NCT05784636

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxemia

Interventions

Type	Name	Description
DEVICE	Non-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.
DEVICE	HFNC	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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-06-01
• Completion: 2024-06-06
• First posted: 2023-03-27
• Last updated: 2023-03-27

Locations

1 site across 1 country: China