Detection of Lung Pathologies Among Dialysis Patients Using Pulsenmore MC™ Device - Feasibility Study

NCT07028060 | Completed DMC

• 1 other identifier: 0539-20-SOR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

PRIMARY OBJECTIVE: To measure success rate and identification of pathological lung B-lines, using novel mobile Self-scan ultrasound device (MC, by Pulsenmore), in chronic renal failure patients, pre and post dialysis. SECONDARY OBJECTIVE: 1.To describe the difference in B-lines score (BLS), pre and post dialysis as measured by the new device. 2\. Examine the degree of agreement in the BLS performed by the new mobile , MC device to the traditional POCUS device. 3\. To describe the identification rate of lung atelectasis and pleural effusion by the study device compared to standard ultrasound machine STUDY DESIGN: A prospective, pilot, single-center study. INTERVENTION: Lung point of care ultrasound (POCUS) performed with a new ultrasound device, MC based on mobile phone among chronic renal failure patients pre and post dialysis. SAMPLE SIZE CONSIDERATIONS: As this is a feasibility study sample size was not calculated, we will perform convenience sample of 30 patients. STUDY PROCEDURES: Lung point of care ultrasound (POCUS) performed with a new MC device on chronic renal failure patients pre and post dialysis. The following data will be collected:

• Demographic factors: age, gender, ethnicity
• Medical history: medications, diabetes mellitus, hypertension, systemic diseases, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), height and weight
• Clinical data: oDates of admission oTreatment: dialysis duration (years) oEssential: heart rate, blood pressure, saturation, weight. Dry weight, BMI. All before and after session
• US results- BLS detected from pictures collected by: o the new MC device o the traditional POCUS device
• Detection of lung atelectasis by o the new MC device o the traditional POCUS device
• Detection of pleural effusion by o the new MC device o the traditional POCUS device OUTCOMES AND ANALYSES:
• Agreement rate between the study MC device and the gold standard ultrasound machine for primary and secondary objectives.
• Time of study in each machine.

Conditions

Hemodialysis Patients

Outcome Measures

Primary Outcomes (1)

• To measure success rate and identification of pathological lung B-lines, using novel mobile phone, Pulsenmore MC device, in chronic renal failure patients, pre and post dialysis.

  To measure success rate and identification of pathological lung B-lines, using novel mobile phone, Pulsenmore MC device, in chronic renal failure patients, pre and post dialysis.

  10 months

Secondary Outcomes (3)

• To describe the difference in B-lines score (BLS), pre and post dialysis as measured by the new device, Pulsenmore MC

  10 months

• Examine the degree of agreement in the BLS performed by the new mobile Pulsenmore MC device to the traditional ultrasound device.

  10 months

• To describe the identification rate of lung atelectasis and pleural effusion by the study

  10 months

Study Arms (1)

Chronic renal failure patients

EXPERIMENTAL

All patients diagnosed with End-stage renal disease (ESRD) and treated with chronic dialysis center at Soroka University Medical Center (SUMC)

Device: PulseNmore MC™

Interventions

PulseNmore MC™ DEVICE

novel mobile Self-scan ultrasound device, Pulsenmore MC™

Chronic renal failure patients

Eligibility Criteria

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

You may qualify if:

• Age over 18
• Patients diagnosed with End-stage renal disease (ESRD) and treated with chronic dialysis center at Soroka University Medical Center (SUMC)
• Cognitive intact and can sign informed consent as decided by their treating nephrologist.
• have smart phone and any social app- like WhatsApp- his or her main care giver

You may not qualify if:

• Morbid obese - BMI\>35
• History of lung resection or lung transplant.

Sponsors & Collaborators

• PulseNmore: lead

Study Sites (1)

Emergency care unit

Beersheba, Israel

Location

Related Publications (13)

• Mallamaci F, Benedetto FA, Tripepi R, Rastelli S, Castellino P, Tripepi G, Picano E, Zoccali C. Detection of pulmonary congestion by chest ultrasound in dialysis patients. JACC Cardiovasc Imaging. 2010 Jun;3(6):586-94. doi: 10.1016/j.jcmg.2010.02.005.

  PMID: 20541714 BACKGROUND

• Saad MM, Kamal J, Moussaly E, Karam B, Mansour W, Gobran E, Abbasi SH, Mahgoub A, Singh P, Hardy R, Das D, Brown C, Kapoor M, Demissie S, Kleiner MJ, El Charabaty E, El Sayegh SE. Relevance of B-Lines on Lung Ultrasound in Volume Overload and Pulmonary Congestion: Clinical Correlations and Outcomes in Patients on Hemodialysis. Cardiorenal Med. 2018;8(2):83-91. doi: 10.1159/000476000. Epub 2017 Nov 29.

  PMID: 29617006 BACKGROUND

• Cogliati C, Casazza G, Ceriani E, Torzillo D, Furlotti S, Bossi I, Vago T, Costantino G, Montano N. Lung ultrasound and short-term prognosis in heart failure patients. Int J Cardiol. 2016 Sep 1;218:104-108. doi: 10.1016/j.ijcard.2016.05.010. Epub 2016 May 13.

