A Prospective Pilot Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Determine the effect of an increase in positive end-expiratory pressure on intrathoracic pressure variables in patients with acute respiratory failure.
研究概览
简要总结
Previous research has shown that the Inferior Vena Cava Collapsibility Index (IVCCI) can be used to assess volume status. One limitation of the previous work is that changes in intra-thoracic pressure can influence this measurement, and the magnitude of this effect has never been described. The investigators aim is to correlate the degree of change in IVCCI with the set degree of change in intra-thoracic pressure in a heterogeneous population of critically ill patients.
详细描述
Initially eligible patients will be those admitted to the OSU MICU and 8ICU within the prior 48 hours. These patients will be screened for predetermined exclusion criteria. Eligible patients will have their IVCCI measured and baseline peak and plateau pressures noted. For those patients meeting a second set of criteria, a common ventilator maneuver will be preformed. The positive end-expiratory pressure will be increased by 5-10 cm/H20 pressure. This procedure will be aborted if ANY safety criteria are exceeded. During the interval, the IVCCI will be re-measured, the ventilator settings will be recorded, and the ventilator will be return to the initial settings. Since changes of these same magnitude are made daily in clinical practice, the risks to the patients in this study will be minimal and no more than that experienced in the course of usual care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>17 years
- •Current use of mechanical ventilation through an endotracheal tube.
- •Admitted to ICU within last 48 hours
排除标准
- •Severe COPD by history (documented FEV1<50% predicted or CT evidence of emphysema)
- •Current suspected Asthma Exacerbation
- •Profound Hypoxia defined as a FiO2 requirement >90% or a PEEP >10 mmHg
- •Patient-ventilator desynchrony or active agitation
- •Unstable O2 requirement as determined by the primary clinical team.
- •Bedside clinician refusal (physician or treating nurse).
- •Exclusion Criteria for ventilator changes:
- •Cardiovascular instability (any increase in rate of vasopressors or i.v. fluid bolus for hypotension within the last four hours)
- •Current PEEP requirements of >15cmH2O
- •Current SpO2 of <88%.
结局指标
主要结局
Determine the effect of an increase in positive end-expiratory pressure on intrathoracic pressure variables in patients with acute respiratory failure.
时间窗: 24 months
1. Determine the effect on inferior vena cava collapsibility index of an increase in positive end-expiratory pressure (and resultant change in mean airway pressure) in patients with acute respiratory failure. 2. Determine the effect on central venous pressure of an increase in positive end-expiratory pressure (and resultant change in mean airway pressure) in patients with acute respiratory failure. 3. Determine the effect on mean airway pressure of an increase in positive end-expiratory pressure in patients with acute respiratory failure.
次要结局
- Determine the relationship between central venous pressure and inferior vena cava collapsibility index at varying levels of mean airway pressure (MAP).(24 Months)
- Determine the inter-rater reliability in obtaining inferior vena cava collapsibility index ultrasound images.(24 months)
研究者
Naeem Ali, MD
Associate Professor-Clinical
Ohio State University