Comparison of PEEP in Acute Decompensated Heart Failure

NCT ID: NCT04853563

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2024-04-30

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.

Conditions

Heart Decompensation; Mechanical Ventilation Pressure High

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High PEEP

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

Group Type: EXPERIMENTAL

PEEP

Intervention Type: OTHER

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

Low PEEP

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

Group Type: ACTIVE_COMPARATOR

PEEP

Intervention Type: OTHER

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

Interventions

PEEP

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

Intervention Type: OTHER

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 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Min-Seok Kim

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Minseok Kim

Role: CONTACT

msk@amc.seoul.kr

(82-2)-3010-3948

Facility Contacts

Min Seok Kim, PhD

Role: primary

guess124@gmail.com

02-3010-3948

References

Hyun J, Kim IC, Kim AR, Lee HJ, Lee SE, Yun SC, Kim MS. Comparison of High Versus Low Positive End-Expiratory Pressure in Mechanically Ventilated Patients With Acute Heart Failure: Rationale and Design of the HELP-AHF Trial. Int J Heart Fail. 2025 Apr 23;7(2):79-84. doi: 10.36628/ijhf.2025.0014. eCollection 2025 Apr.

Reference Type: DERIVED

PMID: 40519712 (View on PubMed)

Other Identifiers

AMC_2021_0433

Identifier Type: -

Identifier Source: org_study_id