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Enrolling by Invitation

NCT Number: NCT07305870

Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units

Objectives of The Study:

1. Assess the effectiveness of sequential compression device on distributive peripheral edema and hemodynamic stability for patients in critical care units. 2. Find out relationships between the effectiveness of sequential compression device, range of motion, and synergic effectiveness of both interventions with patients' demographic characteristics.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerbala health department

Karbala, Center, 56001, Iraq

About this study

Globally, approximately (13-20) million people treated in intensive care units (ICUs) each year, where common complications such as edema are due to prolonged immobility and critical illness . Edema refers to accumulation of excess fluid in body tissues, manifesting in multi forms such as cerebral, pulmonary, or ocular edema. Peripheral edema considered one of the most prevalent types, specifically represents to swelling in the limbs. It caused by imbalance between oncotic and hydrostatic pressures, leading to increased capillary permeability and fluid accumulation in the interstitial space(Smith et al., 2024).

A study found that hospital mortality was significantly higher in those presenting with peripheral edema (22.2%) compared with those without (12.6%) among 12,778 critically ill patients. Also, the severity of edema at admission correlated with increased mortality risk.

The prevalence of peripheral lower limb edema among older adults in U.S was 20.0%, 19.4%, 19.0%, 19.0%, and 19.1% in 2000, 2004, 2008, 2012, and 2016, respectively. It was significantly associated with clinical, demographic, and lifestyle factors, including obesity, diabetes, hypertension, pain, low physical activity, mobility limitations, advanced age, female sex, minority race, and low socioeconomic status.

In Japan, the Ministry of Health, Labor, and Welfare reported an increase in the number of patients with severe motion disabilities, particularly among individuals over 60 years old. Similarly, data from the Health and Retirement Study revealed that chronic peripheral edema affects approximately 19% to 20% of older adults, particularly among women, racial minorities, and individuals with limited mobility.

Peripheral edema is a multifactorial and complex condition that affects patients suffering from a various of diseases. Its underlying pathology varies considerably, with common causes including congestive heart failure (CHF), liver disease, vascular conditions such as chronic venous insufficiency, and postoperative surgical complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients who were hospitalized in critical care units.
  • Subjects over the age of 18 years.
  • Presence of peripheral edema (pitting edema ≥1+ in lower extremities).
  • Patients how are hemodynamically stable.
  • Patients how are able to tolerate positioning for interventions.

Exclusion criteria

  • Patients with lymphedema.
  • Patients with chronic kidney disease.
  • patients with presence of deep vein thrombosis, severe peripheral arterial disease, or phlebitis.
  • patients with open wounds, ulcers, or skin infections on lower limbs.
  • patients with fractures, orthopedic surgery, or joint immobility in lower extremities.
  • patients with severe cardiac failure or pulmonary edema.

Treatment and study plan

Sequential Compression Device

Device

Sequential Compression Device (SCD) protocol involves a pump linked to calf and thigh braces with individual tubes, applying moderate pressure of approximately 60mmHg through a graduated air chamber in a sequential cycle across four compartments. The inflation lasts for 12 seconds followed by a 48-second deflation, with sessions lasting 2 hours daily for 5 consecutive days.

Primary outcomes

  1. Peripheral edema

    Time frame: The degree of edema will be measured before applying interventions and after 5 consecutive days if study

    Firstly, the edema of lower extremities was measured for all patients in critical care units through pitting edema scale before selecting the participants, then the patients selected for the current study had pitting edema scale >+1. Also, leg circumference had measured by using tape measurement.

  2. Hemodynamic Stability

    Time frame: Hemodynamic parameters will be measured before applying interventions and after 5 consecutive days if study

    Hemodynamic parameters were also assessed before interventions. The Hemodynamic parameters that include the heart rate, blood pressure, respiratory rate, urine output and saturation of oxygen was measured by observation of the reading on the monitoring device that was used in critical care units and attached to the patient, the reading was documented by the researcher.

Sponsors and collaborators

Lead sponsor

Karbala University

Other

Registry information

Official study title

Effectiveness of Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units

Acronym: SCD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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