A Study to Evaluate Routine Chest Tube Management After Minimally Invasive Lung Surgery
NCT ID: NCT04913415
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
160 participants
INTERVENTIONAL
2021-02-23
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This research aims to compare two settings on a digital drainage system, a low suction (LS) mode - passive suction - and standard suction (ss) mode - active suction. From the data collected, the researchers will analyze whether LS or SS will lead to a better recovery after surgery.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Rise in Robotic Atypical Segmentectomies
NCT04644952
Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
NCT04067830
Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction
NCT03326570
Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
NCT00003831
Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer
NCT03347825
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Suction Strategy of Chest Tube Management
Low Suction Strategy of Chest Tube Management
A digital chest tube will be set to a low pressure mode (-8mmHg) during recovery after minimally invasive lung resection.
Standard Suction Strategy of Chest Tube Management
Standard Suction Strategy of Chest Tube Management
A digital chest tube will be to the standard suction mode (-20mmHg) during recovery after minimally invasive lung resection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low Suction Strategy of Chest Tube Management
A digital chest tube will be set to a low pressure mode (-8mmHg) during recovery after minimally invasive lung resection.
Standard Suction Strategy of Chest Tube Management
A digital chest tube will be to the standard suction mode (-20mmHg) during recovery after minimally invasive lung resection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients undergoing wedge resection to diagnose, or as definitive therapy for a lung nodule/cancer.
3. Able to understand and sign consent
Exclusion Criteria
2. Patients undergoing resection for inflammatory conditions such as aspergillosis
3. Patients undergoing diagnostic wedge resection for interstitial lung disease
4. Patients undergoing redo-VATS or thoracotomy on the same side as current planned resection
5. Patients found to have a "frozen chest" at the time of surgery, requiring extensive adhesiolysis,
6. Patients who are discovered to have metastatic disease during the operation, so that resection is no longer indicated.
7. Patients where a clinical decision to place more than one chest-tube is made
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hiran Fernando, MD
Chief of Thoracic Surgery at Allegheny General Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hiran Fernando, M.D.
Role: PRINCIPAL_INVESTIGATOR
Allegheny Health Network
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mayor MA, Khandhar SJ, Chandy J, Fernando HC. Implementing a thoracic enhanced recovery with ambulation after surgery program: key aspects and challenges. J Thorac Dis. 2018 Nov;10(Suppl 32):S3809-S3814. doi: 10.21037/jtd.2018.10.106.
Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
Cerfolio RJ, Bass C, Katholi CR. Prospective randomized trial compares suction versus water seal for air leaks. Ann Thorac Surg. 2001 May;71(5):1613-7. doi: 10.1016/s0003-4975(01)02474-2.
Marshall MB, Deeb ME, Bleier JI, Kucharczuk JC, Friedberg JS, Kaiser LR, Shrager JB. Suction vs water seal after pulmonary resection: a randomized prospective study. Chest. 2002 Mar;121(3):831-5. doi: 10.1378/chest.121.3.831.
Cerfolio RJ, Bryant AS. The benefits of continuous and digital air leak assessment after elective pulmonary resection: a prospective study. Ann Thorac Surg. 2008 Aug;86(2):396-401. doi: 10.1016/j.athoracsur.2008.04.016.
Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.
Brunelli 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.
Lijkendijk M, Licht PB, Neckelmann K. The Influence of Suction on Chest Drain Duration After Lobectomy Using Electronic Chest Drainage. Ann Thorac Surg. 2019 Jun;107(6):1621-1625. doi: 10.1016/j.athoracsur.2018.12.059. Epub 2019 Feb 8.
Holbek BL, Christensen M, Hansen HJ, Kehlet H, Petersen RH. The effects of low suction on digital drainage devices after lobectomy using video-assisted thoracoscopic surgery: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):673-681. doi: 10.1093/ejcts/ezy361.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.