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.
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
- 否
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
Tracheal gas insufflation 6 L/min
干预措施: Tracheal gas insufflation 6 L/min (Device)
TGI 11 L/min
Tracheal gas insufflation 11 L/min
干预措施: Tracheal gas insufflation 11 L/min (Device)
TGI 0 L/min
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
Konstantinos Grigoriadis
Physical Therapist
Attikon Hospital
