Air LeakageTHOPAZNCT05511987
Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
A study testing Madela THOPAZ Digital Device and Atrium Analog Device in people with Air Leakage, run by University of Oklahoma at 1 site in United States.
Trial summary
In 2007 the Thopaz digital drainage system was launched as one of the first chest tube drainage systems to utilize a digital rather than analog device. The digital system allows for stored data, objective measurement of air leaks as well as maintaining a constant pleural pressure. Read more about this study
- Who is it for?
- Ages 0 minutes to 17 years
- Conditions the study is for
- Air Leakage
- What is being tested?
- Madela THOPAZ Digital Device and Atrium Analog Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 1 Dec 2027
- 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 0 minutes to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age≤17 years old
- requiring chest tube placement for spontaneous pneumothorax or pulmonary resection by a surgeon (or surgical trainee) at The Children's Hospital
Who cannot join
- age≥18-year-old
- chest tube placement by neonatologist or pediatrician,
- malignant pleural effusion
- re-operation or emergent operation
- pre-operative chemotherapy or radiation or history of chemotherapy or radiation within the past 12 months
- renal or hepatic failure
- neurological dysfunction
- empyema
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Catherine Hunter, MD, 405-271-8001 ext. 42477, catherine-hunter@ouhsc.edu
About this study
Official title: A Randomized Controlled Trial of a Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
In 2007 the Thopaz digital drainage system was launched as one of the first chest tube drainage systems to utilize a digital rather than analog device. The digital system allows for stored data, objective measurement of air leaks as well as maintaining a constant pleural pressure. The adult literature describes multiple benefits of using a digital drainage system, only two studies to date have looked at pediatric patients. In the adult literature, reported benefits include shorter chest tube drainage times, decreased length of stay, cost savings and fewer chest x-rays. To date, there have been no prospective randomized controlled trials comparing digital versus analog chest tube drainage systems in pediatric patients. In addition, the only two pediatric studies which looked at the potential benefits of a digital drainage system only looked at its use in patients who underwent pulmonary resection. Thus, a gap in the literature exists for a prospective trial determining if there is benefit to using a digital vs analog drainage system in pediatric patients requiring a chest tube. The investigators hypothesize that pediatric patients who are placed on the Thopaz+ digital drainage system will have decreased duration of chest tube drainage, fewer chest x-rays and shorter duration of air leaks compared to patients using a traditional analog chest tube drainage system. This will be the first prospective randomized study exploring the potential benefits of using a digital chest tube drainage system in pediatric patients.
Read the detailed description
This study will be a single site prospective randomized controlled study of all pediatric patients (age ≤17 years old) requiring a chest tube placed for spontaneous pneumothorax or pulmonary resection by a pediatric surgery fellow, faculty or general surgery faculty at The Children's Hospital at OU Health. Pediatric patients who meet inclusion criteria will be identified by pediatric surgery residents, fellows or staff. Upon receiving consent prior to chest tube placement, patients will be randomized to using either the digital (Thopaz+) or analog (Pleur-evac) drainage system. This is an investigator-initiated study. The investigators have designed and will conduct the study and keep the data. The company producing the digital or analog devices will not assist with the study design, conduct, data acquisition or monitoring, analysis or writing of the manuscript or abstracts. Patients will be followed while inpatient to determine duration of the chest tube drainage in days and hours, length of stay in days and time to first ambulation in days and hours. Time will start upon connecting the chest tube to the pre-determined drainage system. Additional data will be collected regarding when the patient was able to progress to water seal, therapeutic failure (defined as the need to replace chest tube after it was removed or placing an additional chest tube), complications (such as pneumonia), time to ambulation (in patients who were previously ambulating), number of chest x-rays, duration of the tube and presence of an air leak. An air leak will be defined as any bubbling in the water chamber of the analog device. Similarly, an air leak in the digital system will be defined as an air leak flow ≥10 ml/min. Accrual will continue until there are at least 12 patients in each arm of the study at which point interim analysis will be performed. Accrual will continue until an adequate sample size is obtained to power the study for both duration of chest tube and length of stay (N=70 per arm).
Stratified randomization will occur via permuted block with 2 strata (pulmonary resection or spontaneous pneumothorax) and a block size of 4. Randomization will be assigned via sealed envelopes designated as either pneumothorax or resection which when open will contain the group that the patient will be assigned to. Within the envelope there will be an assignment of group 1 (analog system) or group 2 (digital system). The sealed envelopes will be opened by the resident, fellow or faculty member after obtaining consent but before the chest tube is placed. Due to the nature of the device, the study will be unblinded for both the patient and investigators. The study will be analyzed via intention to treat. Sample size was calculated to detect a difference in duration of chest tube placement based on prior data (standard deviation=2.86). Based on 80% statistical power with an alpha=0.05, a sample size of 24 patients (12 patients in each arm) was determined.
