Effects of HFNC on Moderate and Severe Respiratory Failure Patients

February 17, 2016 updated by: Chun Pan, Southeast University, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

just as the brief summary

Study Type

Interventional

Enrollment (Anticipated)

246

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intubation rate on 28 days
patients with respiratory failure treat with HFNC or NIV and intubation rate on 28 days
Device: HFNC
patients treated with high flow nasal cannula
Device: NIV
patients treated with noninvasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intubation rate on 28 days
Time Frame: up to 28 days
up to 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of ICU stay
Time Frame: date of death from any cause, whichever came first, assessed up to 90 days
date of death from any cause, whichever came first, assessed up to 90 days
Duration of hospital stay
Time Frame: date of death from any cause, whichever came first, assessed up to 90 days
date of death from any cause, whichever came first, assessed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Collaborators

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

Investigators

  • Study Chair: Chun Pan, Dr, Zhongda hospital, Southeast University, Jiangsu, China
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • |HFNC study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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