Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pulsated oxygen saturation (Sp02)
研究概览
简要总结
High-throughput oxygen therapy is known as an alternative to non-invasive ventilation, with a benefit in terms of survival in non-hypercapnic respiratory failure patients.
The use of high-throughput oxygen therapy is well studied in stable chronic obstructive pulmonary disease (COPD) patients and has as known effects the decrease of transcutaneous CO2 and respiratory rate, and the increase in the inspiratory/expiratory time report, in the tidal volume and in the forced expiratory volume per second.
In the event of an exacerbation, high-flow oxygen therapy has shown to be beneficial in terms of increased mean airway pressure, tidal volume with a decrease in hypercapnia, and respiratory rate.
The net effect on the CO2 pressure is linked to the CO2 clearance of the dead anatomical space by the high throughput. The effect can be compared with the one of non invasive ventilation in a stable COPD patient.
Oxygen therapy, even in patients with non-hypoxic COPD at rest, has benefits in terms of performance and improvement of quality of life. High-throughput oxygen therapy has also shown a benefit in COPD patients in revalidation units, in terms of exercise performance and oxygenation.
However, the reconditioning of critical patients in acute situations, by means of nasal goggles, has never been studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Acute respiratory insufficiency type I, oxygen partial pressure (PaO2) <60 mmHg under oxygen without hypercapnia.
- •Invasive arterial pressure measure
排除标准
- •Hemodynamic instability
- •Patient under continuous high throughput oxygen therapy
- •Left cardiac insufficiency
- •Arteritis of the lower limbs
- •Neuromuscular pathology
- •Osteo-articular limitations
- •Hemoglobin inferior to 8g/dl
研究组 & 干预措施
Optiflow nasal googles
Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher&Paykel- New Zealand).
干预措施: Cyclometer Ergometer (Device)
Venturi mask
Oxygen provided by means of a Venturi mask.
干预措施: Cyclometer Ergometer (Device)
结局指标
主要结局
Pulsated oxygen saturation (Sp02)
时间窗: 12 minutes (maximal effort)
SpO2 is an estimate of the amount of oxygen in the blood. More precisely, it represents the percentage of oxygenated hemoglobin (containing oxygen) relative to the total amount of hemoglobin in the blood (oxygenated hemoglobin and non-oxygenated hemoglobin).
Oxygen inspired fraction (FiO2)
时间窗: 12 minutes (maximal effort)
Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Blood gasometry
时间窗: 12 minutes (maximal effort)
Arterial blood analysis
Heart rate
时间窗: 12 minutes (maximal effort)
The heart rate is the number of heartbeats per minute.
Respiratory rate
时间窗: 12 minutes (maximal effort)
Number of breath cycles (inspiration and expiration) per minute.
Mean arterial pressure
时间窗: 12 minutes (maximal effort)
Mean arterial pressure
Systolic blood pressure
时间窗: 12 minutes (maximal effort)
Systolic blood pressure (pressure in the artery as the heart contracts)
Borg score
时间窗: 12 minutes (maximal effort)
The Borg scale is a quantitative measure of the perception of effort during exercise. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the cardiac frequency).
Forced expiratory volume per second (FEV1)
时间窗: Baseline
The "Forced Expiratory Volume Per Second" (FEV1) is the volume of air exhaled during the first second of a so-called "forced" exhalation, following deep inspiration. It is measured by spirometry.
Functional residual capacity (CFR)
时间窗: Baseline
Volume of air remaining in the airways after a spontaneous expiration (not forced)
Respiratory rate
时间窗: Baseline
Number of breath cycles (inspiration and expiration) per minute.
Pulsated oxygen saturation (Sp02)
时间窗: Baseline
SpO2 is an estimate of the amount of oxygen in the blood. More precisely, it represents the percentage of oxygenated hemoglobin (containing oxygen) relative to the total amount of hemoglobin in the blood (oxygenated hemoglobin and non-oxygenated hemoglobin).
Oxygen inspired fraction (FiO2)
时间窗: Baseline
Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Blood gasometry
时间窗: Baseline
Arterial blood analysis
Heart rate
时间窗: Baseline
The heart rate is the number of heartbeats per unit minute.
Mean arterial pressure
时间窗: Baseline
Mean arterial pressure
Systolic blood pressure
时间窗: Baseline
Systolic blood pressure (pressure in the artery as the heart contracts)
次要结局
- Age(Baseline)
- Weight(Baseline)
- Sex(Baseline)
研究者
Dr David DE BELS
Head of intensive care unit
Brugmann University Hospital