Research will be conducted at The Children's Hospital at OU Health. Consenting will occur in clinic or at The Children's Hospital. Interventions will occur at The Children's Hospital (i.e. emergency department, inpatient rooms, neonatal or pediatric intensive care units etc). Individual research results will not be disclosed to participants. Identifiers might be removed and the de-identified information may be used for future research without additional informed consent from the subject.
- Conditions
- Air Leakage
- Being tested
- Madela THOPAZ Digital Device, Atrium Analog Device
- Keywords
- chest tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Madela THOPAZ Digital DeviceDevice
Digital drainage systems use electronic sensors to measure changes in pressure and thus may allow for quantification of the degree of air leak continuously and provide a graphical representation of the trend over time. Data on intrapleural pressure are also provided by some units. Together, these data may lead to expedited chest tube removal and hospital discharge with obvious financial implications.
Atrium Analog DeviceDevice
Analog drainage systems contain a sequentially numbered series of columns in the water seal chamber. The degree of air leak is assessed by observing the highest numbered column in which bubbling occurs. This provides a qualitative assessment at a specific point in time. This assessment, however, is subject to interobserver variability and does not account for variation over time.
| Study group | Role | What they receive |
|---|---|---|
| Madela THOPAZ Suction Pump | Active comparator | Digital chest tube drainage systems utilize sensors to objectively quantify the size of air leaks as well as adjust the amount of suction applied to the pleural cavity in order to maintain a constant negative pressure(4). Studies in the adult population have showed that using a digital system allows for objective criteria regarding when it is safe to remove the chest tube and thus decreased time of chest tube drainage. This has also translated into decreased length of stay and cost(2, 6-8). Early data suggests that these same benefits may apply to pediatric patients, however a prospective randomized trial comparing the two systems has not been performed(9, 10). Receives: Device: Madela THOPAZ Digital Device |
| Atrium Dry Suction Control Water Seal Chest Drain | Active comparator | there are several limitations to this analog system. First, although the system can manually be set to a certain negative pressure, the actual pressure experienced by the patient varies dependent on the amount of fluid in the tube and the level of the device relative to the patient(2). This leads to inconsistency of pleural pressure which has been associated with an increased incidence of prolonged air leak(2). Second, the analog system relies on a water chamber where bubbles are visualized to indicate an air leak. Air leaks are a common cause of increased duration of chest tube drainage and subsequent length of stay(3). There is high interobserver variability in the subjective measurement of air leaks when using the analog system thus exacerbating the amount of time the chest tube remains in the patient as well as the length of stay(4, 5). Receives: Device: Atrium Analog Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems.
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems will be compaired. The systems will be measured in cmH2O.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start15 Aug 2023
- Primary completionApr 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Air LeakageStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Hunter, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511987
- Sponsor's protocol ID
- 14196
- Acronym
- THOPAZ
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Munnell ER. Thoracic drainage. Ann Thorac Surg. 1997 May;63(5):1497-502. doi: 10.1016/s0003-4975(97)00082-9.
PubMed 9146363Lee SA, Kim JS, Chee HK, Hwang JJ, Ji M, Kim YH, Moon HJ, Lee WS. Clinical application of a digital thoracic drainage system for objectifying and quantifying air leak versus the traditional vacuum system: a retrospective observational study. J Thorac Dis. 2021 Feb;13(2):1020-1035. doi: 10.21037/jtd-20-2993.
PubMed 33717575Cerfolio 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.
PubMed 20619233Brunelli A, Salati M, Pompili C, Refai M, Sabbatini A. Regulated tailored suction vs regulated seal: a prospective randomized trial on air leak duration. Eur J Cardiothorac Surg. 2013 May;43(5):899-904. doi: 10.1093/ejcts/ezs518. Epub 2012 Sep 28.
PubMed 23024236Gilbert S, McGuire AL, Maghera S, Sundaresan SR, Seely AJ, Maziak DE, Shamji FM, Villeneuve PJ. Randomized trial of digital versus analog pleural drainage in patients with or without a pulmonary air leak after lung resection. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1243-9. doi: 10.1016/j.jtcvs.2015.08.051. Epub 2015 Aug 28.
PubMed 26409729Jablonski S, Brocki M, Wawrzycki M, Smigielski JA, Kozakiewicz M. Efficacy assessment of the drainage with permanent airflow measurement in the treatment of pneumothorax with air leak. Thorac Cardiovasc Surg. 2014 Sep;62(6):509-15. doi: 10.1055/s-0033-1359714. Epub 2013 Dec 2.
PubMed 24297633Costa 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.
