Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03607357 |
| Other study ID # |
2018020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2018 |
| Est. completion date |
June 28, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Nanjing Jiangbei People's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1. The anticipated number of patient subjects will reach 120 in the study. The patient's
condition should be informed to his/her next of kin and then agree to signs the informed
consent.
2. When passing spontaneous breathing trials and removing tracheal tube, the patients
should be divided into two groups by random digital table.
3. Group A/HFNO group: the patients should receive the treatment of high flow nasal oxygen
immediately after extubation. The initial flow speed was set at 30L/min and increased at
5L/min in titrated type until the patient feels uncomfortable. The temperature was set
at 37℃. The fraction of inspiration O2 was set in accordance with specific condition of
patient to insure oxygen saturation more than 95%.
Group B/NIV group: the patients should receive the treatment of non-invasive ventilation
immediately after extubation. The 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 was set in accordance with specific condition
of patient to insure oxygen saturation more than 95%.
4. The criteria of successful extubation: the patient doesn't require re-intubation within
48 hours after extubation.
The criteria of extubation failure: the patient needs re-intubation and ventilation
support within 48 hours after extubation.
5. (1) Investigators should keep a record of these patient's general condition, for
instance, age, sex, diagnosis, Apache II score, treatment, etc.(2) Investigators should
routinely detect clinical manifestation, ventilation parameters and physiological
indices of the recruited patients. Elementary monitoring indicators consist of vital
signs, oxygen saturation, ECG, tidal volume, breathing rate, inspiratory pressure,
expiratory pressure and blood gas analysis. Blood gas analysis should be evaluated on an
average of 12 hours, within the range of 48 hours after extubation.(3) Clinical
prognosis of these patients should be recorded, including the rate of weaning failure,
re-intubation rate, time for re-intubation, causes of re-intubation, duration of
HFNO/HIV, length of ICU stay, hospitalization time and number of death.（4） The data of
adverse effect derived from devices applied in the study should be recorded. HFNO group:
dry nasal cavity, dry oropharyngeal cavity, dysphagia.HIV group: 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.
