Comparative Study on the Effectiveness, Comfort and Compliance of High-flow Nasal Oxygen Therapy and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- height
研究概览
简要总结
Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. patients in group A were first treated with HFNC on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. patients in group B were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with HFNC until discharge. Patient information was collected during treatment.
详细描述
Patients who met the inclusion criteria were included and signed the informed consent, which met the requirements of the ethics committee of our unit. All subjects were hospitalized patients. Subjects were randomly divided into two groups. Patients in group A were treated with HFNC on the basis of conventional treatment. The initial parameters were: temperature:31-37℃, flow: 30-40l /min, SpO2 > 92% maintained, the oxygen concentration was adjusted according to the patient's oxygen saturation, and the treatment time was 24h. Twenty-four hours later, the patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. On the basis of conventional treatment, patients in group B were given a non-invasive ventilator with the following initial parameters: BiPaP mode, initial inspiratory pressure (IPAP) of 8-15cmH2O, initial expiratory pressure (EPAP) of 4-8cmH2O. The parameters were adjusted according to the specific conditions of the patients. After 24 hours of treatment, the patient was treated with HFNC until discharge. Patient information was collected during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. PaO2 < 60mmHg, SpO2 < 92%(without oxygen inhalation);
- •Mild to moderate type I respiratory failure (100 mmHg < PaO/Fi02≤300 mmHg);
排除标准
- •Missing primary outcome measures
- •Terminal stage of various chronic diseases;
- •The patient or family members do not agree to NIV or HFNI treatment;
- •Severe type I respiratory failure (PaO2/Fi02≤100 mmHg)
- •Ventilation dysfunction (pH<7.30)
- •Contradictory breathing
- •The patient abandons or terminates treatment, automatically discharges or transfers to another hospital;
- •Serious diseases, such as organ function damage and sepsis;
结局指标
主要结局
height
时间窗: At the time of enrollment in the clinical study
m
eGFR
时间窗: up to 9 days
Estimate glomerular filtration rate in venous blood
Total bilirubin
时间窗: up to 9 days
Serum total bilirubin in venous blood
SO2
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Pulse oxygen saturation
BP
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Blood pressure (Includes systolic and diastolic blood pressure)
HR
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Heart rate
A-aDO2
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Arterial blood K+ concentration
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood K+ concentration
RR
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Respiratory rate
pH
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Degree of pH in arterial blood
GLu
时间窗: On the 4th day after enrollment (On the third day after crossover)
Arterial blood glucose in arterial blood
TCO2
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Total carbon dioxide in arterial blood
age
时间窗: At the time of enrollment in the clinical study
year
PaO2
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Partial arterial oxygen pressure
SaO2
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Arterial oxygen saturation
FiO2
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Fraction of inspiration O2
Glu
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood glucose in arterial blood
RI
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Respiratory Index
Arterial blood Ca2+ concentration
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood Ca2+ concentration
Arterial blood Na+ concentration
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood Na+ concentration
MCV
时间窗: up to 9 days
Mean Corpuscular Volume in venous blood
RDW
时间窗: up to 9 days
red blood cell distribution width in venous blood
NT-proBNP
时间窗: up to 9 days
NT-proBNP in venous blood
ESR
时间窗: up to 9 days
erythrocytesedimentationrate in venous blood
PT
时间窗: up to 9 days
prothrombin time in venous blood
PCO2
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
partial pressure of carbon dioxide in arterial blood
Lac
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Lactic acid in arterial blood
BE
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Base excess in arterial blood
Arterial blood HCO3- concentration
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration
tHbc
时间窗: On the 9th day after enrollment (On the 8th day after crossover)
Total hemoglobin in arterial blood
Weight
时间窗: At the time of enrollment in the clinical study
Kg
WBC
时间窗: up to 9 days
The number of white blood cells in venous blood
LYM
时间窗: up to 9 days
The number of Venous blood lymphocytes in venous blood
MCH
时间窗: up to 9 days
Mean Corpuscular Haemoglobin Concentration in venous blood
D-Di
时间窗: up to 9 days
D-Dimer in venous blood
ALT
时间窗: up to 9 days
alanine transaminase in venous blood
PDW
时间窗: up to 9 days
Platelet distributionwidth in venous blood
CRP
时间窗: up to 9 days
C-reactive protein in venous blood
HCT
时间窗: up to 9 days
hematocrit in venous blood
gender
时间窗: At the time of enrollment in the clinical study
Male and female
NEU
时间窗: up to 9 days
The number of Neutrophil granulocyte in venous blood
BAS
时间窗: up to 9 days
The number of Venous blood Basophils in venous blood
MON
时间窗: up to 9 days
The number of Venous blood Monocyte cell in venous blood
RBC
时间窗: up to 9 days
The number of red blood cells in venous blood
HGB
时间窗: up to 9 days
The number of haemoglobin in venous blood
TP
时间窗: up to 9 days
Total serum protein in venous blood
ALB
时间窗: up to 9 days
Albumin protein in venous blood
GLB
时间窗: up to 9 days
Globulin globulin in venous blood
APTT
时间窗: up to 9 days
activated partial thromboplastin time in venous blood
EOS
时间窗: up to 9 days
The number of Venous blood eosinophils in venous blood
PLT
时间窗: up to 9 days
platelet in venous blood
AST
时间窗: up to 9 days
Aspartate Transaminase in venous blood
PA
时间窗: up to 9 days
Serum prealbumin in venous blood
Cr
时间窗: up to 9 days
creatinine in venous blood
Cys-C
时间窗: up to 9 days
Cystatin C in venous blood
MPV
时间窗: up to 9 days
Mean Platelet Volume in venous blood
plateletcrit
时间窗: up to 9 days
plateletcrit in venous blood
PCT
时间窗: up to 9 days
Procalcitonin in venous blood
TT
时间窗: up to 9 days
Thrombin time in venous blood
BUN
时间窗: up to 9 days
Urea nitrogen in venous blood
Respiratory support time
时间窗: during hospitalization, approximately 9 days
Daily respiratory support time after patients were enrolled in the clinical study，h/Day
Tracheal intubation
时间窗: during hospitalization, approximately 9 days
Yes or No
IBIL
时间窗: up to 9 days
Indirect bilirubin in venous blood
Diaphragm thickness
时间窗: up to 9 days
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Relief time for dyspnea
时间窗: during hospitalization, approximately 9 days
Remission time of dyspnea after intervention
Stay in the ICU
时间窗: during hospitalization, approximately 9 days
Yes or No
Complications
时间窗: during hospitalization, approximately 9 days
Facial injury, flatulence，Gastroesophageal reflux，Dry throat, sore throat，pneumothorax，Eye irritation discomfort，Low blood pressure.
Outcome of disease
时间窗: during hospitalization, approximately 9 days
Get better, get worse, die
DBIL
时间窗: up to 9 days
Direct bilirubin in venous blood
Diaphragm mobility
时间窗: up to 9 days
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
次要结局
- Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort(during hospitalization, approximately 9 days)
- Dyspnea rating scale(during hospitalization, approximately 9 days)
- Patient compliance to the treatment(during hospitalization, approximately 9 days)