Effects of HFNC on Moderate and Severe Respiratory Failure Patients

NCT ID: NCT02687074

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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

Conditions

Respiratory Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intubation rate on 28 days

patients with respiratory failure treat with HFNC or NIV and intubation rate on 28 days

Group Type: EXPERIMENTAL

HFNC

Intervention Type: DEVICE

patients treated with high flow nasal cannula

NIV

Intervention Type: DEVICE

patients treated with noninvasive ventilation

Interventions

HFNC

patients treated with high flow nasal cannula

Intervention Type: DEVICE

NIV

patients treated with noninvasive ventilation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Suzhou Medical College

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Suzhou University

OTHER

Sponsor Role: collaborator

Zhangjiagang First People's Hospital

OTHER

Sponsor Role: collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: collaborator

Wuxi No. 4 People's Hospital

OTHER

Sponsor Role: collaborator

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Chun Pan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chun Pan, Dr

Role: STUDY_CHAIR

Zhongda hospital, Southeast University, Jiangsu, China

Fuxi Sun, Dr

Role: PRINCIPAL_INVESTIGATOR

Nanjing Medical University affiliated Second Hospital

Wei Liu, Dr

Role: PRINCIPAL_INVESTIGATOR

Wuxi Hospital

Jianfeng Xie, Dr

Role: PRINCIPAL_INVESTIGATOR

Suzhou Shili Hospital

Songqiao Liu, Dr

Role: PRINCIPAL_INVESTIGATOR

Suzhou Sencond Hospital

Ling Liu, Dr

Role: PRINCIPAL_INVESTIGATOR

Zhangjiagang Hospital

Other Identifiers

|HFNC study

Identifier Type: -

Identifier Source: org_study_id