Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Qilu Hospital of Shandong University243 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Interventions

Non-invasive BiPAP ventilationDEVICE

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.

HFNCDEVICE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Heart rate

Time frame: At the time of enrollment in the clinical study

Heart rate

Time frame: On the first hour after enrollment

Heart rate

Time frame: On the second hour after enrollment

Heart rate

Time frame: On the 6th hour after enrollment

Heart rate

Time frame: On the 12th hour after enrollment

Heart rate

Time frame: On the 24th hour after enrollment

Heart rate

Time frame: On the 25th hour after enrollment (On the first hour after crossover)

Heart rate

Time frame: On the 26th hour after enrollment (On the second hour after crossover)

Heart rate

Time frame: On the 30th hour after enrollment (On the 6th hour after crossover)

Heart rate

Time frame: On the 36th hour after enrollment (On the 12th hour after crossover)

Heart rate

Time frame: On the 48th hour after enrollment (On the 24th hour after crossover)

Heart rate

Time frame: On the third day after enrollment (On the 48th hour after crossover)

Heart rate

Time frame: On the 4th day after enrollment (On the third day after crossover)

Heart rate

Time frame: On the 5th day after enrollment (On the 4th day after crossover)

Heart rate

Time frame: On the 6th day after enrollment (On the 5th day after crossover)

Heart rate

Time frame: On the 7th day after enrollment (On the 6th day after crossover)

Heart rate

Time frame: On the 8th day after enrollment (On the 7th day after crossover)

Heart rate

Time frame: On the 9th day after enrollment (On the 8th day after crossover)

Respiratory rate

Time frame: At the time of enrollment in the clinical study

Respiratory rate

Time frame: On the first hour after enrollment

Respiratory rate

Time frame: On the second hour after enrollment

Respiratory rate

Time frame: On the 6th hour after enrollment

Respiratory rate

Time frame: On the 12th hour after enrollment

Respiratory rate

Time frame: On the 24th hour after enrollment

Respiratory rate

Time frame: On the 25th hour after enrollment (On the first hour after crossover)

Respiratory rate

Time frame: On the 26th hour after enrollment (On the second hour after crossover)

Respiratory rate

Time frame: On the 30th hour after enrollment (On the 6th hour after crossover)

Respiratory rate

Time frame: On the 36th hour after enrollment (On the 12th hour after crossover)

Respiratory rate

Time frame: On the 48th hour after enrollment (On the 24th hour after crossover)

Respiratory rate

Time frame: On the third day after enrollment (On the 48th hour after crossover)

Respiratory rate

Time frame: On the 4th day after enrollment (On the third day after crossover)

Respiratory rate

Time frame: On the 5th day after enrollment (On the 4th day after crossover)

Respiratory rate

Time frame: On the 6th day after enrollment (On the 5th day after crossover)

Respiratory rate

Time frame: On the 7th day after enrollment (On the 6th day after crossover)

Respiratory rate

Time frame: On the 8th day after enrollment (On the 7th day after crossover)

Respiratory rate

Time frame: On the 9th day after enrollment (On the 8th day after crossover)

Blood pressure (Includes systolic and diastolic blood pressure)