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The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure (SETTLECO)

Primary Purpose

Cardiac Output, High, Heart Failure, Pulmonary Edema With Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Semifowler 30" Right Lateral Body Position
Sponsored by
Ryan Budiyanto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Output, High focused on measuring Cardiac Output, Heart Failure, Body Positioning, Right Lateral Body Position, Semifowler

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient was diagnosed with acute decompensated heart failure, fully conscious, not intubated, >18 years old, had no mobility problems, palpable radial artery pulsation, was not under the influence of anti-hypotensive drugs, was willing to be a respondent, LVEF <50%. Exclusion Criteria: Pulmonary edema, severe valve disease comorbidities, and receiving high doses of anti-hypotensive treatment, heart failure remission in the last 3 months, finger edema, use of mechanical circulatory aids, irregular rhythms, artificial pacemaker attached, peripheral perfusion disorders.

Sites / Locations

  • Ryan BudiyantoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LVEF <50%

LVEF>30%

Arm Description

Outcomes

Primary Outcome Measures

Cardiac Output
The amount of blood volume pumped by the heart for 1 minute in liters

Secondary Outcome Measures

Full Information

First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Ryan Budiyanto
Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT06039397
Brief Title
The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure
Acronym
SETTLECO
Official Title
The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ryan Budiyanto
Collaborators
National Cardiovascular Center Harapan Kita Hospital Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Heart failure is a special clinical syndrome such as difficulty breathing, fatigue, and swollen legs characterized by increased JVP, crackle lung sounds, and peripheral edema caused by heart disorders both structural and/or functional, resulting in decreased cardiac output and increased intracardiac pressure at rest and activity. Body positioning has been shown to affect stroke volume and parasympathetic modulating activity. The right lateral 30" semifowler position is a very safe position in heart failure patients admitted to the ICU. Although body positioning can affect stroke volume, and parasympathetic modulation, it is not yet clear what effect it has on cardiac output

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, High, Heart Failure, Pulmonary Edema With Heart Failure, Dyspnea; Cardiac, Arrythmia
Keywords
Cardiac Output, Heart Failure, Body Positioning, Right Lateral Body Position, Semifowler

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LVEF <50%
Arm Type
Active Comparator
Arm Title
LVEF>30%
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Semifowler 30" Right Lateral Body Position
Intervention Description
Semifowler 30' Right Lateral Body Position Is a regulation of body position by placing the patient's body in a semi-fowler and lateral resting position of 30 degrees
Primary Outcome Measure Information:
Title
Cardiac Output
Description
The amount of blood volume pumped by the heart for 1 minute in liters
Time Frame
15 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient was diagnosed with acute decompensated heart failure, fully conscious, not intubated, >18 years old, had no mobility problems, palpable radial artery pulsation, was not under the influence of anti-hypotensive drugs, was willing to be a respondent, LVEF <50%. Exclusion Criteria: Pulmonary edema, severe valve disease comorbidities, and receiving high doses of anti-hypotensive treatment, heart failure remission in the last 3 months, finger edema, use of mechanical circulatory aids, irregular rhythms, artificial pacemaker attached, peripheral perfusion disorders.
Facility Information:
Facility Name
Ryan Budiyanto
City
Jakarta
State/Province
West Jakarta
ZIP/Postal Code
11420
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Budiyanto
Phone
+62215684093
Ext
1262
Email
ryanbudiyanto.ui@gmail.com
First Name & Middle Initial & Last Name & Degree
National Cardiovascular Center Harapan Kita
Ext
1262
Email
ryanbudiyanto.ui@gmail.com
First Name & Middle Initial & Last Name & Degree
Ryan Budiyanto

12. IPD Sharing Statement

Citations:
PubMed Identifier
34335312
Citation
Gottlieb LA, Blanco LSY, Hocini M, Dekker LRC, Coronel R. Self-Reported Onset of Paroxysmal Atrial Fibrillation Is Related to Sleeping Body Position. Front Physiol. 2021 Jul 15;12:708650. doi: 10.3389/fphys.2021.708650. eCollection 2021.
Results Reference
background
PubMed Identifier
31146871
Citation
Carlisle MA, Fudim M, DeVore AD, Piccini JP. Heart Failure and Atrial Fibrillation, Like Fire and Fury. JACC Heart Fail. 2019 Jun;7(6):447-456. doi: 10.1016/j.jchf.2019.03.005.
Results Reference
background
PubMed Identifier
9244024
Citation
Chen GY, Kuo CD. The effect of the lateral decubitus position on vagal tone. Anaesthesia. 1997 Jul;52(7):653-7. doi: 10.1111/j.1365-2044.1997.114-az0106.x.
Results Reference
background
PubMed Identifier
11401112
Citation
Miyamoto S, Fujita M, Sekiguchi H, Okano Y, Nagaya N, Ueda K, Tamaki S, Nohara R, Eiho S, Sasayama S. Effects of posture on cardiac autonomic nervous activity in patients with congestive heart failure. J Am Coll Cardiol. 2001 Jun 1;37(7):1788-93. doi: 10.1016/s0735-1097(01)01249-9.
Results Reference
result
PubMed Identifier
30165874
Citation
Pan H, Xu Z, Yan H, Gao Y, Chen Z, Song J, Zhang Y. Lying position classification based on ECG waveform and random forest during sleep in healthy people. Biomed Eng Online. 2018 Aug 30;17(1):116. doi: 10.1186/s12938-018-0548-7.
Results Reference
result
Links:
URL
https://www.lontar.ui.ac.id/detail?id=20390020&lokasi=lokal
Description
Effect of right lateral position on hemodynamics and comfort of patients with heart failure at Harapan Kita

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The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure

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