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CompletedNCT06295445Updated Mar 12, 2024

Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit

An interventional study of care cardio-pulmonary ultrasound and treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management in Shock, sponsored by Egymedicalpedia. Completed at 1 site in Egypt. Open to participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Egymedicalpedia · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Mar 2022, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study summary

Shock is one of the most common conditions in the intensive care unit (ICU) affecting one-third of critically ill patients. It reduces oxygen and nutrition's perfusion to the solid organs and is closely associated with increased mortality. Most literature has described how hemodynamic monitoring could provide an effective way to identify underlying pathophysiological processes and guide appropriate therapy in shock patients.

Read the detailed description

The diagnosis of shock is based on clinical, hemodynamic, and biochemical signs. It is manifested with systemic arterial hypotension with mean arterial pressure less than 70 mm Hg, with reflex tachycardia. Also, there are clinical signs of tissue hypoperfusion, including cutaneous hypoperfusion with cold clammy skin, renal hypoperfusion with resulting oliguria (urine output [UOP] \<0.5 ml/kg/h) and neurologic hypoperfusion with altered mental state. Tissue hypoperfusion leads to anaerobic tissue metabolism with hyperlactatemia (>1.5 mmol/L).

Assessment of hemodynamic status and lines of management of the acute circulatory shock remains a challenging issue in emergency medicine and critical care. As the use of invasive hemodynamic monitoring declines, bedside-focused ultrasound (US) has become a valuable tool in the evaluation and management of patients in shock.

Four types of shock exist, including hypovolemic, cardiogenic, distributive, and obstructive shock. Clinical assessment and classification of shock is extremely difficult in critically ill patients as there is sometimes an overlap between these types. Incorporation of bedside ultrasound in patients with undifferentiated shock allows for rapid evaluation of reversible causes of shock and improves accurate diagnosis in undifferentiated hypotension.

Currently, the critical care ultrasound (CCUS) has been widely advocated as the preferred tool to assess hemodynamics, including accurately estimating pathophysiological changes of shock. This information, therefore, can be carried out into protocols to guide shock treatment. However, despite previous recommendations, current protocols are subjective and empirical, without listing specific variables as indicators, such as ejection fraction (EF), mitral annular plane systolic excursion (MAPSE), tricuspid annular plane systolic excursion (TAPSE),mitral or tricuspid annular peak systolic velocity (S'-MV or S'-TV), inferior vena cava (IVC), and lung ultrasound score (LUSS).

CCUS examination on ICU admission which performed by the experienced physician provide valuable information to assist the caregivers in understanding the comprehensive outlook of the characteristics of hemodynamics and lung pathology. Those key variables obtained by CCUS predict the possible prognosis of patients, hence deserve more attention in clinical decision making.

Lung ultrasound has been widely used in diagnosing pulmonary diseases including pneumonia, connective tissue diseases and interstitial lung diseases. For patients in the intensive care unit (ICU), more attention is paid to monitoring the development of lung pathologic changes, which guides the therapy. Lung insults caused by inflammation, trauma or water increase always lead to infiltration, which results in the loss of lung air. Depending on the severity of the aeration loss and water increase, each part of the lung generates different ultrasound signs upon exam.

The lung ultrasound score (LUSS) is the sum of the scores of each exam zone and has been justified as a respectable semiquantitative score to measure the lung aeration loss caused by different lung pathologic changes, such as pneumonia, atelectasis, pleural effusion, and lung edema.

Lung Ultrasound Protocol (LUSS): Reliable techniques have been used based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound examination to evaluate the LUSS. The anterior and lateral chest wall are divided into eight areas. Areas 1 and 2 denote the upper anterior and lower anterior chest areas, respectively, and areas 3 and 4 denote the upper lateral and basal lateral chest areas, respectively.

02

Conditions studied

  • Shock

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03

In context

Shock

916 studies on the registry are indexed under Shock; 176 are open to participants now.

This study's enrollment of 108 is above the median of 77 across 540 interventional studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • state of hypotension represented by systolic BP \<90 mm Hg or mean arterial pressure (MAP) \<60 mmHg).
  • serum lactate level of ≥ 2 mmol/L
  • positive with at least one of the conditions below: Lactate level >2mmol/L.
  • Capillary Refill Time >4.5s; Urine output per hour \<0.5ml/kg; Clammy skin, limbs cold. unconsciousness. initiation of intravenous vasopressors .

Exclusion criteria

Exclusion Criteria:

  • Patients with trauma history,
  • Patients with suspected or diagnosed raised intra-abdominal or intrathoracic pressures as pregnancy, Portal hypertension, Mediastinal mass, Intracerebral hemorrhage, Increased intracranial pressure, Valvular heart disease,Atrial fibrillation.
  • Patients or families refused to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    Group A: Control group

    About 54 patients that will undergo treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management.

    Other: treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management

  • Experimental
    Group B: Study group

    About 54 patients that will undergo cardio-pulmonary ultrasound guided management.

    Procedure: care cardio-pulmonary ultrasound

Interventions

  • Procedurecare cardio-pulmonary ultrasound

    Evaluation of the heart and lung conditions in shocked patients using focused cardio-pulmonary ultrasound for treatment guidance and their implication on the patient's outcome

    Also known as: Echo

  • Othertreatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management

    treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management

06

What researchers measure

Primary outcomes

  1. Mortality rate

    Time of mortality occurrence since randomization, comparing intervention and control group.

    Time frame: 72 hours of the initial fluid resuscitation

  2. Number of mortalities

    Amount of non-survivor subject, comparing intervention and control group.

    Time frame: 72 hours of the initial fluid resuscitation

07

Study locations

1 site
  • Al-Azhar University hospitals
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06295445
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
Mar 6, 2024
Start date
Mar 1, 2022
Primary completion
Sep 1, 2023
Completion
Sep 15, 2023
Last update
Mar 12, 2024

Study contacts

Ayman Hussein Fahmy, Professor
study chair · Anesthesia, Intensive Care and Pain Management Department,Al-Azhar University, Faculty of medicine for boys
Moaz Atef El-Shahat, Lecturer
study director · Chest Diseases Department,Al-Azhar Faculty of Medicine
Hani Abdelshafook, Lecturer
principal investigator · Cardiology Department, Al-Azhar Faculty of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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