Comparison of PEEP in Acute Decompensated Heart Failure

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

Sponsors

Lead Sponsor: Asan Medical Center

Source Asan Medical Center
Brief 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.

Overall Status Recruiting
Start Date 2021-04-20
Completion Date 2024-04-30
Primary Completion Date 2023-07-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Ventilator-free day at 28-day up to 28-day
Enrollment 120
Condition
Intervention

Intervention Type: Other

Intervention Name: PEEP

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

Eligibility

Criteria:

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 BNP or NT-proBNP 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, IABP, 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 RV failure, RV infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction) 5. Predominant RV failure defined as following; clinical evidence of RV 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 12 hours preceding ICU admission 12. Subject with underlying COPD (COLD 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

Gender:

All

Minimum Age:

19 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Minseok Kim

Phone: (82-2)-3010-3948

Email: [email protected]

Location
Facility: Status: Contact: Asan Medical Center Min Seok Kim, PhD 02-3010-3948 [email protected]
Location Countries

Korea, Republic of

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Asan Medical Center

Investigator Full Name: Min-Seok Kim

Investigator Title: professor of medicine

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: High PEEP

Type: Experimental

Description: Immediate after initiation of invasive mechanical ventilation and randomization, the PEEP level is set to be at 8 cmH2O with an inspired oxygen fraction (FiO2) between 0.21 and 0.6. Thereafter, the PEEP level is adjusted to 1 cmH2O higher to a minimum PEEP level of 10 with every 30 minutes.

Label: Low PEEP

Type: Active Comparator

Description: Immediate after initiation of invasive mechanical ventilation and randomization, the PEEP level is set to be at 5 cmH2O with an inspired oxygen fraction (FiO2) between 0.21 and 0.6. In this arm, the PEEP level is adjusted to 1 cmH2O lower to a minimum PEEP level of 3 with every 30 minutes while maintaining a partial pressure of arterial blood oxygen above 65 mmHg or SpO2 >92% with pulse oxymetry.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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