Effects of HFNC on Moderate and Severe Respiratory Failure Patients

Study Overview
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Brief Summary
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Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital stay. High flow nasal cannula (HFNC) has advantages of PEEP effects, reducing dead space, increasing EELV and improving comfort, and it has been used to treat respiratory failure patients. In recent study, HFNC could improve mortality of respiratory failure patients with P/F<200mmHg in the subgroup. The investigators want to start a randomized controlled study to evaluate the effects of HFNC on the patients with respiratory failure.

Detailed Description
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just as the brief summary

Official Title
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Effects of High Flow Nasal Canula on Moderate and Severe Respiratory Failure Patients

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: HFNC
* Device: NIV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 years patients met all four of the following criteria: a respiratory rate of more than 25 breaths per minute, a ratio of the partial pressure of arterial oxygen (Pao2) to the Fio2 of 300 mm Hg or less while the patient was breathing oxygen at a flow rate of 10 liters per minute or more for at least 15 minutes, a partial pressure of arterial carbon dioxide (Paco2) not higher than 45 mmHg, and an absence of clinical history of underlying chronic respiratory failure Exclusion Criteria: Paco2 of more than 45 mm Hg exacerbation of asthma or chronic respiratory failure cardiogenic pulmonary edema severe neutropenia hemodynamic instability, use of vasopressors, Glasgow Coma Scale score of 12 points or less (on a scale from 3 to 15, with lower scores indicating reduced levels of consciousness) contraindications to noninvasive ventilation urgent need for endotracheal intubation, a do-not-intubate order, and a decision not to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intubation rate on 28 days<br>patients with respiratory failure treat with HFNC or NIV and intubation rate on 28 days | Device: HFNC<br>* patients treated with high flow nasal cannula<br>Device: NIV<br>* patients treated with noninvasive ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation rate on 28 days |  | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ICU stay |  | date of death from any cause, whichever came first, assessed up to 90 days | 
| Duration of hospital stay |  | date of death from any cause, whichever came first, assessed up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFNC, Respiratory Failure, Intubation, Mortality