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临床试验/NCT04873336
NCT04873336已完成不适用

Tidal Volumes Are Generated Automatically With Closed Loop Ventilation (INTELLIVENT ASV) is Safe in Patients With COVID-19

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Inspiratory Transpulmonary Pressure (Ptpins)

研究概览

简要总结

Transpulmonary pressure may be higher in ARDS patients due to decreased respiratory system compliance. The hypothesis is that tidal volumes which are generated by Intellivent- Adaptive support ventilation (ASV) are safe range by transpulmonary pressure.

详细描述

Patients will be enrolled in the first 24 hours of admission to the intensive care unit. APACHE-2 and SAPS-2 scores will be noted 24 hours after admission. COVID-19 pneumonia will be confirmed according to World Health Organization (WHO) interim guidance. Level of sedation will be monitored with Ramsey Sedation Scale.

An esophageal balloon will be inserted in order to measure transpulmonary pressure(Ptp). The proper localization will be estimated according to ear-nose-xiphoid length. Localization of the balloon will be confirmed with the Baydur maneuver. Mojoli methods will be used to optimize the balloon filling volume.

All patients will be mechanically ventilated under Intellivent-ASV mode. Initial settings will based on predicted body weight. 45 cmH2O will be determined as target end-tidal carbondiokside (ETCO2) but permissive hypercapnia will be allowed if necessary, to maintain lung protective ventilation. Safe pH value will be determined 7.25 independent from ETCO2 levels in patients who will be applied lung protective ventilation. FiO2 and PEEP will be set to maintain an SpO2 of 88-92%.

Ptpinsp will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during inspiratory pause maneuver. Targeted inspiratory transpulmonary pressure (Ptpinsp) was determined to be below 20 cmH2O. If Ptpinsp exceeds 20 cmH2O, minute-volume (MinVol) will be decreased by 10%. Minvol will be reduced below 100% if necessary, to achieve the target. Expiratory transpulmonary pressure (Ptpexp) will be calculated by subtracting the esophageal pressure from the alveolar pressure measured during expiratory pause maneuver. Targeted Ptpexp was determined from 0 to 3 cmH2O. If Ptpexp is below 0 cmH2O, PEEP will be increased until Ptpexp is positive. If Ptpexp exceed 3 mH2O, PEEP will be decreased until Ptpexp is below 3 mH2O. Transpulmonary pressure will be recorded at the beginning after that at least twice daily morning and evening visits. All measurement will be made in passive condition. Transpulmonary pressure measurement will continue until the patient is awake.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID-19 is confirmed with RT-PCR
  • >18 years of age
  • Being intubated less than 24 hours
  • Not being planned to be extubated in 24 hours

排除标准

  • COVID-19 is not confirmed with RT-PCR
  • Having an impaired hemodynamic status
  • Esophageal pathologies
  • Bronchopleural fistula

结局指标

主要结局

Inspiratory Transpulmonary Pressure (Ptpins)

时间窗: The first 24 hours of mechanical ventilation

Ptpinsp will be measured with an inspiratory hold maneuver

次要结局

  • Expiratory Transpulmonary Pressure (Ptexp)(The first 24 hours of mechanical ventilation)

研究者

发起方
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cenk Kirakli, M.D.

Professor Doctor Cenk KIRAKLI

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

研究点 (1)

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