Clinical trial NCT05784636: Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxemia
Keywords: Hypoxemia, High-flow nasal cannula, Mechanical ventilation
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 243
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: HR
timeFrame: At the time of enrollment in the clinical study
measure: HR
timeFrame: On the first hour after enrollment
measure: HR
timeFrame: On the second hour after enrollment
measure: HR
timeFrame: On the 6th hour after enrollment
measure: HR
timeFrame: On the 12th hour after enrollment
measure: HR
timeFrame: On the 24th hour after enrollment
measure: HR
timeFrame: On the 25th hour after enrollment (On the first hour after crossover)
measure: HR
timeFrame: On the 26th hour after enrollment (On the second hour after crossover)
measure: HR
timeFrame: On the 30th hour after enrollment (On the 6th hour after crossover)
measure: HR
timeFrame: On the 36th hour after enrollment (On the 12th hour after crossover)
measure: HR
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: HR
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: HR
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: HR
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: HR
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: HR
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: HR
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: HR
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: RR
timeFrame: At the time of enrollment in the clinical study
measure: RR
timeFrame: On the first hour after enrollment
measure: RR
timeFrame: On the second hour after enrollment
measure: RR
timeFrame: On the 6th hour after enrollment
measure: RR
timeFrame: On the 12th hour after enrollment
measure: RR
timeFrame: On the 24th hour after enrollment
measure: RR
timeFrame: On the 25th hour after enrollment (On the first hour after crossover)
measure: RR
timeFrame: On the 26th hour after enrollment (On the second hour after crossover)
measure: RR
timeFrame: On the 30th hour after enrollment (On the 6th hour after crossover)
measure: RR
timeFrame: On the 36th hour after enrollment (On the 12th hour after crossover)
measure: RR
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: RR
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: RR
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: RR
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: RR
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: RR
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: RR
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: RR
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: BP
timeFrame: At the time of enrollment in the clinical study
measure: BP
timeFrame: On the first hour after enrollment
measure: BP
timeFrame: On the second hour after enrollment
measure: BP
timeFrame: On the 6th hour after enrollment
measure: BP
timeFrame: On the 12th hour after enrollment
measure: BP
timeFrame: On the 24th hour after enrollment
measure: BP
timeFrame: On the 25th hour after enrollment (On the first hour after crossover)
measure: BP
timeFrame: On the 26th hour after enrollment (On the second hour after crossover)
measure: BP
timeFrame: On the 30th hour after enrollment (On the 6th hour after crossover)
measure: BP
timeFrame: On the 36th hour after enrollment (On the 12th hour after crossover)
measure: BP
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: BP
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: BP
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: BP
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: BP
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: BP
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: BP
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: BP
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: SO2
timeFrame: At the time of enrollment in the clinical study
measure: SO2
timeFrame: On the first hour after enrollment
measure: SO2
timeFrame: On the second hour after enrollment
measure: SO2
timeFrame: On the 6th hour after enrollment
measure: SO2
timeFrame: On the 12th hour after enrollment
measure: SO2
timeFrame: On the 24th hour after enrollment
measure: SO2
timeFrame: On the 25th hour after enrollment (On the first hour after crossover)
measure: SO2
timeFrame: On the 26th hour after enrollment (On the second hour after crossover)
measure: SO2
timeFrame: On the 30th hour after enrollment (On the 6th hour after crossover)
measure: SO2
timeFrame: On the 36th hour after enrollment (On the 12th hour after crossover)
measure: SO2
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: SO2
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: SO2
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: SO2
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: SO2
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: SO2
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: SO2
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: SO2
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: pH
timeFrame: At the time of enrollment in the clinical study
measure: pH
timeFrame: On the 24th hour after enrollment
measure: pH
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: pH
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: pH
timeFrame: On the 4th day after enrollment (On the 3th day after crossover)
measure: pH
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: pH
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: pH
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: pH
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: pH
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: PaO2
timeFrame: At the time of enrollment in the clinical study
measure: PaO2
timeFrame: On the 24th hour after enrollment
measure: PaO2
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: PaO2
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: PaO2
timeFrame: On the 4th day after enrollment (On the 3th day after crossover)
measure: PaO2
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: PaO2
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: PaO2
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: PaO2
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: PaO2
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: SaO2
timeFrame: At the time of enrollment in the clinical study
measure: SaO2
timeFrame: On the 24th hour after enrollment
measure: SaO2
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: SaO2
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: SaO2
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: SaO2
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: SaO2
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: SaO2
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: SaO2
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: SaO2
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: PCO2
timeFrame: At the time of enrollment in the clinical study
measure: PCO2
timeFrame: On the 24th hour after enrollment
measure: PCO2
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: PCO2
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: PCO2
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: PCO2
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: PCO2
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: PCO2
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: PCO2
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: PCO2
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: FiO2
timeFrame: At the time of enrollment in the clinical study
measure: FiO2
timeFrame: On the 24th hour after enrollment
measure: FiO2
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: FiO2
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: FiO2
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: FiO2
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: FiO2
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: FiO2
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: FiO2
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: FiO2
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: Lac
timeFrame: At the time of enrollment in the clinical study
measure: Lac
timeFrame: On the 24th hour after enrollment
measure: Lac
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: Lac
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: Lac
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: Lac
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: Lac
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: Lac
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: Lac
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: Lac
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: Glu
timeFrame: At the time of enrollment in the clinical study
measure: Glu
timeFrame: On the 24th hour after enrollment
measure: Glu
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: Glu
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: GLu
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: Glu
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: Glu
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: Glu
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: Glu
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: Glu
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: A-aDO2
timeFrame: At the time of enrollment in the clinical study
measure: A-aDO2
timeFrame: On the 24th hour after enrollment
measure: A-aDO2
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: A-aDO2
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: A-aDO2
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: A-aDO2
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: A-aDO2
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: A-aDO2
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: A-aDO2
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: A-aDO2
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: BE
timeFrame: At the time of enrollment in the clinical study
measure: BE
timeFrame: On the 24th hour after enrollment
measure: BE
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: BE
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: BE
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: BE
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: BE
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: BE
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: BE
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: BE
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: RI
timeFrame: At the time of enrollment in the clinical study
measure: RI
timeFrame: On the 24th hour after enrollment
measure: RI
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: RI
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: RI
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: RI
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: RI
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: RI
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: RI
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: RI
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: Arterial blood HCO3- concentration
timeFrame: At the time of enrollment in the clinical study
