Effects of HFNC on Moderate and Severe Respiratory Failure Patients

Not Applicable

• Conditions: Respiratory Failure
• Interventions: Device: HFNC; Device: NIV

• Registration Number: NCT02687074
• Lead Sponsor: Southeast University, China

Brief Summary

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

just as the brief summary

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-27
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

1. Age>18 years

2. 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

1. Paco2 of more than 45 mm Hg
2. exacerbation of asthma or chronic respiratory failure
3. cardiogenic pulmonary edema
4. severe neutropenia
5. hemodynamic instability, use of vasopressors,
6. Glasgow Coma Scale score of 12 points or less (on a scale from 3 to 15, with lower scores indicating reduced levels of consciousness)
7. contraindications to noninvasive ventilation
8. urgent need for endotracheal intubation, a do-not-intubate order, and a decision not to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intubation rate on 28 days	HFNC	patients with respiratory failure treat with HFNC or NIV and intubation rate on 28 days
Intubation rate on 28 days	NIV	patients with respiratory failure treat with HFNC or NIV and intubation rate on 28 days

Primary Outcome Measures

Name	Time	Method
intubation rate on 28 days	up to 28 days

Secondary Outcome Measures

Name	Time	Method
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