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临床试验/NCT05530434
NCT05530434终止不适用

Transpulmonary Pressure Guided Weaning From Invasive Mechanical Ventilation in Obese Patients With Respiratory Failure

University of Mississippi Medical Center2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年4月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Ventilator free days

研究概览

简要总结

This study will look at whether accounting for the amount of pressure generated by the chest wall and abdomen in a obese patient, using a measurement called transpulmonary pressure, can help shorten the amount of time patients spend on the ventilator. By decreasing the amount of time patients spend on the ventilator, they are less likely to develop complications such as infections, weakness or more procedures.

详细描述

Managing obese patients on the ventilator can be difficult due to the changes in their respiratory mechanics with little evidence as to best practices. This research will assess the utility of transpulmonary pressures in guiding mechanical ventilation in obese patients. This study with specifically look at whether using transpulmonary pressure guided positive end expiratory pressure (PEEP) titration for ventilation and spontaneous breathing trials (SBT) will shorten the time to liberation for obese patients on invasive mechanical ventilation for respiratory failure. The transpulmonary pressures will be calculated daily for all patients. Patients will also be assessed daily for readiness for SBT. In the intervention group, subjects' PEEP will be titrated to achieve an end expiratory transpulmonary pressure of 0-2 cm H2O. This PEEP will be used for the SBT and clinicians will be encouraged to keep their patients on this PEEP after the SBT if they are not extubated. In the control group, patients will also be assessed daily for SBT readiness but will be managed with standard set pressures of 5 to 10 cm H2O of PEEP and 5 to 8 cm H2O of pressure above PEEP. The primary team can perform a T piece trial prior to extubation as clinically indicated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • on invasive mechanical ventilation for respiratory failure for < 48 hours
  • obese class II or higher (BMI greater than or equal to 35.0 kg/m2)

排除标准

  • contraindications to esophageal balloon catheter placement including esophageal, nasofacial, gastrointestinal abnormalities and platelets <10,000/microliter
  • known pleural disease such as persistent pneumothorax, pleural effusion, or pleurodesis
  • neuromuscular disease
  • requires chronic mechanical ventilation prior to enrollment
  • severe neurologic injury
  • known difficult airway
  • life expectance is less than 48 hours

研究组 & 干预措施

Transpulmonary pressure guided positive end expiratory pressure

Experimental

Patients in this group will have the positive end expiratory pressure on the ventilator set to a transpulmonary pressure of 0-2 cm H2O during ventilation and spontaneous breathing trials.

干预措施: transpulmonary pressure guided positive end expiratory pressure (Other)

Standard positive end expiratory pressure

Active Comparator

Patients in this groups will have the positive end expiratory pressure on the ventilator set by the clinician during ventilation and set to a standard positive end expiratory pressure of 5-8 cm H2O during spontaneous breathing trials.

干预措施: standard positive end expiratory pressure (Other)

结局指标

主要结局

Ventilator free days

时间窗: 30 days

Number of ventilator free days

次要结局

  • Re-intubation rate(30 days)
  • Mortality(30 days)
  • Number of tracheostomies(30 days)
  • PEEP at extubation(30 days)
  • Days on invasive mechanical ventilation(30 days)
  • Intensive care unit length of stay(30 days)
  • Hospital length of stay(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meredith E. Sloan

Instructor

University of Mississippi Medical Center

研究点 (2)

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