Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery (BIVA-18)

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.

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma of Lung; Lung Resection
• Intervention / Treatment: Other: Bioelectrical Impedance Vector Analysis (BIVA)

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristian Rapicetta, MD; Phone Number: 0522296858; Email: Cristian.rapicetta@ausl.re.it

Study Locations

• Italy
  • Reggio Emilia, Italy
    • Recruiting
    • AUSL IRCCS di Reggio Emilia
    • Contact: Candida Bonelli; Phone Number: 0522296858; Email: candida.bonelli@ausl.re.it
    • Contact: Cristian Rapicetta

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients undergoing surgery for removal of adenocarcinoma of the lung

Other: Bioelectrical Impedance Vector Analysis (BIVA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Bioimpedence (total body and segmental)	Day 1, day 2 or 3 and day 45 after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between preoperative body composition and postoperative course, including the possible occurrence of complications in the cardiopulmonary area	Body composition	Day 1, day 2 or 3 andday 45 after surgery
Correlation between the operating method (open vs VATS) with short-term impedance values	Body composition	Day 1, day 2 or 3 and day 45 after surgery
Correlation between CT/PET data on sarcopenia collected at the preoperative examination and occurrence of pulmonary atelectasis	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).	Pre e post surgery (staging/re-staging TC, usually performed within 2 months from surgery)

Collaborators and Investigators

• Sponsor: Azienda Unita Sanitaria Locale Reggio Emilia

Publications and helpful links

General Publications

• Belfiore A, Cataldi M, Minichini L, Aiello ML, Trio R, Rossetti G, Guida B. Short-Term Changes in Body Composition and Response to Micronutrient Supplementation After Laparoscopic Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2344-51. doi: 10.1007/s11695-015-1700-0.
• Santarelli S, Russo V, Lalle I, De Berardinis B, Navarin S, Magrini L, Piccoli A, Codognotto M, Castello LM, Avanzi GC, Villacorta H, Precht BLC, de Araujo Porto PB, Villacorta AS, Di Somma S; Great Network. Usefulness of combining admission brain natriuretic peptide (BNP) plus hospital discharge bioelectrical impedance vector analysis (BIVA) in predicting 90 days cardiovascular mortality in patients with acute heart failure. Intern Emerg Med. 2017 Jun;12(4):445-451. doi: 10.1007/s11739-016-1581-9. Epub 2016 Dec 16. Erratum In: Intern Emerg Med. 2017 Jun;12(4):559. doi: 10.1007/s11739-017-1630-z.
• Cardoso ICR, Aredes MA, Chaves GV. Applicability of the direct parameters of bioelectrical impedance in assessing nutritional status and surgical complications of women with gynecological cancer. Eur J Clin Nutr. 2017 Nov;71(11):1278-1284. doi: 10.1038/ejcn.2017.115. Epub 2017 Aug 9.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer; sarcopenia; bioimpedence
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: 945/2018/SPER/IRCCSRE

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
• product manufactured in and exported from the U.S.: No