measure: Arterial blood HCO3- concentration
timeFrame: On the 24th hour after enrollment
measure: Arterial blood HCO3- concentration
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: Arterial blood HCO3- concentration
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: Arterial blood HCO3- concentration
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: Arterial blood HCO3- concentration
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: Arterial blood HCO3- concentration
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: Arterial blood HCO3- concentration
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: Arterial blood HCO3- concentration
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: Arterial blood HCO3- concentration
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: Arterial blood K+ concentration
timeFrame: At the time of enrollment in the clinical study
measure: Arterial blood K+ concentration
timeFrame: On the 24th hour after enrollment
measure: Arterial blood K+ concentration
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: Arterial blood K+ concentration
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: Arterial blood K+ concentration
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: Arterial blood K+ concentration
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: Arterial blood K+ concentration
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: Arterial blood K+ concentration
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: Arterial blood K+ concentration
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: Arterial blood K+ concentration
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: Arterial blood Ca2+ concentration
timeFrame: At the time of enrollment in the clinical study
measure: Arterial blood Ca2+ concentration
timeFrame: On the 24th hour after enrollment
measure: Arterial blood Ca2+ concentration
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: Arterial blood Ca2+ concentration
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: Arterial blood Ca2+ concentration
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: Arterial blood Ca2+ concentration
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: Arterial blood Ca2+ concentration
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: Arterial blood Ca2+ concentration
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: Arterial blood Ca2+ concentration
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: Arterial blood Ca2+ concentration
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: Arterial blood Na+ concentration
timeFrame: At the time of enrollment in the clinical study
measure: Arterial blood Na+ concentration
timeFrame: On the 24th hour after enrollment
measure: Arterial blood Na+ concentration
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: Arterial blood Na+ concentration
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: Arterial blood Na+ concentration
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: Arterial blood Na+ concentration
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: Arterial blood Na+ concentration
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: Arterial blood Na+ concentration
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: Arterial blood Na+ concentration
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: Arterial blood Na+ concentration
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: TCO2
timeFrame: At the time of enrollment in the clinical study
measure: TCO2
timeFrame: On the 24th hour after enrollment
measure: TCO2
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: TCO2
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: TCO2
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: TCO2
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: TCO2
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: TCO2
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: TCO2
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: TCO2
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: HCT
timeFrame: At the time of enrollment in the clinical study
measure: HCT
timeFrame: On the 24th hour after enrollment
measure: HCT
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: HCT
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: HCT
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: HCT
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: HCT
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: HCT
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: HCT
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: HCT
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: tHbc
timeFrame: At the time of enrollment in the clinical study
measure: tHbc
timeFrame: On the 24th hour after enrollment
measure: tHbc
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: tHbc
timeFrame: On the third day after enrollment (On the 48th hour after crossover)
measure: tHbc
timeFrame: On the 4th day after enrollment (On the third day after crossover)
measure: tHbc
timeFrame: On the 5th day after enrollment (On the 4th day after crossover)
measure: tHbc
timeFrame: On the 6th day after enrollment (On the 5th day after crossover)
measure: tHbc
timeFrame: On the 7th day after enrollment (On the 6th day after crossover)
measure: tHbc
timeFrame: On the 8th day after enrollment (On the 7th day after crossover)
measure: tHbc
timeFrame: On the 9th day after enrollment (On the 8th day after crossover)
measure: height
timeFrame: At the time of enrollment in the clinical study
measure: Weight
