Lung ResectionBIVA-18NCT06796816
Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery
A study testing Bioelectrical Impedance Vector Analysis (BIVA) in people with Lung Resection and Adenocarcinoma of Lung, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Resection, Adenocarcinoma of Lung
- What is being tested?
- Bioelectrical Impedance Vector Analysis (BIVA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing pulmonary resection surgery for primary neoplasm within a one-year timeframe.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Bioelectrical Impedance Vector Analysis (BIVA)
- Keywords
- bioimpedence, lung cancer, sarcopenia
- Medical subject headings
- Adenocarcinoma of Lung, Lung Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing surgery for removal of adenocarcinoma of the lung | Experimental | Not described Receives: Other: Bioelectrical Impedance Vector Analysis (BIVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Bioimpedence (total body and segmental)
Measured: Day 1, day 2 or 3 and day 45 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Apr 2019
- Primary completion12 Jan 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796816
- Sponsor's protocol ID
- 945/2018/SPER/IRCCSRE
- Acronym
- BIVA-18
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25948283Santarelli 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.
PubMed 27987064Cardoso 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.
PubMed 28792014
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT06796816
- Acronym / sponsor ID
- BIVA-18 / 945/2018/SPER/IRCCSRE
- Conditions
- Lung Resection, Adenocarcinoma of Lung
- Keywords
- bioimpedence, lung cancer, sarcopenia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgery for removal of adenocarcinoma of the lung | Experimental | Other: Bioelectrical Impedance Vector Analysis (BIVA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing pulmonary resection surgery for primary neoplasm within a one-year timeframe.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients undergoing surgery for removal of adenocarcinoma of the lung |
Primary outcome
Body composition
Time frame: Day 1, day 2 or 3 and day 45 after surgery
Bioimpedence (total body and segmental)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 25948283Belfiore 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.
- Background: PubMed 27987064Santarelli 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.
- Background: PubMed 28792014Cardoso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectrical Impedance Vector Analysis (BIVA) in people with Lung Resection and Adenocarcinoma of Lung, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Day 1, day 2 or 3 and day 45 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06796816, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.