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

Sponsor

Ryan Budiyanto (Other)

Overall Status

Recruiting

CT.gov ID

NCT06039397

Collaborator

National Cardiovascular Center Harapan Kita Hospital Indonesia (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

13.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Output, High Heart Failure Pulmonary Edema With Heart Failure Dyspnea; Cardiac Arrythmia	Behavioral: Semifowler 30" Right Lateral Body Position	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LVEF <50%	Behavioral: Semifowler 30" Right Lateral Body Position 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
Active Comparator: LVEF>30%	Behavioral: Semifowler 30" Right Lateral Body Position 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

Arm

Intervention/Treatment

Active Comparator: LVEF <50%

Behavioral: Semifowler 30" Right Lateral Body Position

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

Active Comparator: LVEF>30%

Behavioral: Semifowler 30" Right Lateral Body Position

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

Outcome Measures

Primary Outcome Measures

Cardiac Output [15 Minutes]
The amount of blood volume pumped by the heart for 1 minute in liters

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.