Clinical trial NCT02687074: Effects of HFNC on Moderate and Severe Respiratory Failure Patients
Official title: Effects of High Flow Nasal Canula on Moderate and Severe Respiratory Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Keywords: HFNC
Respiratory Failure
Intubation
Mortality
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Suzhou Medical College
name: Second Affiliated Hospital of Suzhou University
name: Zhangjiagang First People's Hospital
name: The Second Hospital of Nanjing Medical University
name: Wuxi No. 4 People
First posted: 2016-02-22
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: intubation rate on 28 days
timeFrame: up to 28 days
Secondary outcomes:
measure: Duration of ICU stay
timeFrame: date of death from any cause, whichever came first, assessed up to 90 days
measure: Duration of hospital stay
timeFrame: date of death from any cause, whichever came first, assessed up to 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Zhongda hospital, Southeast University, Jiangsu, China
name: Chun Pan, Dr
role: STUDY_CHAIR
affiliation: Nanjing Medical University affiliated Second Hospital
name: Fuxi Sun, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuxi Hospital
name: Wei Liu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Suzhou Shili Hospital
name: Jianfeng Xie, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Suzhou Sencond Hospital
name: Songqiao Liu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhangjiagang Hospital
name: Ling Liu, Dr
role: PRINCIPAL_INVESTIGATOR
References: