High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Respiratory drive
研究概览
简要总结
The goal of this study is to evaluate the role that high-flow nasal cannulas (HFNC) have on respiratory drive, work of breathing and neuromuscular efficiency after lung resection surgery. The main question the investigators aim to answer is whether HFNC decrease respiratory drive by at least 15% in these patients, assessed by a special diaphragmatic electromyography (EMG) device (NAVA catheter). In order, to perform this study, the investigators will perform a physiological study in 40 patients. These patients will be assessed in the immediate postoperative period and HFNC will be compared to conventional face-mask therapy.
详细描述
Single centre, physiological crossover clinical trial in 40 patients in the immediate postoperative period after lung resection, equipped with a NAVA catheter to monitor diaphragm electrical activity (EAdi) and assess the effects that HFNC have on the respiratory drive and work of breathing as compared to conventional facemask oxygen therapy. Once in the postoperative care unit (PACU) and 1) after recovery from anaesthesia, 2) cardiorespiratory stable and 3) pain-free (see below), the intervention will start. The study will assess the effect of HFNC and oxygen via face mask on EAdi and diaphragm function, as measured by ultrasonography. HFNC and oxygen via face mask order will be randomized in a sequence (A-B or B-A) with the aid of a website (www.randomization.com). Each intervention will last for 30 minutes. The oxygen-inspired fraction (FiO2) will be adjusted to maintain a pulse oximetry (SpO2) between >92%. In the case of the high-flow nasal cannula, the study will be carried out with a flow of 50 L/min.
EAdi signal will be continuously monitored and its signal later exported to a laptop for further analysis. At the end of the 30-minute period, a blood sample will be obtained for gas analysis from the arterial line and the investigators will perform a diaphragm ultrasonography. Ultrasonography will consist of measurement of diaphragm thickness and thickening on the right side during quiet breathing and diaphragmatic excursion on both sides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Subjects submitted to lung resection with an expected mechanical ventilation time of more than 180 minutes.
排除标准
- •Patient refusal to participate
- •Contraindications to nasogastric tube placement (i.e. oesophageal varices)
- •Patients less than 18 years old
- •Pregnancy
- •Neuromuscular disease
- •Prior thoracic surgery
结局指标
主要结局
Respiratory drive
时间窗: Mean or median EAdi for both conditions (30 minutes each)
Respiratory drive will be assessed as maximal EMG activity during each respiratory cycle (peak EAdi of the NAVA catheter)
次要结局
- Oxygenation(An arterial blood sample will be obtained at the end (30 min) of each study condition)
- Thickening fraction of the right hemidiaphragm(An ultrasound will be performed 25 minutes after starting each study condition)
- Dyspnea(Dyspnea presence by VAS will be assessed at the 30-minute mark of each condition (end of each condition) and will evaluate dyspnea for the whole condition (30 minutes).)
- Diaphragmatic excursion(An ultrasound will be performed 25 minutes after starting each study condition)
- Ventilation(An arterial blood sample will be obtained at the end (30 min) of each study condition)
研究者
Ricard Mellado Artigas
Principal Investigator
Hospital Clinic of Barcelona