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RecruitingNCT05947942Updated Jul 17, 2023

Thoracic Fluid Content for Weaning Parameters

An observational study in Lung; Congestive, sponsored by Benha University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Benha University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The study aims to compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion.

Read the detailed description

lung congestion was defined as distention of blood vessels in the lungs and filling of the alveoli with fluid as a result of an infection, high blood pressure, or cardiac insufficiencies (i.e., inability of the heart to function adequately.

The process of weaning from ventilatory support takes almost 40% of the time spent on ventilator. Weaning indices like spontaneous tidal volumes, minute ventilation and rapid shallow breathing index, have been used extensively in clinical practice for weaning purposes . These parameters measure the overall respiratory volumes produced by the muscles of breathing and do not take into account the independent contribution of the diaphragm. During resting, the main muscle of breathing is the diaphragm .

Diaphragmatic excursion is the movement of the thoracic diaphragm during breathing. Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. Diaphragmatic excursion is positively correlated with lung inspiratory volumes and can accurately reflect the muscle strength and function . Diaphragmatic excursion is an index for respiratory muscle fatigue during the spontaneous breathing trial (SBT).

Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device. The ICON device is one relatively new proprietary implementation of impedance cardiography technology, which is also often called thoracic electrical bioimpedance .

Impedance cardiography is based on measuring the changes in total resistance of the thorax to electric current. The impedance to electric current is determined by the resistance of different tissues such as bone, muscles, and fluids. The fluid compartment is considered the dynamic component that would cause short term changes in thoracic impedance . TFC is calculated as the reciprocal of the total thoracic impedance and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid . Although TFC is a measure of both extra and intravascular thoracic fluid, it might provide an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary congestion , we hypothesized that TFC, as an estimate of lung congestion, can serve as predictor for weaning outcomes in critically ill patient.

02

Conditions studied

  • Lung; Congestive
03

In context

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

The study will be conducted on 100 patients admitted to critical care department at Benha university hospitals with lung congestion. Patients who are candidate for weaning from invasive mechanical ventilation (after 48 h) and who agree to participate in the study will be involved.

Inclusion criteria

    • Patients of both genders aged 18-70 years old.

      • Acute Physiology and Chronic Health Evaluation II (APACHE II) score
      • Patients with congested lung including; Acute exacerbation of COPD patients with acute respiratory failure (PaO2/FiO2 ratio ≤300 or PaCO2 ≥ 50 mm Hg at intubation), pneumonia, chronic kidney disease, heart failure (New York Heart Association Classification III, IV) who will be candidate for weaning from invasive mechanical ventilation according to the treating physician's judgement using the ICU weaning protocol.

Exclusion criteria

Exclusion Criteria:

    • Patients younger than 18 years or older than 70 years

      • Refusal to participate.
      • Obesity (BMI≥35).
      • Pregnancy.
      • Patients with pneumothorax, pleural, or pericardial effusion, lung contusion, and thoracotomy.
      • Hepatic dysfunction.
      • history or new detection of paralysis (no movement) or paradoxical movement of a single hemidiaphragm.
      • preexisting cervical spinal injury, history of neuromuscular disorders
      • Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes will be also excluded from the study.
      • Mechanical ventilation \< 48 hrs
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Thoracic fluid content by electrical cardiometry versus diaphragmatic excursion by Ultrasound for prediction of weaning success in patients with lung congestion

    compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Shawky meselhi shawky
    Cairo, Egypt
    • Enas Wageh, MD · Contact
    Recruiting
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 Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05947942
Lead sponsor
Benha University
Responsible party
Shawky Elshaer (Doctor, Benha University) — Principal investigator
First posted
Jul 17, 2023
Start date
May 20, 2023
Primary completion
Mar 20, 2024 (estimated)
Completion
Apr 20, 2024 (estimated)
Last update
Jul 17, 2023

Study contacts

Shawky Elshaer
Contact
elshaershawky@gmail.com
01024542387

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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