  PMID: 27232920 BACKGROUND

• Covic A, Siriopol D, Voroneanu L. Use of Lung Ultrasound for the Assessment of Volume Status in CKD. Am J Kidney Dis. 2018 Mar;71(3):412-422. doi: 10.1053/j.ajkd.2017.10.009. Epub 2017 Dec 21.

  PMID: 29274919 BACKGROUND

• Gargani L, Sicari R, Raciti M, Serasini L, Passera M, Torino C, Letachowicz K, Ekart R, Fliser D, Covic A, Balafa O, Stavroulopoulos A, Massy ZA, Fiaccadori E, Caiazza A, Bachelet T, Slotki I, Shavit L, Martinez-Castelao A, Coudert-Krier MJ, Rossignol P, Kraemer TD, Hannedouche T, Panichi V, Wiecek A, Pontoriero G, Sarafidis P, Klinger M, Hojs R, Seiler-Mussler S, Lizzi F, Onofriescu M, Zarzoulas F, Tripepi R, Mallamaci F, Tripepi G, Picano E, London GM, Zoccali C. Efficacy of a remote web-based lung ultrasound training for nephrologists and cardiologists: a LUST trial sub-project. Nephrol Dial Transplant. 2016 Dec;31(12):1982-1988. doi: 10.1093/ndt/gfw329. Epub 2016 Sep 26.

  PMID: 27672089 BACKGROUND

• Torino C, Gargani L, Sicari R, Letachowicz K, Ekart R, Fliser D, Covic A, Siamopoulos K, Stavroulopoulos A, Massy ZA, Fiaccadori E, Caiazza A, Bachelet T, Slotki I, Martinez-Castelao A, Coudert-Krier MJ, Rossignol P, Gueler F, Hannedouche T, Panichi V, Wiecek A, Pontoriero G, Sarafidis P, Klinger M, Hojs R, Seiler-Mussler S, Lizzi F, Siriopol D, Balafa O, Shavit L, Tripepi R, Mallamaci F, Tripepi G, Picano E, London GM, Zoccali C. The Agreement between Auscultation and Lung Ultrasound in Hemodialysis Patients: The LUST Study. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):2005-2011. doi: 10.2215/CJN.03890416. Epub 2016 Sep 22.

  PMID: 27660305 BACKGROUND

• Liang XK, Li LJ, Wang XH, Wang XX, Wang YD, Xu ZF. Role of Lung Ultrasound in Adjusting Ultrafiltration Volume in Hemodialysis Patients. Ultrasound Med Biol. 2019 Mar;45(3):732-740. doi: 10.1016/j.ultrasmedbio.2018.10.025. Epub 2018 Dec 14.

  PMID: 30558830 BACKGROUND

• Sherman RA. Crackles and Comets: Lung Ultrasound to Detect Pulmonary Congestion in Patients on Dialysis is Coming of Age. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):1924-1926. doi: 10.2215/CJN.09140816. Epub 2016 Sep 22. No abstract available.

  PMID: 27660304 BACKGROUND

• Miglioranza MH, Gargani L, Sant'Anna RT, Rover MM, Martins VM, Mantovani A, Weber C, Moraes MA, Feldman CJ, Kalil RA, Sicari R, Picano E, Leiria TL. Lung ultrasound for the evaluation of pulmonary congestion in outpatients: a comparison with clinical assessment, natriuretic peptides, and echocardiography. JACC Cardiovasc Imaging. 2013 Nov;6(11):1141-51. doi: 10.1016/j.jcmg.2013.08.004. Epub 2013 Oct 2.

  PMID: 24094830 BACKGROUND

• Ross DW, Abbasi MM, Jhaveri KD, Sachdeva M, Miller I, Barnett R, Narasimhan M, Mayo P, Merzkani M, Mathew AT. Lung ultrasonography in end-stage renal disease: moving from evidence to practice-a narrative review. Clin Kidney J. 2018 Apr;11(2):172-178. doi: 10.1093/ckj/sfx107. Epub 2017 Sep 28.

  PMID: 29644056 BACKGROUND

• Martindale JL. Resolution of sonographic B-lines as a measure of pulmonary decongestion in acute heart failure. Am J Emerg Med. 2016 Jun;34(6):1129-32. doi: 10.1016/j.ajem.2016.03.043. Epub 2016 Mar 19.

  PMID: 27061502 BACKGROUND

• Miglioranza MH, Picano E, Badano LP, Sant'Anna R, Rover M, Zaffaroni F, Sicari R, Kalil RK, Leiria TL, Gargani L. Pulmonary congestion evaluated by lung ultrasound predicts decompensation in heart failure outpatients. Int J Cardiol. 2017 Aug 1;240:271-278. doi: 10.1016/j.ijcard.2017.02.150.

  PMID: 28606680 BACKGROUND

• Annamalai I, Balasubramaniam S, Fernando ME, Srinivasaprasad ND, Suren S, Thirumalvalavan K, Veerakumar AM. Volume Assessment in Hemodialysis: A Comparison of Present Methods in Clinical Practice with Sonographic Lung Comets. Indian J Nephrol. 2019 Mar-Apr;29(2):102-110. doi: 10.4103/ijn.IJN_78_18.

  PMID: 30983750 BACKGROUND

Study Design

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

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: June 19, 2025
• Study Start: December 15, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

IL (1)