NCT03607357

Brief Summary

Acute left heart failure (ALHF) is a sudden attack or deterioration of abnormal left heart function, which may impair myocardial contractility and increase cardiac loading, further result in decreased cardiac output, abrupt elevation of pulmonary and systemic circulation pressure, consequently trigger in acute pulmonary congestion, acute pulmonary edema and cardiac shock . Hypoxia and severe dyspnea may pose fatal threats for the patients suffered from ALHF should be alleviated as soon as possible, and thus oxygen therapy and ventilation support are regarded as important therapeutic measures for these patients. According to 2017 Chinese College of Emergency Physicians(CCEP) acute heart failure clinical guideline, invasive ventilation should be recommended to those patients whose symptoms still get worsening despite timely treatments. Intubation may increase the risks of infection and multiple organ failure, so timely extubation contributes to reduce the duration of mechanical ventilation and the rate of complications. But if extubation failure occurs, the patient often requires re-intubation that may induce the outset of complications, extend the length of stay and increase mortality. Heart failure proves to be high risk factor for extubation failure on the basis of previous studies. It is recommended to apply sequential non-invasive ventilation (NIV) if the patient receiving invasive ventilation for more than 24 hours and having high risk for extubation failure on the basis of 2017 American Thoracic Society(ATS) clinical guideline. It is worthy to note that NIV has many shortcomings, for example, it may induce dry oropharyngeal cavity, skin injury caused by mask oppression, gaseous distention, vomiting, respiratory aspiration, air leak, drying sputum, difficulty in coughing up phlegm and claustrophobia. As an emerging technology, high flow nasal oxygen (HFNO) has many advantages in airway humidification, tolerance and compliance which also can effectively improve pulmonary oxygenation function of patients with respiratory failure. Which therapeutic measure should be recommended for the patients with ALHF after extubation, NIV or HFNO? It is still unclear according to the latest management guidelines. So one perspective study will be launch to compare the difference between HFNO-group patients with NIV-group patients in re-intubation rate within 48 hours, oxygenation index, length of ICU stay, total hospital stay, mortality and compliance for evidence-based medicine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started May 2018

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

July 2, 2018

Last Update Submit

April 7, 2022

Conditions

Heart FailureNoninvasive VentilationOxygen Therapy

Keywords

High Flow Nasal OxygenNon-invasive VentilationAcute Left Heart Failure

Outcome Measures

Primary Outcomes (1)

  • re-intubation rate within 48 hours

    48 hours after extubation.

Secondary Outcomes (4)

  • Mortality

    28 days after joining the study.

  • Hospitalization time

    From date of randomization to the day when the patient discharges from any cause, assessed up to three months

  • The length of ICU stay

    From date of randomization to the day when the patient leaves ICU ward, assessed up to three months

  • blood gas analysis

    on an average of 12 hours, within the range of 48 hours after extubation

Study Arms (2)

HFNO group/Group A

EXPERIMENTAL

The patients should receive the treatment of high flow nasal oxygen immediately after extubation.

Device: High Flow Nasal Oxygen

NIV group/Group B

PLACEBO COMPARATOR

The patients should receive the treatment of non-invasive Ventilation immediately after extubation.

Device: Non-invasive Ventilation

Interventions

High Flow Nasal OxygenDEVICE

The initial flow speed is set at 30L/min and increases at 5L/min in titrated type until the patient feels uncomfortable. The temperature is set at 37℃. The fraction of inspiration O2 is set in accordance with specific condition of patient to insure oxygen saturation more than 95%.

HFNO group/Group A
Non-invasive VentilationDEVICE

The values of initial pressure are set at a lower level (inspiratory pressure: 6-8cmH2O, expiratory pressure: 4cmH2O) and adjusted to a suitable level in 10-20min. The fraction of inspiration O2 is set in accordance with specific condition of patient to insure oxygen saturation more than 95%.

NIV group/Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) Clinical diagnosis of acute left heart failure
  • (2) The patient receives invasive ventilation for more than 24 hours
  • (3) Must pass spontaneous breathing trials
  • (4) Patient's next of kin agrees to sign the informed consent.

You may not qualify if:

  • (1) Chronic Obstructive Pulmonary Disease (COPD)
  • (2) Disturbance of consciousness
  • (3)Bulbar paralysis, dysphagia
  • (4) Facial deformity
  • (5) Terminal tumor
  • (6) Neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Jiangbei People's Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Zhenglong Ye, bachelor

    Nanjing Jiangbei People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 31, 2018

Study Start

May 10, 2018

Primary Completion

May 26, 2021

Study Completion

June 28, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

CN(1)