Hypoxemia
Conditions
Keywords
Hypoxemia, High-flow nasal cannula, Mechanical ventilation
Brief summary
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.
Detailed description
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.
Interventions
DEVICENon-invasive BiPAP ventilation
Patients were first treated with HFNC (High-flow nasal cannula) on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40l /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.
DEVICEHFNC
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 (High-flow nasal cannula) until discharge.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. . PaO2 \< 60mmHg, SpO2 \< 92%(without oxygen inhalation); 2. Mild to moderate type I respiratory failure (100 mmHg \< PaO/Fi02≤300 mmHg);
Exclusion criteria
1. Missing primary outcome measures 2. Terminal stage of various chronic diseases; 3. The patient or family members do not agree to NIV or HFNI treatment; 4. Severe type I respiratory failure (PaO2/Fi02≤100 mmHg) 5. Ventilation dysfunction (pH\<7.30) 6. Contradictory breathing 7. The patient abandons or terminates treatment, automatically discharges or transfers to another hospital; 8. Serious diseases, such as organ function damage and sepsis;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragm thickness | At the time of enrollment in the clinical study | 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. |
| BUN | On the first day after enrollment | Urea nitrogen in venous blood |
| Cys-C | On the first day after enrollment | Cystatin C in venous blood |
| Stay in the ICU | during hospitalization, approximately 9 days | Yes or No |
| IBIL | On the first day after enrollment | Indirect bilirubin in venous blood |
| Diaphragm mobility | At the time of enrollment in the clinical study | 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. |
| Cr | On the first day after enrollment | creatinine in venous blood |
| eGFR | On the first day after enrollment | Estimate glomerular filtration rate in venous blood |
| Respiratory support time | during hospitalization, approximately 9 days | Daily respiratory support time after patients were enrolled in the clinical study，h/Day |
| Relief time for dyspnea | during hospitalization, approximately 9 days | Remission time of dyspnea after intervention |
| Tracheal intubation | during hospitalization, approximately 9 days | Yes or No |
| PaO2 | At the time of enrollment in the clinical study | Partial arterial oxygen pressure |
| AST | On the first day after enrollment | Aspartate Transaminase in venous blood |
| PA | On the first day after enrollment | Serum prealbumin in venous blood |
| TP | On the first day after enrollment | Total serum protein in venous blood |
| HR | At the time of enrollment in the clinical study | Heart rate |
| RR | At the time of enrollment in the clinical study | Respiratory rate |
| BP | At the time of enrollment in the clinical study | Blood pressure (Includes systolic and diastolic blood pressure) |
| SO2 | At the time of enrollment in the clinical study | Pulse oxygen saturation |
| pH | At the time of enrollment in the clinical study | Degree of pH in arterial blood |
| SaO2 | At the time of enrollment in the clinical study | Arterial oxygen saturation |
| PCO2 | At the time of enrollment in the clinical study | partial pressure of carbon dioxide in arterial blood |
| FiO2 | At the time of enrollment in the clinical study | Fraction of inspiration O2 |
| Lac | At the time of enrollment in the clinical study | Lactic acid in arterial blood |
| Glu | At the time of enrollment in the clinical study | Arterial blood glucose in arterial blood |
| GLu | On the 4th day after enrollment (On the third day after crossover) | Arterial blood glucose in arterial blood |
| A-aDO2 | At the time of enrollment in the clinical study | The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood |
| BE | At the time of enrollment in the clinical study | Base excess in arterial blood |
| RI | At the time of enrollment in the clinical study | Respiratory Index |
| Arterial blood HCO3- concentration | At the time of enrollment in the clinical study | Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration |
| Arterial blood K+ concentration | At the time of enrollment in the clinical study | Arterial blood K+ concentration |
| Arterial blood Ca2+ concentration | At the time of enrollment in the clinical study | Arterial blood Ca2+ concentration |
| ALB | On the first day after enrollment | Albumin protein in venous blood |
| GLB | On the first day after enrollment | Globulin globulin in venous blood |
| Arterial blood Na+ concentration | At the time of enrollment in the clinical study | Arterial blood Na+ concentration |
