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NCT06796816Active, not recruiting

Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

The assessment of surgical and postoperative risks in thoracic surgery is a field of significant interest because the surgical procedure causes substantial changes in the body's homeostasis. The postoperative course is characterized by considerable clinical variability compared to the preoperative classification, which highlights more homogeneous data among various patient groups. This variability appears to result from individual differences in response to extensive pulmonary resections. Notably, the homogeneity of preoperative data does not correlate with the greater variability observed in the postoperative course. The application of algorithms derived from BIVA in bioimpedance studies has proven particularly useful for prognostic assessments in oncology, as it can evaluate a patient's hydration status and muscle reserves at the time of diagnosis or the start of clinical/surgical treatment. Understanding body composition, particularly the quantity and/or quality of muscle mass, is essential for diagnosing sarcopenia. By passing a low-intensity alternating current (imperceptible to the patient) through the body, BIVA measures provide insights into body water distribution (both intracellular and extracellular), lean mass and skeletal muscle mass. Overall, the test offers a detailed picture of hydration status and skeletal muscle composition. Another validated tool for assessing sarcopenia, which provides information on both muscle quantity (via cross-sectional area measurements) and muscle quality (via muscle density measurements), is computed tomography (CT). CT imaging is typically performed for diagnostic and staging purposes before surgery in thoracic surgery patients, either alone or in combination with positron emission tomography (PET). Our study will focus on assessing correlations between clinical, imaging, and bioimpedance data and postoperative outcomes, with particular attention to the incidence of atrial fibrillation (AF), pulmonary atelectasis requiring treatment, and increased pleural drainage production. Additionally, we will evaluate the relationship between the surgical approach (open surgery vs. video-assisted thoracoscopic surgery, or VATS) and short-term bioimpedance values.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
22 Jan 2025
Start date
1 Apr 2019
Primary completion date
12 Jan 2026
Lead sponsor
Azienda USL Reggio Emilia - IRCCS
Diseases
Lung cancer
NCT number
NCT06796816

What you commit to

  • Study type: Interventional
  • Planned participants: 1000
  • From 1 Apr 2019 to the primary completion date, 12 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have previously undergone major pulmonary resection.

Other

  • Patients with chronic atrial fibrillation (AF).
  • Patients with pacemakers or implantable devices, as the use of bioimpedance vector analysis (BIVA) may be contraindicated.

Who the study is looking for

  • \- Patients undergoing pulmonary resection surgery for primary neoplasm within a one-year timeframe.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
AUSL IRCCS di Reggio Emilia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.