Study Summary
This trial is looking at whether using a digital chest tube drainage system instead of an analog one has benefits for pediatric patients.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 2 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Madela THOPAZ Suction Pump
1 of 2
Atrium Dry Suction Control Water Seal Chest Drain
1 of 2
Active Control
140 Total Participants · 2 Treatment Groups
Primary Treatment: Madela THOPAZ Suction Pump · No Placebo Group · Phase < 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age No minimum age - 17 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Munnell, Edward R.. 1997. “Thoracic Drainage”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/s0003-4975(97)00082-9.
- Brocki, Marian, Marcin Wawrzycki, Jacek Smigielski, Marcin Kozakiewicz, and Slawomir Jablonski. 2013. “Efficacy Assessment of the Drainage with Permanent Airflow Measurement in the Treatment of Pneumothorax with Air Leak”. The Thoracic and Cardiovascular Surgeon. Georg Thieme Verlag KG. doi:10.1055/s-0033-1359714.
- Lee, Song Am, Jun Seok Kim, Hyun Keun Chee, Jae Joon Hwang, Michael Ji, Yo Han Kim, Hyeong Ju Moon, and Woo Surng Lee. 2021. “Clinical Application of a Digital Thoracic Drainage System for Objectifying and Quantifying Air Leak Versus the Traditional Vacuum System: A Retrospective Observational Study”. Journal of Thoracic Disease. AME Publishing Company. doi:10.21037/jtd-20-2993.
- Gilbert, Sebastien, Anna L. McGuire, Sonam Maghera, Sudhir R. Sundaresan, Andrew J. Seely, Donna E. Maziak, Farid M. Shamji, and P. James Villeneuve. 2015. “Randomized Trial of Digital Versus Analog Pleural Drainage in Patients with or Without a Pulmonary Air Leak After Lung Resection”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2015.08.051.
- Costa Jr, Altair da Silva, Thiago Bachichi, Caio Holanda, and Luiz Augusto Lucas Martins De Rizzo. 2016. “An Initial Experience with a Digital Drainage System During the Postoperative Period of Pediatric Thoracic Surgery”. Jornal Brasileiro De Pneumologia. FapUNIFESP (SciELO). doi:10.1590/s1806-37562016000000269.
- Pérez-Egido, Laura, María Antonia García-Casillas, Isabel Simal, María Fanjul, Agustin Cañizo, Julio A. Cerdá, Beatriz Fernandez, Manuel de la Torre, Javier Ordoñez, and Juan Carlos de Agustin. 2019. “Digital Thoracic Drainage: A New System to Monitor Air Leaks in Pediatric Population”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2018.10.068.
- Cerfolio, Robert J., Gonzalo Varela, and Alessandro Brunelli. 2010. “Digital and Smart Chest Drainage Systems to Monitor Air Leaks: The Birth of a New Era?”. Thoracic Surgery Clinics. Elsevier BV. doi:10.1016/j.thorsurg.2010.03.007.
- Brunelli, Alessandro, Michele Salati, Cecilia Pompili, Majed Refai, and Armando Sabbatini. 2012. “Regulated Tailored Suction Vs Regulated Seal: A Prospective Randomized Trial on Air Leak Duration†”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezs518.
- Costa AD Jr, Bachichi T, Holanda C, Rizzo LA. An initial experience with a digital drainage system during the postoperative period of pediatric thoracic surgery. J Bras Pneumol. 2016 Nov-Dec;42(6):444-446. doi: 10.1590/S1806-37562016000000269.
- Munnell ER. Thoracic drainage. Ann Thorac Surg. 1997 May;63(5):1497-502. doi: 10.1016/s0003-4975(97)00082-9.
- Perez-Egido L, Garcia-Casillas MA, Simal I, Fanjul M, Canizo A, Cerda JA, Fernandez B, de la Torre M, Ordonez J, de Agustin JC. Digital thoracic drainage: a new system to monitor air leaks in pediatric population. J Pediatr Surg. 2019 Apr;54(4):693-695. doi: 10.1016/j.jpedsurg.2018.10.068. Epub 2018 Dec 19.
- Cerfolio RJ, Varela G, Brunelli A. Digital and smart chest drainage systems to monitor air leaks: the birth of a new era? Thorac Surg Clin. 2010 Aug;20(3):413-20. doi: 10.1016/j.thorsurg.2010.03.007.
- 2022. "Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05511987.
Frequently Asked Questions
Does this research endeavor accept participants who are 18 years of age or older?
"This research is targeting participants between the ages of 0 minutes and 17 years old." - Anonymous Online Contributor
How many participants are permitted to take part in this medical trial?
"Affirmative. Clinicaltrials.gov has the most up-to-date information, which indicates that this medical trial posted on August 15th 2022 is actively recruiting patients. 140 individuals will be accepted from a single site for study participation." - Anonymous Online Contributor
Am I suitable to participate in this experiment?
"For this medical trial, 140 participants between 0 minutes and 17 years old with air leakage must be recruited. In addition to the age requirement, all candidates must have undergone chest tube placement for spontaneous pneumothorax or pulmonary resection at The Children's Hospital by a surgeon (or in training)." - Anonymous Online Contributor
Are volunteers currently being accepted for this experiment?
"Affirmative, the information hosted on clinicaltrials.gov affirms that this trial is actively looking for participants. Initially posted on August 15th 2022 and most recently modified on August 19th 2022, the experiment seeks to recruit 140 individuals from 1 medical centre." - Anonymous Online Contributor