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NCT Number: NCT06796816

Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Patients with chronic atrial fibrillation (AF).
  • Patients who have previously undergone major pulmonary resection.
  • Patients with pacemakers or implantable devices, as the use of bioimpedance vector analysis (BIVA) may be contraindicated.

Treatment and study plan

Bioelectrical Impedance Vector Analysis (BIVA)

Other

Bioelectrical Impedance Vector Analysis (BIVA) both in total body mode (Total Body Water) and segmental mode. The device used is the "BIA 101 Anniversary" by Akern. The BIVA exam will be performed in total body and segmental modes.

For total body mode, the patient should be placed on a non-conductive surface. After cleansing the skin with alcohol or mild soap, 4 electrodes will be placed: 2 on the right hand (metacarpal area) and 2 on the right foot (metatarsal). The cable connected to your instrument will then be connected to the electrodes. After the instrument is switched on, the variables are read and then analysed. For segmental mode, the patient should be placed on a non-conductive surface. After cleansing the skin with alcohol or mild soap, 8 electrodes will be placed: 2 on the right hand (metacarpal area) and 2 on the left hand, 2 on the right foot (metatarsal) and 2 on the left foot.

Primary outcomes

  1. Body composition

    Time frame: Day 1, day 2 or 3 and day 45 after surgery

    Bioimpedence (total body and segmental)

Other outcomes

  1. Correlation between preoperative body composition and postoperative course, including the possible occurrence of complications in the cardiopulmonary area

    Time frame: Day 1, day 2 or 3 andday 45 after surgery

    Body composition

  2. Correlation between the operating method (open vs VATS) with short-term impedance values

    Time frame: Day 1, day 2 or 3 and day 45 after surgery

    Body composition

  3. Correlation between CT/PET data on sarcopenia collected at the preoperative examination and occurrence of pulmonary atelectasis

    Time frame: Pre e post surgery (staging/re-staging TC, usually performed within 2 months from surgery)

    CT/PET data on sarcopenia will be collected from scans without contrast agents during CT or PET-CT staging, selecting the scan closest to surgery. Parameters measured include cross-sectional area of the pectoral muscle, abdominal muscles (abdominal, psoas, paravertebral) at L3, and thigh root muscles; skeletal muscle index (area/height²) at the pectoral muscle, abdominal muscles at L3, and thigh root; skeletal muscle density (mean HU) at the pectoral muscle, abdominal muscles at L3, and thigh root; intramuscular adipose tissue (IMAT) in these regions; and visceral (VAT) and subcutaneous (SAT) adipose tissue at L3. Data will be analyzed using OsiriX software, selecting slices for each level, setting density windows (-29 to 150 HU for muscle, -30 to -190 HU for adipose tissue), and manually plotting regions of interest (ROI).

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Acronym: BIVA-18

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2025
Registry last updated
Jul 17, 2026

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

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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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