PubMed 28117476Perez-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.
PubMed 30658842
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05511987
- Acronym / sponsor ID
- THOPAZ / 14196
- Conditions
- Air Leakage
- Keywords
- chest tube
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Aug 2022 (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.
In 2007 the Thopaz digital drainage system was launched as one of the first chest tube drainage systems to utilize a digital rather than analog device. The digital system allows for stored data, objective measurement of air leaks as well as maintaining a constant pleural pressure. The adult literature describes multiple benefits of using a digital drainage system, only two studies to date have looked at pediatric patients. In the adult literature, reported benefits include shorter chest tube drainage times, decreased length of stay, cost savings and fewer chest x-rays. To date, there have been no prospective randomized controlled trials comparing digital versus analog chest tube drainage systems in pediatric patients. In addition, the only two pediatric studies which looked at the potential benefits of a digital drainage system only looked at its use in patients who underwent pulmonary resection. Thus, a gap in the literature exists for a prospective trial determining if there is benefit to using a digital vs analog drainage system in pediatric patients requiring a chest tube. The investigators hypothesize that pediatric patients who are placed on the Thopaz+ digital drainage system will have decreased duration of chest tube drainage, fewer chest x-rays and shorter duration of air leaks compared to patients using a traditional analog chest tube drainage system. This will be the first prospective randomized study exploring the potential benefits of using a digital chest tube drainage system in pediatric patients.
Detailed description
This study will be a single site prospective randomized controlled study of all pediatric patients (age ≤17 years old) requiring a chest tube placed for spontaneous pneumothorax or pulmonary resection by a pediatric surgery fellow, faculty or general surgery faculty at The Children's Hospital at OU Health. Pediatric patients who meet inclusion criteria will be identified by pediatric surgery residents, fellows or staff. Upon receiving consent prior to chest tube placement, patients will be randomized to using either the digital (Thopaz+) or analog (Pleur-evac) drainage system. This is an investigator-initiated study. The investigators have designed and will conduct the study and keep the data. The company producing the digital or analog devices will not assist with the study design, conduct, data acquisition or monitoring, analysis or writing of the manuscript or abstracts. Patients will be followed while inpatient to determine duration of the chest tube drainage in days and hours, length of stay in days and time to first ambulation in days and hours. Time will start upon connecting the chest tube to the pre-determined drainage system. Additional data will be collected regarding when the patient was able to progress to water seal, therapeutic failure (defined as the need to replace chest tube after it was removed or placing an additional chest tube), complications (such as pneumonia), time to ambulation (in patients who were previously ambulating), number of chest x-rays, duration of the tube and presence of an air leak. An air leak will be defined as any bubbling in the water chamber of the analog device. Similarly, an air leak in the digital system will be defined as an air leak flow ≥10 ml/min. Accrual will continue until there are at least 12 patients in each arm of the study at which point interim analysis will be performed. Accrual will continue until an adequate sample size is obtained to power the study for both duration of chest tube and length of stay (N=70 per arm).
Stratified randomization will occur via permuted block with 2 strata (pulmonary resection or spontaneous pneumothorax) and a block size of 4. Randomization will be assigned via sealed envelopes designated as either pneumothorax or resection which when open will contain the group that the patient will be assigned to. Within the envelope there will be an assignment of group 1 (analog system) or group 2 (digital system). The sealed envelopes will be opened by the resident, fellow or faculty member after obtaining consent but before the chest tube is placed. Due to the nature of the device, the study will be unblinded for both the patient and investigators. The study will be analyzed via intention to treat. Sample size was calculated to detect a difference in duration of chest tube placement based on prior data (standard deviation=2.86). Based on 80% statistical power with an alpha=0.05, a sample size of 24 patients (12 patients in each arm) was determined.
