Comparison of PEEP in Acute Decompensated Heart Failure

Heart Decompensation Clinical Trial

Official title:

Comparison of High VErsus Low Positive End-Expiratory Pressure in Mechanically Ventilated Patients With Acute Heart Failure (HELP-AFH) : Open-label Randomized Controlled Multi-center Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04853563
• Other study ID #: AMC_2021_0433
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2022
• Source: Asan Medical Center
• Contact: Minseok Kim
• Phone: (82-2)-3010-3948
• Email: msk[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Little is known about optimal level of positive end-expiratory pressure (PEEP) in patiens who recieved invasive mechanical ventilation for acute decompensated heart failure. We therefore sought to compare clinical outcome according to low versus high PEEP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Subject who was diagnosed with congestive heart failure and objective evidence of pulmonary congestion (pulmonary edema on simple chest radiography or positive B-line on lung ultrasonography AND elevated B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide level) as a reason for invasive mechanical ventilation

2. Age over 19 years old

3. Subject who agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the clinical site.

Exclusion Criteria:

1. Subject who are on mechanical circulatory support (ECMO, intra-aortic balloon pump, VAD) at the time of randomization

2. Subject who has cardiac abnormality that requires emergent or urgent percutaneous or surgical valvular procedure

3. Subject who are on vasoactive or inotropic agents at least moderate dose defined as vasoactive-inotropic score >10

4. Isolated preload-dependent cardiac dysfunction (isolated right ventricular failure, right ventricular infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction)

5. Predominant right ventricular failure defined as following; clinical evidence of right ventricular failure by attending physician's discretion including hepatojugular reflux, Kussmaul sign, cardiac liver cirrhosis, hepato/splenomegaly, acites, thronmbocytopenia, etc.

6. Subject who are not on mechanical ventilation before open heart surgery

7. Subject who received unwitness cardiopulmonary rescucitation (CPR) or witness CPR lasting more than 30 minutes

8. Subject who was already diagnosed or is suspected to have hypertophic cardiomyopathy with significant left ventricular outflow tract (LVOT) obstruction

9. Subject with intracranial hemorrahge or ischemic stroke at the time of randomization

10. Subject with irreversible neurologic damage or irreversible hepatic failure

11. Invasive mechanical ventilation lasting more than 24 hours preceding endotracheal intubation

12. Subject with underlying chronic obstructive pulmonary disease (GOLD classification III or IV) or restrictive pulmonary disease (e.g. interstitial lung disease)

13. Subject with impaired consciousness that can not perform self coughing and need suction to maintain adequate airway patency

14. Pregnant and/or lactating women

15. Subject with life expectancy less than a year

16. Subject who is not suitable to enrollment by investigator's discretion

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure
• Mechanical Ventilation Pressure High

Intervention

Other:
• PEEP
High PEEP targeted to 10 cmH2O to be maintained during the period of mechanical ventilation compared with low PEEP maintaining 3-5 cmH2O

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free day at 28-day	Starting at the day of randomization, and the days on non-invasive ventilation do not count. Successful extubation is defined as at least 24 hours wihtout reintubation independent of invasive assisted ventilation in survivor. Non-survivor within 28 days: ventilator-free day counted as 0, ventilator-free day among only survivor at 28-day will be counted for primary endpoint.	up to 28-day