| TCO2 | At the time of enrollment in the clinical study | Total carbon dioxide in arterial blood |
| HCT | At the time of enrollment in the clinical study | hematocrit in arterial blood |
| tHbc | At the time of enrollment in the clinical study | Total hemoglobin in arterial blood |
| height | At the time of enrollment in the clinical study | m |
| Weight | At the time of enrollment in the clinical study | Kg |
| gender | At the time of enrollment in the clinical study | Male and female |
| age | At the time of enrollment in the clinical study | year |
| WBC | On the first day after enrollment | The number of white blood cells in venous blood |
| NEU | On the first day after enrollment | The number of Neutrophil granulocyte in venous blood |
| LYM | On the first day after enrollment | The number of Venous blood lymphocytes in venous blood |
| EOS | On the first day after enrollment | The number of Venous blood eosinophils in venous blood |
| BAS | On the first day after enrollment | The number of Venous blood Basophils in venous blood |
| MON | On the first day after enrollment | The number of Venous blood Monocyte cell in venous blood |
| RBC | On the first day after enrollment | The number of red blood cells in venous blood |
| HGB | On the first day after enrollment | The number of haemoglobin in venous blood |
| MCV | On the first day after enrollment | Mean Corpuscular Volume in venous blood |
| MCH | On the first day after enrollment | Mean Corpuscular Haemoglobin Concentration in venous blood |
| RDW | On the first day after enrollment | red blood cell distribution width in venous blood |
| PLT | On the first day after enrollment | platelet in venous blood |
| PDW | On the first day after enrollment | Platelet distributionwidth in venous blood |
| MPV | On the first day after enrollment | Mean Platelet Volume in venous blood |
| plateletcrit | On the first day after enrollment | plateletcrit in venous blood |
| CRP | On the first day after enrollment | C-reactive protein in venous blood |
| PCT | On the first day after enrollment | Procalcitonin in venous blood |
| NT-proBNP | On the first day after enrollment | NT-proBNP in venous blood |
| ESR | On the first day after enrollment | erythrocytesedimentationrate in venous blood |
| PT | On the first day after enrollment | prothrombin time in venous blood |
| APTT | On the first day after enrollment | activated partial thromboplastin time in venous blood |
| TT | On the first day after enrollment | Thrombin time in venous blood |
| D-Di | On the first day after enrollment | D-Dimer in venous blood |
| ALT | On the first day after enrollment | alanine transaminase in venous blood |
| Complications | during hospitalization, approximately 9 days | Facial injury, flatulence，Gastroesophageal reflux，Dry throat, sore throat，pneumothorax，Eye irritation discomfort，Low blood pressure. |
| Outcome of disease | during hospitalization, approximately 9 days | Get better, get worse, die |
| Total bilirubin | On the first day after enrollment | Serum total bilirubin in venous blood |
| DBIL | On the first day after enrollment | Direct bilirubin in venous blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient compliance to the treatment | during hospitalization, approximately 9 days | Patients were managed for compliance with the treatment.Dependent judgment 1. Complete dependence: patients actively cooperate with medical staff in treatment 2. Partial dependence: in most cases, patients can cooperate with the treatment, and in a few cases, patients resist the treatment but receive treatment after being enlightened by the medical staff. 3. Non-dependence: patients have strong resistance and resistance, so that they are unable to use ventilators or nasal high-flow humidification instruments. |
| Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort | during hospitalization, approximately 9 days | Kolcaba's General Comfort Questionnaire (GCQ) is composed of 28 items from 4 dimensions: physiological, psychological, spiritual, socio-cultural and environmental. The modification Scale adopts 1 to 4Likert Scale, with 1 indicating strongly disagree and 4 indicating strongly agree. In the negative question, 1 means strongly agree and 4 means strongly disagree. A higher score indicates more comfort. |
| Dyspnea rating scale | during hospitalization, approximately 9 days | According to the degree of dyspnea and symptoms of the patient, the lowest score is 0, the highest score is 10. |
Countries
China
Contacts
Primary ContactDedong Ma, MD
Backup Contactchunwei He, master
Outcome results
None listed