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Effects of HFNC on Moderate and Severe Respiratory Failure Patients

Primary Purpose

Respiratory Failure

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

HFNC

NIV

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring HFNC, Respiratory Failure, Intubation, Mortality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intubation rate on 28 days

Arm Description

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

Outcomes

Primary Outcome Measures

intubation rate on 28 days

Secondary Outcome Measures

Duration of ICU stay

Duration of hospital stay

Full Information

NCT ID

NCT02687074

First Posted

January 27, 2016

Last Updated

February 17, 2016

Sponsor

Southeast University, China

Collaborators

First Affiliated Hospital of Suzhou Medical College, Second Affiliated Hospital of Suzhou University, Zhangjiagang First People's Hospital, The Second Hospital of Nanjing Medical University, Wuxi No. 4 People

1. Study Identification

Unique Protocol Identification Number

NCT02687074

Brief Title

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

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southeast University, China

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure

Keywords

HFNC, Respiratory Failure, Intubation, Mortality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intubation rate on 28 days

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

HFNC

Intervention Description

patients treated with high flow nasal cannula

Intervention Type

Device

Intervention Name(s)

NIV

Intervention Description

patients treated with noninvasive ventilation

Primary Outcome Measure Information:

Title

intubation rate on 28 days

Time Frame

up to 28 days

Secondary Outcome Measure Information:

Title

Duration of ICU stay

Time Frame

date of death from any cause, whichever came first, assessed up to 90 days

Title

Duration of hospital stay

Time Frame

date of death from any cause, whichever came first, assessed up to 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials: