Clinical trial NCT06796816: Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery
Official title: Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Resection
Adenocarcinoma of Lung
Keywords: bioimpedence
lung cancer
sarcopenia
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2025-01-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Body composition
timeFrame: Day 1, day 2 or 3 and day 45 after surgery
Secondary outcomes:
Other outcomes:
measure: Correlation between preoperative body composition and postoperative course, including the possible occurrence of complications in the cardiopulmonary area
timeFrame: Day 1, day 2 or 3 andday 45 after surgery
measure: Correlation between the operating method (open vs VATS) with short-term impedance values
timeFrame: Day 1, day 2 or 3 and day 45 after surgery
measure: Correlation between CT/PET data on sarcopenia collected at the preoperative examination and occurrence of pulmonary atelectasis
timeFrame: Pre e post surgery (staging/re-staging TC, usually performed within 2 months from surgery)
Locations:
city: Reggio Emilia
country: Italy
facility: AUSL IRCCS di Reggio Emilia
Study officials:
References:
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citation: 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.
citation: 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.