Research will be conducted at The Children's Hospital at OU Health. Consenting will occur in clinic or at The Children's Hospital. Interventions will occur at The Children's Hospital (i.e. emergency department, inpatient rooms, neonatal or pediatric intensive care units etc). Individual research results will not be disclosed to participants. Identifiers might be removed and the de-identified information may be used for future research without additional informed consent from the subject.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Madela THOPAZ Suction Pump | Active comparator | Device: Madela THOPAZ Digital DeviceDigital chest tube drainage systems utilize sensors to objectively quantify the size of air leaks as well as adjust the amount of suction applied to the pleural cavity in order to maintain a constant negative pressure(4). Studies in the adult population have showed that using a digital system allows for objective criteria regarding when it is safe to remove the chest tube and thus decreased time of chest tube drainage. This has also translated into decreased length of stay and cost(2, 6-8). Early data suggests that these same benefits may apply to pediatric patients, however a prospective randomized trial comparing the two systems has not been performed(9, 10). |
| Atrium Dry Suction Control Water Seal Chest Drain | Active comparator | Device: Atrium Analog Devicethere are several limitations to this analog system. First, although the system can manually be set to a certain negative pressure, the actual pressure experienced by the patient varies dependent on the amount of fluid in the tube and the level of the device relative to the patient(2). This leads to inconsistency of pleural pressure which has been associated with an increased incidence of prolonged air leak(2). Second, the analog system relies on a water chamber where bubbles are visualized to indicate an air leak. Air leaks are a common cause of increased duration of chest tube drainage and subsequent length of stay(3). There is high interobserver variability in the subjective measurement of air leaks when using the analog system thus exacerbating the amount of time the chest tube remains in the patient as well as the length of stay(4, 5). |
Who may qualify
- Ages
- 0 minutes to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age≤17 years old
- requiring chest tube placement for spontaneous pneumothorax or pulmonary resection by a surgeon (or surgical trainee) at The Children's Hospital
Key exclusion criteria (8 listed)
- age≥18-year-old
- chest tube placement by neonatologist or pediatrician,
- malignant pleural effusion
- re-operation or emergent operation
- pre-operative chemotherapy or radiation or history of chemotherapy or radiation within the past 12 months
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 |
|---|---|---|
| Madela THOPAZ Digital DeviceDigital drainage systems use electronic sensors to measure changes in pressure and thus may allow for quantification of the degree of air leak continuously and provide a graphical representation of the trend over time. Data on intrapleural pressure are also provided by some units. Together, these data may lead to expedited chest tube removal and hospital discharge with obvious financial implications. | Device | Madela THOPAZ Suction Pump |
| Atrium Analog DeviceAnalog drainage systems contain a sequentially numbered series of columns in the water seal chamber. The degree of air leak is assessed by observing the highest numbered column in which bubbling occurs. This provides a qualitative assessment at a specific point in time. This assessment, however, is subject to interobserver variability and does not account for variation over time. | Device | Atrium Dry Suction Control Water Seal Chest Drain |
Primary outcome
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems.
Time frame: 2 years
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems will be compaired. The systems will be measured in cmH2O.
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 1 Apr 2026.
- Background: PubMed 9146363Munnell ER. Thoracic drainage. Ann Thorac Surg. 1997 May;63(5):1497-502. doi: 10.1016/s0003-4975(97)00082-9.
- Background: PubMed 33717575Lee SA, Kim JS, Chee HK, Hwang JJ, Ji M, Kim YH, Moon HJ, Lee WS. Clinical application of a digital thoracic drainage system for objectifying and quantifying air leak versus the traditional vacuum system: a retrospective observational study. J Thorac Dis. 2021 Feb;13(2):1020-1035. doi: 10.21037/jtd-20-2993.
- Background: PubMed 20619233Cerfolio 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.
- Background: PubMed 23024236Brunelli A, Salati M, Pompili C, Refai M, Sabbatini A. Regulated tailored suction vs regulated seal: a prospective randomized trial on air leak duration. Eur J Cardiothorac Surg. 2013 May;43(5):899-904. doi: 10.1093/ejcts/ezs518. Epub 2012 Sep 28.
- Background: PubMed 26409729Gilbert S, McGuire AL, Maghera S, Sundaresan SR, Seely AJ, Maziak DE, Shamji FM, Villeneuve PJ. Randomized trial of digital versus analog pleural drainage in patients with or without a pulmonary air leak after lung resection. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1243-9. doi: 10.1016/j.jtcvs.2015.08.051. Epub 2015 Aug 28.
- Background: PubMed 24297633Jablonski S, Brocki M, Wawrzycki M, Smigielski JA, Kozakiewicz M. Efficacy assessment of the drainage with permanent airflow measurement in the treatment of pneumothorax with air leak. Thorac Cardiovasc Surg. 2014 Sep;62(6):509-15. doi: 10.1055/s-0033-1359714. Epub 2013 Dec 2.
- Background: PubMed 28117476Costa 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.
- Background: PubMed 30658842Perez-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.
- Individual participant dataSharing planned: No
Related trials for Air Leakage
RecruitingObservational study
Prolonged Hospital Stay After Thoracoscopic Anatomical Lung Resections
Minimally Invasive Surgical Procedures, VATS
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.
Catherine Hunter, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Madela THOPAZ Digital Device and Atrium Analog Device in people with Air Leakage, run by University of Oklahoma at 1 site in United States.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Apr 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 United States. 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?
Contact Catherine Hunter, MD (2718001 ext. 42477, catherine-hunter@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems. (time frame: 2 years). 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 NCT05511987, which also lists 8 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 1 Apr 2026.