PneumothoraxNCT02528734
Prospective Evaluation of Needle Exsufflation for Pneumothorax
An observational study of Pneumothorax, run by Hôpital Louis Mourier at 1 site in France.
Trial summary
Monocentric observational study of needle exsufflation for pneumothorax in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Nov 2016
- Phase
- Observational
- 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
Study population: adult patients admitted to the ICU with a pneumothorax
Who may be able to join
- adult ICU patients requiring needle exsufflation for spontaneous pneumothorax
Who cannot join
- refuse to participate
- contraindications to needle exsufflation (acute respiratory failure requiring immediate chest tube insertion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Pneumothorax Duration Before Treatment on the Success of Needle Exsufflation
Monocentric observational study of needle exsufflation for pneumothorax in the ICU.
Read the detailed description
The main objective of this prospective observational non interventional study is to investigate a possible relationship between prior duration of pneumothorax (defined as the duration from first occurence of chest pain reported by patient to exsufflation) and the success of exsufflation procedure (defined by the absence of a chest tube insertion in the following 24h).
- Conditions
- Pneumothorax
- Keywords
- pneumothorax
- Medical subject headings
- Pneumothorax
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with early success of needle exsufflation
success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation
Measured: 24 hrs
Number of patients with early success of needle exsufflation with duration of symptoms prior to exsufflation greater than 48 hrs
success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation; duration of symptoms prior to exsufflation is the time (in hrs) elapsed between first chest pain reported by the patient and needle exsufflation
Measured: 24 hrs
Secondary outcomes (4)
Length of ICU stay
participants will be followed for the duration of ICU stay, from ICU admission to ICU discharge, an expected average of 8 days
Measured: 8 days
Length of hospital stay
participants will be followed for the duration of hospital stay, from hospital admission to hospital discharge, an expected average of 15 days
Measured: 15 days
Number of patients requiring early surgical pleurodesis because of persistent pneumothorax
Patients will be monitored for eventual need for surgical pleurodesis during their ICU stay because of persistent or worsening pneumothorax
Measured: 8 days
Number of patients with late exsufflation failure
late exsufflation failure is defined as patients requiring chest tube insertion at least 24 hrs after needle exsufflation because of persistent or worsening of pneumothorax despite initial early success
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies 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
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Louis Mourier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Jean-Damien RICARD, Hôpital Louis Mourier
- Investigators
- Ricard Jean-Damien, MD, PhD, Study director, Hopital Louis Mourier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528734
- Sponsor's protocol ID
- HLM_JDR5
- Status last verified
- Sep 2017
- First submitted
- 17 Aug 2015
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available.
PubMed 20696690Andrivet P, Djedaini K, Teboul JL, Brochard L, Dreyfuss D. Spontaneous pneumothorax. Comparison of thoracic drainage vs immediate or delayed needle aspiration. Chest. 1995 Aug;108(2):335-9. doi: 10.1378/chest.108.2.335.
PubMed 7634863Vuillard C, Dib F, Achamlal J, Gaudry S, Roux D, Chemouny M, Javaud N, Dreyfuss D, Ricard JD, Messika J. Longer symptom onset to aspiration time predicts success of needle aspiration in primary spontaneous pneumothorax. Thorax. 2019 Aug;74(8):780-786. doi: 10.1136/thoraxjnl-2019-213168. Epub 2019 Jun 12.
PubMed 31189731
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pneumothorax Duration Before Treatment on the Success of Needle Exsufflation
- ClinicalTrials.gov ID
- NCT02528734
- Acronym / sponsor ID
- HLM_JDR5
- Conditions
- Pneumothorax
- Keywords
- pneumothorax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hôpital Louis MourierUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Aug 2015 (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.
Monocentric observational study of needle exsufflation for pneumothorax in the ICU.
Detailed description
The main objective of this prospective observational non interventional study is to investigate a possible relationship between prior duration of pneumothorax (defined as the duration from first occurence of chest pain reported by patient to exsufflation) and the success of exsufflation procedure (defined by the absence of a chest tube insertion in the following 24h).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients admitted to the ICU with a pneumothorax
Key inclusion criteria (1 listed)
- adult ICU patients requiring needle exsufflation for spontaneous pneumothorax
Key exclusion criteria (2 listed)
- refuse to participate
- contraindications to needle exsufflation (acute respiratory failure requiring immediate chest tube insertion)
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
Number of patients with early success of needle exsufflation
Time frame: 24 hrs
success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation
Number of patients with early success of needle exsufflation with duration of symptoms prior to exsufflation greater than 48 hrs
Time frame: 24 hrs
success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation; duration of symptoms prior to exsufflation is the time (in hrs) elapsed between first chest pain reported by the patient and needle exsufflation
4 secondary outcomes
Length of ICU stay
Time frame: 8 days
Length of hospital stay
Time frame: 15 days
Number of patients requiring early surgical pleurodesis because of persistent pneumothorax
Time frame: 8 days
Number of patients with late exsufflation failure
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Background: PubMed 20696690MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available.
- Results publication: PubMed 7634863Andrivet P, Djedaini K, Teboul JL, Brochard L, Dreyfuss D. Spontaneous pneumothorax. Comparison of thoracic drainage vs immediate or delayed needle aspiration. Chest. 1995 Aug;108(2):335-9. doi: 10.1378/chest.108.2.335.
- Derived from this study: PubMed 31189731Vuillard C, Dib F, Achamlal J, Gaudry S, Roux D, Chemouny M, Javaud N, Dreyfuss D, Ricard JD, Messika J. Longer symptom onset to aspiration time predicts success of needle aspiration in primary spontaneous pneumothorax. Thorax. 2019 Aug;74(8):780-786. doi: 10.1136/thoraxjnl-2019-213168. Epub 2019 Jun 12.
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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.
Ricard Jean-Damien, MD, PhD study director
Hopital Louis Mourier
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 Pneumothorax, run by Hôpital Louis Mourier at 1 site in France.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Sep 2017. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with early success of needle exsufflation (time frame: 24 hrs). The study lists 2 primary outcomes in all. 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 NCT02528734, which also lists 3 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 20 Sep 2017.