临床试验/NCT05784636

NCT05784636尚未招募不适用

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

Qilu Hospital of Shandong University1 个研究点分布在 1 个国家目标入组 243 人开始时间: 2023年3月1日最近更新: 2023年3月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Qilu Hospital of Shandong University
入组人数: 243
试验地点: 1
主要终点: SO2

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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;

研究组 & 干预措施

Non-invasive BiPAP ventilation treatment group

Experimental

Patients were first treated with HFNC on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40 L/min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge

干预措施: Non-invasive BiPAP ventilation (Device)

Non-invasive BiPAP ventilation treatment group

Experimental

干预措施: HFNC (Device)

HFNC treatment group

Experimental

On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC until discharge.

干预措施: Non-invasive BiPAP ventilation (Device)

HFNC treatment group

Experimental

干预措施: HFNC (Device)

结局指标

主要结局

SO2

时间窗: On the 9th day after enrollment (On the 8th day after crossover)

Pulse oxygen saturation

PLT

时间窗: up to 9 days

platelet in venous blood

height

时间窗: At the time of enrollment in the clinical study

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

时间窗: up to 9 days

Thrombin time in venous blood

时间窗: On the 9th day after enrollment (On the 8th day after crossover)

Blood pressure (Includes systolic and diastolic blood pressure)

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

时间窗: On the 9th day after enrollment (On the 8th day after crossover)

Respiratory rate

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

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

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

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

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

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

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

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

AST

时间窗: up to 9 days

Aspartate Transaminase in venous blood

时间窗: up to 9 days

Serum prealbumin in venous blood

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

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.

时间窗: On the first hour after enrollment

Heart rate

PCT

时间窗: On the first day after enrollment

Procalcitonin in venous blood

时间窗: On the second hour after enrollment

Heart rate

时间窗: On the 6th hour after enrollment

Heart rate

NT-proBNP

时间窗: On the first day after enrollment

NT-proBNP in venous blood

时间窗: On the 12th hour after enrollment

Heart rate

时间窗: At the time of enrollment in the clinical study

Heart rate

时间窗: On the 24th hour after enrollment

Heart rate

时间窗: On the 25th hour after enrollment (On the first hour after crossover)

Heart rate

时间窗: On the 26th hour after enrollment (On the second hour after crossover)

Heart rate

时间窗: On the 30th hour after enrollment (On the 6th hour after crossover)

Heart rate

时间窗: On the 36th hour after enrollment (On the 12th hour after crossover)

Heart rate

时间窗: On the 48th hour after enrollment (On the 24th hour after crossover)

Heart rate

时间窗: On the third day after enrollment (On the 48th hour after crossover)

Heart rate

时间窗: On the 4th day after enrollment (On the third day after crossover)

Heart rate

时间窗: On the 5th day after enrollment (On the 4th day after crossover)

Heart rate

时间窗: On the 6th day after enrollment (On the 5th day after crossover)

Heart rate

时间窗: On the 7th day after enrollment (On the 6th day after crossover)

Heart rate

时间窗: On the 8th day after enrollment (On the 7th day after crossover)