Traumatic PneumothoraxNCT04986527
Duration of Chest Tube Suction in Traumatic Pneumothorax
A study testing Chest tube suction in people with Traumatic Pneumothorax, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic pneumothorax. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Pneumothorax
- What is being tested?
- Chest tube suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trauma service consult/patient
- Traumatic pneumothorax with chest tube placed within 0-24 hours of presentation and confirmation of adequate position
- Age >18
- Blunt or penetrating mechanism
- Chest tubes sizes 14 to 32Fr
- Chest tubes placed by residents on the trauma surgery service supervised by attending trauma surgeons or placed by the attending surgeon themselves
- Presence of single chest tube in one or both pleural cavities (single unilateral or bilateral tubes)
- Subjects with decision making capacity (DMC) who are able to provide written consent. DMC will be determined by the consenting physician through a teach back mechanism. Subjects must demonstrate understanding of the situation, appreciation of the consequences of their decision, reasoning of their thought process, and be able to communicate their wishes.
Who cannot join
- Age <18
- Pregnant patients
- Prisoners
- Mechanically ventilated in ICU for more than 24 hours while chest tube in place
- Chest tubes placed as part of, or present during, a thoracic operation
- History of surgery involving pleural cavity ipsilateral to chest tube
Show all 11Show fewer
- Subjects with more than one chest tube on the ipsilateral side at any time prior to study chest tube removal
- Subjects with chylothorax or empyema
- Subjects with chest tubes that are withdrawn or removed unintentionally
- Subjects with known or suspected bronchial injury
- Subjects with bullous emphysema.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Chest Tube Management in Traumatic Pneumothorax: Does Duration of Suction Matter
The purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic pneumothorax.
- Conditions
- Traumatic Pneumothorax
- Being tested
- Chest tube suction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest tube suctionProcedure or surgery
The chest tubes will be inserted using our institutional standard chest tube insertion tray. The chest tubes used will be our institutional standard and will range from 14 to 32Fr in size. After chest tube placement, an Atrium Oasis Dry Suction Water Seal Chest Drain (Getinge USA Sales, LLC) will be used.
| Study group | Role | What they receive |
|---|---|---|
| 24 hours of suction | Active comparator | Subjects with chest tubes kept to -20 cmH2O suction for 24 hours prior to water seal Receives: Procedure: Chest tube suction |
| 48 hours of suction | Experimental | Subjects with chest tubes kept to -20 cmH2O suction for 48 hours prior to water seal Receives: Procedure: Chest tube suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube dwell time
Total time that chest tube is in place from insertion to removal
Measured: up to 1 month
Secondary outcomes (5)
Number of participants with reaccumulation of pneumothorax
After transition to water seal and stopping suction, incidence of reaccumulation of pneumothorax requiring suction or replacement of chest tube.
Measured: up to 3 days
Number of participants with at least one pulmonary complications
Pulmonary complications are defined as increased oxygen requirements, shortness of breath or unplanned intubations following placement to suction.
Measured: up to 1 week
Readmission to hospital
Number of participants readmitted to the hospital within 30 days
Measured: 30 days
Transfer to ICU
Number of participants with an unplanned transfer to the intensive care unit
Measured: up to 1 week
Median length of stay
Median length of stay in the hospital after chest tube placement
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Why it stopped: study does not have funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic PneumothoraxStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J Nabozny, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986527
- Sponsor's protocol ID
- STUDY00005364
- Status last verified
- Mar 2022
- First submitted
- 22 Jul 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Tube Management in Traumatic Pneumothorax: Does Duration of Suction Matter
- ClinicalTrials.gov ID
- NCT04986527
- Acronym / sponsor ID
- STUDY00005364
- Conditions
- Traumatic Pneumothorax
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study does not have funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 3 Aug 2021 (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.
The purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic pneumothorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 hours of suction | Active comparator | Procedure: Chest tube suctionSubjects with chest tubes kept to -20 cmH2O suction for 24 hours prior to water seal |
| 48 hours of suction | Experimental | Procedure: Chest tube suctionSubjects with chest tubes kept to -20 cmH2O suction for 48 hours prior to water seal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Trauma service consult/patient
- Traumatic pneumothorax with chest tube placed within 0-24 hours of presentation and confirmation of adequate position
- Age >18
- Blunt or penetrating mechanism
- Chest tubes sizes 14 to 32Fr
Key exclusion criteria (11 listed)
- Age <18
- Pregnant patients
- Prisoners
- Mechanically ventilated in ICU for more than 24 hours while chest tube in place
- Chest tubes placed as part of, or present during, a thoracic operation
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 |
|---|---|---|
| Chest tube suctionThe chest tubes will be inserted using our institutional standard chest tube insertion tray. The chest tubes used will be our institutional standard and will range from 14 to 32Fr in size. After chest tube placement, an Atrium Oasis Dry Suction Water Seal Chest Drain (Getinge USA Sales, LLC) will be used. | Procedure or surgery | 24 hours of suction, 48 hours of suction |
Primary outcome
Chest tube dwell time
Time frame: up to 1 month
Total time that chest tube is in place from insertion to removal
5 secondary outcomes
Number of participants with reaccumulation of pneumothorax
Time frame: up to 3 days
Number of participants with at least one pulmonary complications
Time frame: up to 1 week
Readmission to hospital
Time frame: 30 days
Transfer to ICU
Time frame: up to 1 week
Median length of stay
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest tube suction in people with Traumatic Pneumothorax, run by University of Rochester 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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 29 Mar 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Chest tube dwell time (time frame: up to 1 month). 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 29 Mar 2022.