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

January 11, 2024 updated by: Ryan Budiyanto, Indonesia University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Jakarta
      • Jakarta, West Jakarta, Indonesia, 11420
        • Ryan Budiyanto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional care
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
Experimental: Semi-fowler 30" Right Lateral
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Output
Time Frame: 15 Minutes
The amount of blood volume pumped by the heart for 1 minute in liters
15 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

National Cardiovascular Center Harapan Kita Hospital Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01.202303.046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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