Heart FailureHFNONCT03607357
High Flow Nasal Oxygen and Acute Left Heart Failure
A study testing High Flow Nasal Oxygen and Non-invasive Ventilation in people with Heart Failure and Noninvasive Ventilation, run by Nanjing Jiangbei People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Noninvasive Ventilation, Oxygen Therapy
- What is being tested?
- High Flow Nasal Oxygen and Non-invasive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2018to 28 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (1) Chronic Obstructive Pulmonary Disease (COPD)
- (2) Disturbance of consciousness
- (3)Bulbar paralysis, dysphagia
- (4) Facial deformity
- (5) Terminal tumor
- (6) Neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Post-extubation High Flow Nasal Oxygen in Patients With Acute Left Heart Failure: a Clinical Multi-center Study
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.
Read more
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.
Read the detailed description
- 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.
- When passing spontaneous breathing trials and removing tracheal tube, the patients should be divided into two groups by random digital table.
- 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%.
- 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.
- (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.
- Conditions
- Heart Failure, Noninvasive Ventilation, Oxygen Therapy
- Being tested
- High Flow Nasal Oxygen, Non-invasive Ventilation
- Keywords
- High Flow Nasal Oxygen, Non-invasive Ventilation, Acute Left Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%.
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%.
| Study group | Role | What they receive |
|---|---|---|
| HFNO group/Group A | Experimental | The patients should receive the treatment of high flow nasal oxygen immediately after extubation. Receives: Device: High Flow Nasal Oxygen |
| NIV group/Group B | Placebo comparator | The patients should receive the treatment of non-invasive Ventilation immediately after extubation. Receives: Device: Non-invasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-intubation rate within 48 hours
Measured: 48 hours after extubation.
Secondary outcomes (4)
Mortality
Measured: 28 days after joining the study.
Hospitalization time
Measured: From date of randomization to the day when the patient discharges from any cause, assessed up to three months
The length of ICU stay
Measured: From date of randomization to the day when the patient leaves ICU ward, assessed up to three months
blood gas analysis
Measured: on an average of 12 hours, within the range of 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start10 May 2018
- Primary completion26 May 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Jiangbei People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, NanJing PLA 81 Hospital, Nanjing Chest Hospital, Mingji Hospital, Meishan Traditional Chinese Medicine Hospital, Nanjing LuHe People's Hospital, Nanjing Pukou Center Hospital, Thank Inn Chain Hotel Jiangsu Nanjing Lishui People's Hospital, Nanjing Gaochun People's Hospital, The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Sponsor
- Investigators
- Zhenglong Ye, bachelor, Study director, Nanjing Jiangbei People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607357
- Sponsor's protocol ID
- 2018020
- Acronym
- HFNO
- Status last verified
- Apr 2022
- First submitted
- 2 Jul 2018
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post-extubation High Flow Nasal Oxygen in Patients With Acute Left Heart Failure: a Clinical Multi-center Study
- ClinicalTrials.gov ID
- NCT03607357
- Acronym / sponsor ID
- HFNO / 2018020
- Conditions
- Heart Failure, Noninvasive Ventilation, Oxygen Therapy
- Keywords
- High Flow Nasal Oxygen, Non-invasive Ventilation, Acute Left Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Nanjing Jiangbei People's HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, NanJing PLA 81 Hospital, Nanjing Chest Hospital, Mingji Hospital, Meishan Traditional Chinese Medicine Hospital, Nanjing LuHe People's Hospital, Nanjing Pukou Center Hospital, Thank Inn Chain Hotel Jiangsu Nanjing Lishui People's Hospital, Nanjing Gaochun People's Hospital, The First Affiliated Hospital with Nanjing Medical University
- Study start
- 10 May 2018 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- When passing spontaneous breathing trials and removing tracheal tube, the patients should be divided into two groups by random digital table.
- 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%.
- 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.
- (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNO group/Group A | Experimental | Device: High Flow Nasal OxygenThe patients should receive the treatment of high flow nasal oxygen immediately after extubation. |
| NIV group/Group B | Placebo comparator | Device: Non-invasive VentilationThe patients should receive the treatment of non-invasive Ventilation immediately after extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (6 listed)
- (1) Chronic Obstructive Pulmonary Disease (COPD)
- (2) Disturbance of consciousness
- (3)Bulbar paralysis, dysphagia
- (4) Facial deformity
- (5) Terminal tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal OxygenThe 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 | HFNO group/Group A |
| Non-invasive VentilationThe 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%. | Device | NIV group/Group B |
Primary outcome
re-intubation rate within 48 hours
Time frame: 48 hours after extubation.
4 secondary outcomes
Mortality
Time frame: 28 days after joining the study.
Hospitalization time
Time frame: From date of randomization to the day when the patient discharges from any cause, assessed up to three months
The length of ICU stay
Time frame: From date of randomization to the day when the patient leaves ICU ward, assessed up to three months
blood gas analysis
Time frame: on an average of 12 hours, within the range of 48 hours after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenglong Ye, bachelor study director
Nanjing Jiangbei People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Oxygen and Non-invasive Ventilation in people with Heart Failure and Noninvasive Ventilation, run by Nanjing Jiangbei People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-intubation rate within 48 hours (time frame: 48 hours after extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.