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

Effectiveness of 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Peripheral Edema
• Intervention / Treatment: Device: Sequential compression device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Center
    • Karbala, Center, Iraq, 56001
      • Kerbala health department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sequential Compression Device group; Sequential Compression Device (SCD) participants group 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.	Device: Sequential compression 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.
No Intervention: control group; control group will receives standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral edema	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.	The degree of edema will be measured before applying interventions and after 5 consecutive days if study
Hemodynamic Stability	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.	Hemodynamic parameters will be measured before applying interventions and after 5 consecutive days if study

Collaborators and Investigators

• Sponsor: Karbala University
• Investigators: Principal Investigator: Hussein H Jawad MGS study principal investigator, Kerbala health department

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2025
• Primary Completion (Actual): March 15, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Sequential compression device, Peripheral edema, Hemodynamic stability
• Other Study ID Numbers: uok.coN.25.099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No