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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06039397
Other study ID # 01.202303.046
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 30, 2023

Study information

Verified date January 2024
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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, - willing to be a respondent, - LVEF <50%. Exclusion Criteria: - Pulmonary edema, - severe valve disease comorbidities, - receiving high doses of anti-hypotensive treatment, - heart failure readmission in the last 3 months, - finger edema, - use of mechanical circulatory support, - irregular rhythms, - artificial pacemaker attached, - obesity - peripheral perfusion disorders - cardiogenic shock

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Indonesia Ryan Budiyanto Jakarta West Jakarta

Sponsors (2)

Lead Sponsor Collaborator
Indonesia University National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac Output The amount of blood volume pumped by the heart for 1 minute in liters 15 Minutes
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