Influence of Automatic Oxygen Titration Device (FreeO2) on Percentage of Time Within Oxygen Saturation Target and Induced Hypercapnia During Noninvasive Ventilation for Patients Hospitalized for an Acute Exacerbation of COPD or a Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of time within SpO2 target
研究概览
简要总结
The main objective is to evaluate the FreeO2 device combined with noninvasive respiratory support technique for COPD patients and postoperative bariatric surgery patients.
The main hypothesis is that FreeO2 device for oxygen therapy associated with NIV or nasal high flow oxygen therapy (NHFOT) allows to reach better oxygenation and avoid hypoxemia and hyperoxia.
详细描述
Bariatric surgery patients:
The main objective of this study is to evaluate the time spent in the SpO2 target (+/- 2% SpO2 target) and partial pressure of carbon dioxide (PCO2) values on patients with morbid obesity after bariatric surgery.
COPD patients:
The main objective of this study is to evaluate the time spent in the SpO2 target (+/- 2% SpO2 target) and PCO2 values on patients with exacerbation of COPD (hypercapnic patients) with different ventilatory supports (NIV and NHFOT) associated with FreeO2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Respiratory acidosis (pH <= 7.35 and PaCO2 > 45 mmHg), with or without NIV (last blood gas available during hospitalization)
- •Oxygen therapy and/or SpO2 <90% room air (FiO2 <= 50% or nasal cannula <= 7 L/min to maintain SpO2 90%)
- •High flow nasal cannula with flow <= 30 L/min
- •Inclusion Criteria (Bariatric surgery post-op):
- •Patients using CPAP before the surgery (obstructive sleep apnea documented).
- •Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included.
排除标准
- •Age < 18
- •Pregnancy
- •Respiratory distress or other clinical situation requiring continuous NIV or CPAP
- •Glasgow < 12 or agitation/delirium/dementia (limiting NIV)
- •Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)
- •Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)
- •Refusal to consent to the study
- •5 patient with AECOPD and 5 patient with bariatric surgery will be included.
研究组 & 干预措施
Bariatric surgery patients
Obese patients after gastric surgery under CPAP.
干预措施: CPAP - Oxygen constant flow (Other)
Bariatric surgery patients
Obese patients after gastric surgery under CPAP.
干预措施: CPAP - FreeO2 (Other)
COPD patients
Patients with acute exacerbation of COPD and respiratory acidosis under oxygen therapy.
干预措施: Washout period (Other)
COPD patients
Patients with acute exacerbation of COPD and respiratory acidosis under oxygen therapy.
干预措施: NIV - FreeO2 (Device)
COPD patients
Patients with acute exacerbation of COPD and respiratory acidosis under oxygen therapy.
干预措施: Nasal High flow Oxygen therapy - FreeO2 (Device)
结局指标
主要结局
Percentage of time within SpO2 target
时间窗: AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).
(SpO2 90 +/- 2%)
次要结局
- PCO2 value after each period(AECOPD Patients: Day 1; 30 minutes, 60 minutes, 90 minutes, 120 minutes after start study procedures. Bariatric surgery patient: Day 1; 15 minutes and 75 minutes after start study procedures.)
- Percentage of time in hyperoxia(AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).)
- Percentage of time in severe hypoxemia(AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).)
- Percentage of time in hypoxemia(AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).)
研究者
François Lellouche
Principal Investigator
Laval University