Effects of HFNC on Moderate and Severe Respiratory Failure Patients

Respiratory Failure Clinical Trial

Official title:

Effects of High Flow Nasal Canula on Moderate and Severe Respiratory Failure Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02687074
• Other study ID #: |HFNC study
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 27, 2016
• Last updated: February 17, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Jiangsu Province Health Department
• Study type: Interventional

Clinical Trial 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.

Description:

just as the brief summary

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 246
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Southeast University, China	First Affiliated Hospital of Suzhou Medical College, Second Affiliated Hospital of Suzhou University, The Second Hospital of Nanjing Medical University, Wuxi No. 4 People, Zhangjiagang First People

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intubation rate on 28 days		up to 28 days	No
Secondary	Duration of ICU stay		date of death from any cause, whichever came first, assessed up to 90 days	No
Secondary	Duration of hospital stay		date of death from any cause, whichever came first, assessed up to 90 days	No