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临床试验/NCT03040297
NCT03040297已完成不适用

Effect of Parallel Oxygen Delivery Through a Tracheal Gas Insufflation (TGI) and a T-piece on Blood Gases and Respiratory Rate in ICU Tracheostomized Patients as an Extra Supporting Method During Weaning From Mechanical Ventilation.

Attikon Hospital2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Respiratory Rate

研究概览

简要总结

The study investigates if there are benefits (better oxygenation, minimized work of breath) from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide respiratory support in tracheostomized patients and avoid mechanical ventilation.

详细描述

The tracheal insufflation (TGI) of respiratory gasses near to carina is a technique who designed for the removement of exhaled carbon dioxide from the dead space of the lung. In order to investigate the utility of this technique on weaning of mechanical ventilation 11 tracheostomized patients on T-piece were recruited, with stable blood gasses more than 24 hours.

A TGI catheter enters the trachea through a new opened hole on the top of T-piece and then passes through the tracheostomy tube to inside of the trachea and then stops one centimeter before the carina. Patients received two parallel administered respiratory gases with the same fraction of inspired oxygen (FiO2), through a T-piece and an endotracheal catheter, with flows 6 Liters Per Minute (L/min) and 11 L/min, while continuously monitored by impedance tomography device (ΕΙΤ). ΕΙΤ is a noninvasive imaging technique for monitoring in real time the lung volumes and the regional lung ventilation without ionizing radiation.

The basic hypothesis of the study is if there are benefits (better oxygenation, minimized work of breath) from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide respiratory support in tracheostomized patients and avoid mechanical ventilation.

The randomization of the study was achieved using sealed envelopes method and associated with the flow to be first (6L/min or 11L/min) via Tracheal Gas Insufflation Catheter (6 envelopes with the inscription 6 L/min on the inner side and 6 envelopes with the inscription 6 L/min on the inner side 11 L/min)

Τhe investigators tested the differences on partial pressure of oxygen (PaO2), respiratory rate and end expiratory impedance:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Tracheostomized haemodynamically stable patients, without the need of vasopressors or inotrope medications, without symptoms of pulmonary edema, or interstitial lung diseases.
  • Stable blood gasses (no bigger changes than 15-20% in Oxygen and Carbon dioxide during last 24 hours)

排除标准

  • Peripheral body temperature < 38 C, White blood cells (WBCs) < 15 x 109/L
  • Respiratory rate >35
  • Paradoxical breathing
  • Abdominal muscle recruitment
  • Dyspnoea, SaO2 < 94, without evidence of angina, cyanosis or arrhythmia.
  • Chest circumferences no bigger than 110 cm (for the larger belt of impedance tomograph)

研究组 & 干预措施

TGI 6 L/min

Active Comparator

Tracheal gas insufflation 6 L/min

干预措施: Tracheal gas insufflation 6 L/min (Device)

TGI 11 L/min

Active Comparator

Tracheal gas insufflation 11 L/min

干预措施: Tracheal gas insufflation 11 L/min (Device)

TGI 0 L/min

Active Comparator

Tracheal gas insufflation catheter, without gas flow

干预措施: Tracheal gas insufflation catheter, without gas flow (Device)

结局指标

主要结局

Respiratory Rate

时间窗: 60 minutes

Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min

partial pressure of oxygen (PaO2)

时间窗: 60 minutes

Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min

End respiratory lung impedance differences

时间窗: 60 minutes

End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min

次要结局

  • Systolic blood pressure(60 minutes)
  • Diastolic blood pressure(60 minutes)
  • Heart Rate(60 minutes)
  • Oxygen saturation (SaO2)(60 minutes)

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Konstantinos Grigoriadis

Physical Therapist

Attikon Hospital

研究点 (2)

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