MDI) or intravenous bronchodilators Undrained pneumothorax Bronchopleural fistula Chest trauma Tracheoesophageal fistula Tracheal granulomas Tracheal stenosis PEEP dependence
- •Contraindicated disconnection of the MV
- •Endotracheal tube diameter less than 7.5
- •Do not make part of the protocol of daily sedation
- •No regular ventilatory drive when with out sedation
- •Do not reach a minimum tidal volume 6 ml/kg with a maximum peak pressure (PIP) of 35 cmH2O (centimeter of water) during MV.
- •Do not use the same MV modes that will be tested in this study
研究组 & 干预措施
Pressure-controled-ventilation (PCV)
Nebulization during mechanical ventilation on a pressure controled ventilation mode.
干预措施: salbutamol sulfate and ipratropium bromide (Drug)
Pressure-controled-ventilation (PCV)
Nebulization during mechanical ventilation on a pressure controled ventilation mode.
干预措施: Mesh nebulization (Device)
PCV and high PEEP
Nebulization during mechanical ventilation on a pressure controled ventilation mode and PEEP = 15 cmH2O.
干预措施: salbutamol sulfate and ipratropium bromide (Drug)
PCV and high PEEP
Nebulization during mechanical ventilation on a pressure controled ventilation mode and PEEP = 15 cmH2O.
干预措施: Mesh nebulization (Device)
Pressure suport ventilation (PSV)
Nebulization during mechanical ventilation on a pressure suport ventilation mode.
干预措施: salbutamol sulfate and ipratropium bromide (Drug)
Pressure suport ventilation (PSV)
Nebulization during mechanical ventilation on a pressure suport ventilation mode.
干预措施: Mesh nebulization (Device)
结局指标
主要结局
Change in tidal Impedance Variation
时间窗: change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator
compare regional ventilation distribution by electrical impedance tomography
次要结局
- Change in compliance of respiratory sistem (cmH2O)(change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator)
- Change in End-Expiratory Lung Volume(change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator)
- Change in peak expiratory flow (lpm)(change from baseline immediately after and at 1, 2, 3 hour of nebulized bronchodilator)
研究者
Cibelle Andrade Lima
Principal Investigator
Universidade Federal do Rio Grande do Norte