Effects of HFNC on Moderate and Severe Respiratory Failure Patients

Overview

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.

Full Title of Study: “Effects of High Flow Nasal Canula on Moderate and Severe Respiratory Failure Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

Detailed Description

just as the brief summary

Interventions

  • Device: HFNC
    • patients treated with high flow nasal cannula
  • Device: NIV
    • patients treated with noninvasive ventilation

Arms, Groups and Cohorts

  • Experimental: Intubation rate on 28 days
    • patients with respiratory failure treat with HFNC or NIV and intubation rate on 28 days

Clinical Trial Outcome Measures

Primary Measures

  • intubation rate on 28 days
    • Time Frame: up to 28 days

Secondary Measures

  • Duration of ICU stay
    • Time Frame: date of death from any cause, whichever came first, assessed up to 90 days
  • Duration of hospital stay
    • Time Frame: date of death from any cause, whichever came first, assessed up to 90 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Southeast University, China
  • Collaborator
    • First Affiliated Hospital of Suzhou Medical College
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chun Pan, Principal Investigator – Southeast University, China
  • Overall Official(s)
    • Chun Pan, Dr, Study Chair, Zhongda hospital, Southeast University, Jiangsu, China
    • Fuxi Sun, Dr, Principal Investigator, Nanjing Medical University affiliated Second Hospital
    • Wei Liu, Dr, Principal Investigator, Wuxi Hospital
    • Jianfeng Xie, Dr, Principal Investigator, Suzhou Shili Hospital
    • Songqiao Liu, Dr, Principal Investigator, Suzhou Sencond Hospital
    • Ling Liu, Dr, Principal Investigator, Zhangjiagang Hospital

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