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

Shandong University

Status: Not yet enrolling

Conditions: Hypoxemia

Treatments: Device: Non-invasive BiPAP ventilation; Device: HFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT05784636

2022039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 243 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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243 participants in 2 patient groups

Non-invasive BiPAP ventilation treatment group

Experimental group

Description:

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

Treatment:

Device: Non-invasive BiPAP ventilation

Device: HFNC

HFNC treatment group

Experimental group

Description:

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.

Treatment:

Device: Non-invasive BiPAP ventilation

Device: HFNC