NCT06039397

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

September 8, 2023

Last Update Submit

January 11, 2024

Conditions

Cardiac Output, HighHeart FailurePulmonary Edema With Heart FailureDyspnea; CardiacArrythmia

Keywords

Cardiac OutputHeart FailureBody PositioningRight Lateral Body PositionSemifowler

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output

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

    15 Minutes

Study Arms (2)

Semi-fowler 30" Right Lateral

EXPERIMENTAL
Behavioral: Semifowler 30' Right Lateral Body Position

Conventional care

ACTIVE COMPARATOR
Behavioral: Semifowler 30' Right Lateral Body Position

Interventions

Semifowler 30' Right Lateral Body PositionBEHAVIORAL

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

Conventional careSemi-fowler 30" Right Lateral

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryan Budiyanto

Jakarta, West Jakarta, 11420, Indonesia

Location

Related Publications (5)

  • 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.

    PMID: 34335312BACKGROUND

  • 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.

    PMID: 31146871BACKGROUND

  • 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.

    PMID: 9244024BACKGROUND

  • 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.

    PMID: 11401112RESULT

  • 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.

    PMID: 30165874RESULT

Related Links

MeSH Terms

Conditions

Cardiac Output, HighHeart FailureDyspneaArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 15, 2023

Study Start

September 1, 2023

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

ID(1)