Back to resultsComparison of PEEP in Acute Decompensated Heart Failure
Primary Purpose
Heart Decompensation, Mechanical Ventilation Pressure High
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEEP
Sponsored by
About this trial
This is an interventional treatment trial for Heart Decompensation
Eligibility Criteria
Inclusion Criteria:
- 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
- Age over 19 years old
- 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:
- Subject who are on mechanical circulatory support (ECMO, intra-aortic balloon pump, VAD) at the time of randomization
- Subject who has cardiac abnormality that requires emergent or urgent percutaneous or surgical valvular procedure
- Subject who are on vasoactive or inotropic agents at least moderate dose defined as vasoactive-inotropic score >10
- Isolated preload-dependent cardiac dysfunction (isolated right ventricular failure, right ventricular infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction)
- 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.
- Subject who are not on mechanical ventilation before open heart surgery
- Subject who received unwitness cardiopulmonary rescucitation (CPR) or witness CPR lasting more than 30 minutes
- Subject who was already diagnosed or is suspected to have hypertophic cardiomyopathy with significant left ventricular outflow tract (LVOT) obstruction
- Subject with intracranial hemorrahge or ischemic stroke at the time of randomization
- Subject with irreversible neurologic damage or irreversible hepatic failure
- Invasive mechanical ventilation lasting more than 24 hours preceding endotracheal intubation
- Subject with underlying chronic obstructive pulmonary disease (GOLD classification III or IV) or restrictive pulmonary disease (e.g. interstitial lung disease)
- Subject with impaired consciousness that can not perform self coughing and need suction to maintain adequate airway patency
- Pregnant and/or lactating women
- Subject with life expectancy less than a year
- Subject who is not suitable to enrollment by investigator's discretion
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High PEEP
Low PEEP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04853563
Brief Title
Comparison of PEEP in Acute Decompensated Heart Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Decompensation, Mechanical Ventilation Pressure High
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High PEEP
Arm Type
Experimental
Arm Description
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.
Arm Title
Low PEEP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PEEP
Intervention Description
High PEEP targeted to 10 cmH2O to be maintained during the period of mechanical ventilation compared with low PEEP maintaining 3-5 cmH2O
Primary Outcome Measure Information:
Title
Ventilator-free day at 28-day
Description
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.
Time Frame
up to 28-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Age over 19 years old
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:
Subject who are on mechanical circulatory support (ECMO, intra-aortic balloon pump, VAD) at the time of randomization
Subject who has cardiac abnormality that requires emergent or urgent percutaneous or surgical valvular procedure
Subject who are on vasoactive or inotropic agents at least moderate dose defined as vasoactive-inotropic score >10
Isolated preload-dependent cardiac dysfunction (isolated right ventricular failure, right ventricular infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction)
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.
Subject who are not on mechanical ventilation before open heart surgery
Subject who received unwitness cardiopulmonary rescucitation (CPR) or witness CPR lasting more than 30 minutes
Subject who was already diagnosed or is suspected to have hypertophic cardiomyopathy with significant left ventricular outflow tract (LVOT) obstruction
Subject with intracranial hemorrahge or ischemic stroke at the time of randomization
Subject with irreversible neurologic damage or irreversible hepatic failure
Invasive mechanical ventilation lasting more than 24 hours preceding endotracheal intubation
Subject with underlying chronic obstructive pulmonary disease (GOLD classification III or IV) or restrictive pulmonary disease (e.g. interstitial lung disease)
Subject with impaired consciousness that can not perform self coughing and need suction to maintain adequate airway patency
Pregnant and/or lactating women
Subject with life expectancy less than a year
Subject who is not suitable to enrollment by investigator's discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minseok Kim
Phone
(82-2)-3010-3948
Email
msk@amc.seoul.kr
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Seok Kim, PhD
Phone
02-3010-3948
Email
guess124@gmail.com
12. IPD Sharing Statement
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Comparison of PEEP in Acute Decompensated Heart Failure
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