Lung CancerNCT01551082
Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes
An observational study of Lung Cancer and Pneumothorax, run by Alliance of Cardiothoracic and Vascular Surgeons at 1 site in United States.
Trial summary
Discharging patients home with air leak and chest tube to portable drainage device after thoracic resection is cost effective and safe without compromising patients outcome or satisfaction. Despite good outcomes this practice is not done universally by thoracic surgeons. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Pneumothorax, Subcutaneous Emphysema
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jan 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing thoracic resection by one surgeon with post operative air leak being discharged home with chest tube and portable drainage device.
Who may be able to join
- all patients 18-89,
- all genders,
- all patients undergoing thoracic resection,
- all patients discharged with chest tube
Who cannot join
- minors,
- all patients > 90 years old,
- all mentally challenged,
- all non-English speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Discharging patients home with air leak and chest tube to portable drainage device after thoracic resection is cost effective and safe without compromising patients outcome or satisfaction. Despite good outcomes this practice is not done universally by thoracic surgeons.
Read the detailed description
Medical chart database to identify patients ,of one thoracic surgeon over the last seven years, who underwent thoracic resection and were discharged home with an air leak and chest tube to portable drainage device was completed. Once all patients were identified, all possible vulnerable patients were discarded. Written consent for participation was obtained by eligible patients and subjects willing to participate were given further explanation of the study. All willing participants completed an Outpatient Chest Tube Quality of Life Questionnaire. Upon completion of the questionnaire participants involvement in the study was complete. Data was collected and correlations between variables statistically analysed to determine significant factors affecting care.
- Conditions
- Lung Cancer, Pneumothorax, Subcutaneous Emphysema
- Medical subject headings
- Lung Neoplasms, Pneumothorax, Subcutaneous Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient chest tubes | All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes
Outcome measures for this study were to correlate outpatient chest tube management with patient satisfaction. Also to correlate decreased length of stay without compromising any patient outcomes.
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 posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance of Cardiothoracic and Vascular Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Smith, Alliance of Cardiothoracic and Vascular Surgeons
- Investigators
- Jeremy S Smith, BSN, Principal investigator, Alliance of Cardiac Thoracic and Vascular Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551082
- Sponsor's protocol ID
- MEM Chest tube study
- Status last verified
- Oct 2016
- First submitted
- 8 Mar 2012
- Last updated
- 12 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes
- ClinicalTrials.gov ID
- NCT01551082
- Acronym / sponsor ID
- MEM Chest tube study
- Conditions
- Lung Cancer, Pneumothorax, Subcutaneous Emphysema
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alliance of Cardiothoracic and Vascular SurgeonsUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Discharging patients home with air leak and chest tube to portable drainage device after thoracic resection is cost effective and safe without compromising patients outcome or satisfaction. Despite good outcomes this practice is not done universally by thoracic surgeons.
Detailed description
Medical chart database to identify patients ,of one thoracic surgeon over the last seven years, who underwent thoracic resection and were discharged home with an air leak and chest tube to portable drainage device was completed. Once all patients were identified, all possible vulnerable patients were discarded. Written consent for participation was obtained by eligible patients and subjects willing to participate were given further explanation of the study. All willing participants completed an Outpatient Chest Tube Quality of Life Questionnaire. Upon completion of the questionnaire participants involvement in the study was complete. Data was collected and correlations between variables statistically analysed to determine significant factors affecting care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient chest tubes | – | –All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing thoracic resection by one surgeon with post operative air leak being discharged home with chest tube and portable drainage device.
Key inclusion criteria (4 listed)
- all patients 18-89,
- all genders,
- all patients undergoing thoracic resection,
- all patients discharged with chest tube
Key exclusion criteria (4 listed)
- minors,
- all patients > 90 years old,
- all mentally challenged,
- all non-English speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes
Time frame: 2 years
Outcome measures for this study were to correlate outpatient chest tube management with patient satisfaction. Also to correlate decreased length of stay without compromising any patient outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jeremy S Smith, BSN principal investigator
Alliance of Cardiac Thoracic and Vascular Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Pneumothorax, run by Alliance of Cardiothoracic and Vascular Surgeons 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Dec 2016. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2016.