Traumatic PneumothoraxPhase 3NCT01537289
Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax
A Phase 3 study testing Pigtail catheter insertion (Cook) and chest tube (28-French) in people with Traumatic Pneumothorax, run by University of Arizona at 1 site in United States.
Trial summary
A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax. There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Pneumothorax
- What is being tested?
- Pigtail catheter insertion (Cook) and chest tube (28-French)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2012
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old and above
- Suffer traumatic pneumothorax that requires chest tube insertion
Who cannot join
- Emergency chest tube insertion
- patient refuses
- patient is unable to provide or rate pain assessment
- prisoner
- pregnancy
- patient with GCS less than 13
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Ariznoa Medican Center, Main campus
Tucson, Arizona, 85724
Narong Kulvatunyou, MD, 520-626-6302, nkulvatunyou@surgery.arizona.edu
Coy Collins, RN, 520-626-2876, ccollins@surgery.arizona.edu
About this study
Official title: A Prospective Randomized Study of 14-French (14F) Pigtail Catheters Versus 28F Chest Tubes in Patients With Traumatic Pneumothorax: Impact on Tube-Site Pain and Failure Rate
A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.
There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT.
Read the detailed description
Primary outcome: - Tube site pain
- Pain medication requirement
Secondary outcome: failure rate insertion-related complication
- Conditions
- Traumatic Pneumothorax
- Being tested
- Pigtail catheter insertion (Cook), chest tube (28-French)
- Keywords
- Trauma, Pneumothorax
- Medical subject headings
- Wounds and Injuries, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pigtail catheter insertion (Cook)Device
Also called Cook Critical Care, Cook Incorporated, Bloomington, IN)
insertion of pigtail catheter to decompress pneumothorax
chest tube (28-French)Device
Also called 28-French chest tube
inserting chest tube to decompress pneumothorax
| Study group | Role | What they receive |
|---|---|---|
| Pigtail catheter | Experimental | Not described Receives: Device: Pigtail catheter insertion (Cook) |
| Traditional chest tube | Active comparator | 28-French chest tube Receives: Device: chest tube (28-French) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tube-site pain, pain medication requirement
Measured: day 0, 1, 2
Secondary outcomes (2)
failure rate
Measured: patients will be followed for the duration of hospital stay, an expected average of 2 weeks
Insertion-related complication
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJul 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic PneumothoraxStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narong Kulvatunyou, University of Arizona
- Investigators
- narong kulvatunyou, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537289
- Sponsor's protocol ID
- 10-0405-03
- Status last verified
- Feb 2012
- First submitted
- 9 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kulvatunyou N, Erickson L, Vijayasekaran A, Gries L, Joseph B, Friese RF, O'Keeffe T, Tang AL, Wynne JL, Rhee P. Randomized clinical trial of pigtail catheter versus chest tube in injured patients with uncomplicated traumatic pneumothorax. Br J Surg. 2014 Jan;101(2):17-22. doi: 10.1002/bjs.9377.
PubMed 24375295
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of 14-French (14F) Pigtail Catheters Versus 28F Chest Tubes in Patients With Traumatic Pneumothorax: Impact on Tube-Site Pain and Failure Rate
- ClinicalTrials.gov ID
- NCT01537289
- Acronym / sponsor ID
- 10-0405-03
- Conditions
- Traumatic Pneumothorax
- Keywords
- Trauma, Pneumothorax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 23 Feb 2012 (estimated)
- 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.
A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.
There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT.
Detailed description
Primary outcome: - Tube site pain
- Pain medication requirement
Secondary outcome: failure rate insertion-related complication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pigtail catheter | Experimental | Device: Pigtail catheter insertion (Cook) |
| Traditional chest tube | Active comparator | Device: chest tube (28-French)28-French chest tube |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old and above
- Suffer traumatic pneumothorax that requires chest tube insertion
Key exclusion criteria (6 listed)
- Emergency chest tube insertion
- patient refuses
- patient is unable to provide or rate pain assessment
- prisoner
- pregnancy
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 |
|---|---|---|
| Pigtail catheter insertion (Cook)Also: Cook Critical Care, Cook Incorporated, Bloomington, IN)insertion of pigtail catheter to decompress pneumothorax | Device | Pigtail catheter |
| chest tube (28-French)Also: 28-French chest tubeinserting chest tube to decompress pneumothorax | Device | Traditional chest tube |
Primary outcome
Change in Tube-site pain, pain medication requirement
Time frame: day 0, 1, 2
2 secondary outcomes
failure rate
Time frame: patients will be followed for the duration of hospital stay, an expected average of 2 weeks
Insertion-related complication
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
- Derived from this study: PubMed 24375295Kulvatunyou N, Erickson L, Vijayasekaran A, Gries L, Joseph B, Friese RF, O'Keeffe T, Tang AL, Wynne JL, Rhee P. Randomized clinical trial of pigtail catheter versus chest tube in injured patients with uncomplicated traumatic pneumothorax. Br J Surg. 2014 Jan;101(2):17-22. doi: 10.1002/bjs.9377.
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.
University of Ariznoa Medican Center, Main campus
Tucson, United States
narong kulvatunyou, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pigtail catheter insertion (Cook) and chest tube (28-French) in people with Traumatic Pneumothorax, run by University of Arizona 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 6 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: status not confirmed, as of the sponsor's last update on 23 Feb 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tube-site pain, pain medication requirement (time frame: day 0, 1, 2). 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 NCT01537289, which also lists 1 linked publication.
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 23 Feb 2012.