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临床试验/NCT03856424
NCT03856424Unknown不适用

Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients. Monocentric Crossover Interventionnal Study.

Piquilloud Imboden Lise2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年3月8日最近更新:
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适应症

试验速览

阶段
不适用
发起方
入组人数
18
试验地点
2
主要终点
Evolution of pressure-time product of esophageal pressure
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described.

This crossover physiology study will include 18 tracheostomized patients ventilated for more than 72 hours.

The objective of this study is to compare the effect of three different modalities of SBTs on respiratory effort in tracheostomized patients. The modalities tested are : Pressure Support Ventilation (PSV level 5 cmH2O, PEEP 5 cmH2O), T-piece test and high-flow Oxygen. Each modality is applied in a randomized order, during 30 minutes. During every modality tested, esophageal and gastric pressure, expired CO2, and comfort will be monitored, in addition to standard monitoring. Based on esophageal pressure monitoring, patient's respiratory efforts can be calculated either by esophageal pressure-time product and work of breathing. Pressure generated by inspiratory muscles will also be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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
否

入选标准

  • •Patients for whom a tracheostomy is planned
  • •Patients on invasive ventilation for >72 hours

排除标准

  • •Tracheostomy for upper airway obstruction or other disease
  • •Patients tracheostomized before current hospitalization
  • •Patients with Glasgow Coma Scale (GCS) < 8/10 after cardiac arrest
  • •Patients with GCS < 8/10 because of primary central neurologic disease
  • •Patients for whom therapeutic limitations have already been decided
  • •Patients for whom weaning from ventilation is not an objective
  • •Patients suffering from myasthenia gravis
  • •Patients with cardiac assistance device
  • •Patients with medullary lesion proximal to C5
  • •Patients for whom nasogastric tube insertion is contraindicated

结局指标

主要结局

Evolution of pressure-time product of esophageal pressure

时间窗: Recorded every 5 minutes during each sequence and washout period, 180 minutes

Quantification of inspiratory effort of the patient

次要结局

  • Evolution of work of breathing (WOB)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of inspiratory muscle pressure (Pmus)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of tidal volume (VT)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of transdiaphragmatic pressure (Ptransdiaph)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of inspiratory airway flow(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of blood pressure(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of chest wall compliance (Ccw)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of esophageal pressure drop(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of respiratory rate (RR)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of Rapid Shallow Breathing Index (RSBI)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of ratio of total dead space volume over tidal volume(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of Plateau pressure (Pplat)(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
  • Evolution of intrinsic Positive End-Expiratory Pressure (PEEPi)(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
  • Pulmonary strain(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of total dead space volume(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of Diaphragmatic excursion (DE)(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
  • Evolution of Diaphragmatic thickening fraction (DTF)(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
  • Evolution of hematocrits(Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes)
  • Evolution of ratio of inspiratory time over total duration of a breathing cycle (ti/ttot)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of respiratory system compliance (Crs)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of lungs compliance (CL)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of transpulmonary pressure (Ptranspulm)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of total Positive End-Expiratory Pressure (PEEPtot)(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of heart rate(Recorded every 5 minutes during each sequence and washout period, 180 minutes)
  • Evolution of Richmond Agitation/Sedation scale (RASS) score(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
  • Evolution of Borg dyspnea scale score(Recorded at minute 1 and minute 30 of each three spontaneous Breathing Trial, 90 minutes)
  • Evolution of Multidimensionnal dyspnea scale (MDP) score(Recorded at minute 30 of each three spontaneous Breathing Trial, 90 minutes)

研究者

发起方
Piquilloud Imboden Lise
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Piquilloud Imboden Lise

Sponsor-investigator

University of Lausanne Hospitals

研究点 (2)

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