timeFrame: At the time of enrollment in the clinical study
measure: gender
timeFrame: At the time of enrollment in the clinical study
measure: age
timeFrame: At the time of enrollment in the clinical study
measure: WBC
timeFrame: On the first day after enrollment
measure: WBC
timeFrame: up to 9 days
measure: NEU
timeFrame: On the first day after enrollment
measure: NEU
timeFrame: up to 9 days
measure: LYM
timeFrame: On the first day after enrollment
measure: LYM
timeFrame: up to 9 days
measure: EOS
timeFrame: On the first day after enrollment
measure: EOS
timeFrame: up to 9 days
measure: BAS
timeFrame: On the first day after enrollment
measure: BAS
timeFrame: up to 9 days
measure: MON
timeFrame: On the first day after enrollment
measure: MON
timeFrame: up to 9 days
measure: RBC
timeFrame: On the first day after enrollment
measure: RBC
timeFrame: up to 9 days
measure: HGB
timeFrame: On the first day after enrollment
measure: HGB
timeFrame: up to 9 days
measure: HCT
timeFrame: On the first day after enrollment
measure: HCT
timeFrame: up to 9 days
measure: MCV
timeFrame: On the first day after enrollment
measure: MCV
timeFrame: up to 9 days
measure: MCH
timeFrame: On the first day after enrollment
measure: MCH
timeFrame: up to 9 days
measure: RDW
timeFrame: On the first day after enrollment
measure: RDW
timeFrame: up to 9 days
measure: PLT
timeFrame: On the first day after enrollment
measure: PLT
timeFrame: up to 9 days
measure: PDW
timeFrame: On the first day after enrollment
measure: PDW
timeFrame: up to 9 days
measure: MPV
timeFrame: On the first day after enrollment
measure: MPV
timeFrame: up to 9 days
measure: plateletcrit
timeFrame: On the first day after enrollment
measure: plateletcrit
timeFrame: up to 9 days
measure: CRP
timeFrame: On the first day after enrollment
measure: CRP
timeFrame: up to 9 days
measure: PCT
timeFrame: On the first day after enrollment
measure: PCT
timeFrame: up to 9 days
measure: NT-proBNP
timeFrame: On the first day after enrollment
measure: NT-proBNP
timeFrame: up to 9 days
measure: ESR
timeFrame: On the first day after enrollment
measure: ESR
timeFrame: up to 9 days
measure: PT
timeFrame: On the first day after enrollment
measure: PT
timeFrame: up to 9 days
measure: APTT
timeFrame: On the first day after enrollment
measure: APTT
timeFrame: up to 9 days
measure: TT
timeFrame: On the first day after enrollment
measure: TT
timeFrame: up to 9 days
measure: D-Di
timeFrame: On the first day after enrollment
measure: D-Di
timeFrame: up to 9 days
measure: ALT
timeFrame: On the first day after enrollment
measure: ALT
timeFrame: up to 9 days
measure: AST
timeFrame: On the first day after enrollment
measure: AST
timeFrame: up to 9 days
measure: PA
timeFrame: On the first day after enrollment
measure: PA
timeFrame: up to 9 days
measure: TP
timeFrame: On the first day after enrollment
measure: TP
timeFrame: up to 9 days
measure: ALB
timeFrame: On the first day after enrollment
measure: ALB
timeFrame: up to 9 days
measure: GLB
timeFrame: On the first day after enrollment
measure: GLB
timeFrame: up to 9 days
measure: Cr
timeFrame: On the first day after enrollment
measure: Cr
timeFrame: up to 9 days
measure: BUN
timeFrame: On the first day after enrollment
measure: BUN
timeFrame: up to 9 days
measure: Cys-C
timeFrame: On the first day after enrollment
measure: Cys-C
timeFrame: up to 9 days
measure: eGFR
timeFrame: On the first day after enrollment
measure: eGFR
timeFrame: up to 9 days
measure: Respiratory support time
timeFrame: during hospitalization, approximately 9 days
measure: Relief time for dyspnea
timeFrame: during hospitalization, approximately 9 days
measure: Tracheal intubation
timeFrame: during hospitalization, approximately 9 days
measure: Stay in the ICU
timeFrame: during hospitalization, approximately 9 days
measure: Complications
timeFrame: during hospitalization, approximately 9 days
measure: Outcome of disease
timeFrame: during hospitalization, approximately 9 days
measure: Total bilirubin
timeFrame: On the first day after enrollment
measure: Total bilirubin
timeFrame: up to 9 days
measure: DBIL
timeFrame: On the first day after enrollment
measure: DBIL
timeFrame: up to 9 days
measure: IBIL
timeFrame: On the first day after enrollment
measure: IBIL
timeFrame: up to 9 days
measure: Diaphragm mobility
timeFrame: At the time of enrollment in the clinical study
measure: Diaphragm mobility
timeFrame: On the 24th hour after enrollment
measure: Diaphragm mobility
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: Diaphragm mobility
timeFrame: up to 9 days
measure: Diaphragm thickness
timeFrame: At the time of enrollment in the clinical study
measure: Diaphragm thickness
timeFrame: On the 24th hour after enrollment
measure: Diaphragm thickness
timeFrame: On the 48th hour after enrollment (On the 24th hour after crossover)
measure: Diaphragm thickness
timeFrame: up to 9 days
Secondary outcomes:
measure: Patient compliance to the treatment
timeFrame: during hospitalization, approximately 9 days
measure: Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort
timeFrame: during hospitalization, approximately 9 days
measure: Dyspnea rating scale
timeFrame: during hospitalization, approximately 9 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Dedong Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.
citation: Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.
citation: Chen BX, Ou Q, Pan MX. [A cross-sectional survey of treatment acceptance and influence factors in patients with obstructive sleep apnea]. Zhonghua Yi Xue Za Zhi. 2018 May 29;98(20):1578-1581. doi: 10.3760/cma.j.issn.0376-2491.2018.20.010. Chinese.