Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery

NCT06796816 | Recruiting

• 1 other identifier: 945/2018/SPER/IRCCSRE
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Resection; Adenocarcinoma of Lung

Keywords

bioimpedence; lung cancer; sarcopenia

Outcome Measures

Primary Outcomes (1)

• Body composition

  Bioimpedence (total body and segmental)

  Day 1, day 2 or 3 and day 45 after surgery

Other Outcomes (3)

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

  Day 1, day 2 or 3 andday 45 after surgery

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

  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

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

Study Arms (1)

Patients undergoing surgery for removal of adenocarcinoma of the lung

EXPERIMENTAL

Other: Bioelectrical Impedance Vector Analysis (BIVA)

Interventions

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.

Patients undergoing surgery for removal of adenocarcinoma of the lung

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

AUSL IRCCS di Reggio Emilia

Reggio Emilia, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 25948283 BACKGROUND

• 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.

  PMID: 27987064 BACKGROUND

• 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.

  PMID: 28792014 BACKGROUND

MeSH Terms

Conditions

Adenocarcinoma of Lung; Lung Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Cristian Rapicetta, MD

CONTACT

0522296858; Cristian.rapicetta@ausl.re.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: April 2, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)