Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery

NCT ID: NCT06796816

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients undergoing surgery for removal of adenocarcinoma of the lung

Group Type: EXPERIMENTAL

Bioelectrical Impedance Vector Analysis (BIVA)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AUSL IRCCS di Reggio Emilia

Reggio Emilia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Cristian Rapicetta, MD

Role: CONTACT

Cristian.rapicetta@ausl.re.it

0522296858

Facility Contacts

Candida Bonelli

Role: primary

candida.bonelli@ausl.re.it

0522296858

Cristian Rapicetta

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 25948283 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27987064 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28792014 (View on PubMed)

Other Identifiers

945/2018/SPER/IRCCSRE

Identifier Type: -

Identifier Source: org_study_id