High Flow Nasal Oxygen and Acute Left Heart Failure

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.

Conditions

• Heart Failure
• Noninvasive Ventilation
• Oxygen Therapy

Interventions

DEVICE

High Flow Nasal Oxygen

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%.

DEVICE

Non-invasive Ventilation

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%.

Sponsors & Collaborators

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Jiangsu Province Hospital of Traditional Chinese Medicine

  collaborator OTHER

• NanJing PLA 81 Hospital

  collaborator OTHER

• Nanjing Chest Hospital

  collaborator UNKNOWN

• Mingji Hospital

  collaborator OTHER

• Meishan Traditional Chinese Medicine Hospital

  collaborator OTHER

• Nanjing LuHe People's Hospital

  collaborator UNKNOWN

• Nanjing Pukou Center Hospital

  collaborator OTHER

• Thank Inn Chain Hotel Jiangsu Nanjing Lishui People's Hospital

  collaborator OTHER

• Nanjing Gaochun People's Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Nanjing Jiangbei People's Hospital

  lead OTHER

Principal Investigators

• Zhenglong Ye, bachelor · Nanjing Jiangbei People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-10

Primary Completion

2021-05-26

Completion

2021-06-28

Countries

• China

Study Locations