Effects of HFNC on Moderate and Severe Respiratory Failure Patients

NCT02687074 | Unknown DMC

• 1 other identifier: |HFNC study
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Failure

Keywords

HFNC; Respiratory Failure; Intubation; Mortality

Outcome Measures

Primary Outcomes (1)

• intubation rate on 28 days

  up to 28 days

Secondary Outcomes (2)

• 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

Study Arms (1)

Intubation rate on 28 days

EXPERIMENTAL

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

Device: HFNC; Device: NIV

Interventions

HFNC DEVICE

patients treated with high flow nasal cannula

Intubation rate on 28 days

NIV DEVICE

patients treated with noninvasive ventilation

Intubation rate on 28 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead
• First Affiliated Hospital of Suzhou Medical College: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator
• Zhangjiagang First People's Hospital: collaborator
• The Second Hospital of Nanjing Medical University: collaborator
• Wuxi No. 4 People's Hospital: collaborator

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Chun Pan, Dr

  Zhongda hospital, Southeast University, Jiangsu, China

  STUDY CHAIR

• Fuxi Sun, Dr

  Nanjing Medical University affiliated Second Hospital

  PRINCIPAL INVESTIGATOR

• Wei Liu, Dr

  Wuxi Hospital

  PRINCIPAL INVESTIGATOR

• Jianfeng Xie, Dr

  Suzhou Shili Hospital

  PRINCIPAL INVESTIGATOR

• Songqiao Liu, Dr

  Suzhou Sencond Hospital

  PRINCIPAL INVESTIGATOR

• Ling Liu, Dr

  Zhangjiagang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 22, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 22, 2016

Record last verified: 2016-02