Pneumothorax Spontaneous PrimaryPNEUM-AMBUNCT03691480
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
A study testing Fuhrman catheter insertion, Three-way stopcock open and Manual aspiration in people with Pneumothorax Spontaneous Primary, run by Rennes University Hospital at 5 sites in France.
Trial summary
The management of large spontaneous pneumothorax is not consensual. Current practice involves placement of a Fuhrman catheter connected to a one-way valve, with outpatient monitoring in pneumology consultation. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pneumothorax Spontaneous Primary
- What is being tested?
- Fuhrman catheter insertion, Three-way stopcock open and Manual aspiration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 5 sitesFrance
- Study dates
- 17 Sep 2021to 16 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Episode of large unilateral primary spontaneous pneumothorax according to British Thoracic Society (BTS), American College of Chest Physicians (ACCP) and/or French guidelines, defined as : a separation of ≥ 2 cm at the hilum, and/or ≥ 3 cm at the apex, and/or ≥ 2 cm over the whole height on an axillary view
- Free and informed consent of the patient
Who cannot join
- Impossibility of ambulatory management, at the clinician's discretion
- Inability to follow or understand the study procedures
- Secondary pneumothorax, i.e. associated with an underlying chronic respiratory disease such as chronic obstructive pulmonary disease (COPD), emphysema, asthma, cystic fibrosis or pulmonary fibrosis
- Non-spontaneous pneumothorax: traumatic or iatrogenic
- Protected persons: adults under legal protection (judicial protection, curatorship or guardianship), persons deprived of liberty, pregnant women (self-reported), breastfeeding women, and minors
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre 02 - Groupe Hospitalier de Bretagne Sud, Hôpital du Scorff
Lorient
Centre 01 - CHU de RENNES, Hôpital Pontchaillou
Rennes
Centre 04 - GHSO, CH Selestat
Sélestat
Centre 03 - GHRE, CH Saint-Malo
St-Malo
Centre 05 - CHU Toulouse, Hôpital Larrey
Toulouse
About this study
The management of large spontaneous pneumothorax is not consensual. Current practice involves placement of a Fuhrman catheter connected to a one-way valve, with outpatient monitoring in pneumology consultation. Manual aspiration is a widely used alternative, but the two approaches have never been directly compared in a prospective study.
The main objective of this randomized trial is to compare the efficacy of these two ambulatory strategies in adults with an episode of large unilateral primary spontaneous pneumothorax. We hypothesize that management with a Fuhrman catheter and one-way valve is superior to manual aspiration.
Read the detailed description
This is a multicenter, randomized, open-label, parallel-group superiority trial. Eligible patients are adults (between 18 years old and 50 years old) presenting to the emergency department of a participating center with a large unilateral primary spontaneous pneumothorax. After information and written consent, patients are randomized on Day 0 to one of two arms :
- ambulatory management with pigtail catheter connected to one-way valve as previously published (Voisin F et al. Ann Emerg Med 2014; Sale A et al. Respir Med 2020) or
- manual aspiration as described in international guidelines.
Large pneumothorax is defined according to BTS, ACCP and/or French guidelines as a separation of ≥ 2 cm at the hilum, and/or ≥ 3 cm at the apex, and/or ≥ 2 cm over the whole height on an axillary view. Complete or near-complete re-expansion means a residual pneumothorax below these thresholds; otherwise the pneumothorax is considered persistent.
In both arms, failure is defined as hospitalization. In the manual aspiration arm, it also includes switching to the one-way valve arm (circuit reopened, valve connected), which is immediate (Day 0, Hour 0) if an aspirated volume of ≥ 2 L (40 syringes) is reached. The patient then receives usual care.
- Other data collected. All patients are seen on Day 2, Day 6 and, if needed, Day 4, with a standard pulmonology history and clinical examination. Pain and analgesic consumption are recorded daily from Day 1 to Day 6, together with adverse events. Pain is also assessed at catheter removal.
- Long-term follow-up. Patients are contacted at Months 3, 6, 9 and 12 to document pneumothorax recurrence and pleurodesis.
- Previous inclusion / Repeat episodes Patients already included in this study for a previous large PSP episode are not eligible.
- Conditions
- Pneumothorax Spontaneous Primary
- Being tested
- Fuhrman catheter insertion, Three-way stopcock open, Manual aspiration
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuhrman catheter insertionProcedure or surgery
8.5 French Fuhrman catheter insertion using the Seldinger technique, connected to a three-way stopcock and a one-way valve
Three-way stopcock openProcedure or surgery
Opening of the three-way stopcock on Day 0 to connect the Fuhrman catheter to the one-way valve
Manual aspirationProcedure or surgery
Manual aspiration through the Fuhrman catheter with a 50 mL syringe through the Fuhrman catheter on Day 0, followed by closure of the three-way stopcock (optional second aspiration).
| Study group | Role | What they receive |
|---|---|---|
| One-way valve | Active comparator | Ambulatory management with the Fuhrman catheter connected to a one-way valve, with chest X-ray follow-up on Day 0, Day 2, Day 4 if needed, and Day 6. Receives: Procedure: Fuhrman catheter insertion; Procedure: Three-way stopcock open |
| Manual aspiration | Experimental | Manual aspiration with 50 mL syringes through the Fuhrman catheter on Day 0 (optional second aspiration), followed by closure of the three-way stopcock, with chest X-rays at Hour 4, Hour 8 (if applicable), Day 2 and Day 6. An aspirated volume ≥ 2 L (40 syringes), a persistent large pneumothorax after the last aspiration or on Day 2 leads to reopening of the circuit and connection of the one-way valve (failure). Receives: Procedure: Fuhrman catheter insertion; Procedure: Manual aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful ambulatory management
Success is assessed for each patient at Day 6 and is defined as complete or near-complete lung re-expansion on the Day 6 chest X-ray, without hospitalization decided by the treating physician and, in the manual aspiration arm, without change of arm (reopening of the circuit with connection of the one-way valve).
Failure may occur earlier than Day 6: on Day 0 (Hour 0, Hour 4 or Hour 8) or Day 2 in the manual aspiration arm, and on Day 4 in the one-way valve arm.
A patient switched from manual aspiration to the one-way valve is a failure even if the lung is re-expanded on Day 6.
Pneumothorax thresholds are defined in the Detailed Description and Eligibility part.
Measured: Day 6
Secondary outcomes (4)
Comparison of pain intensity between the two arms
Pain intensity assessed on a Visual Analogue Scale (VAS) for pain intensity ranging from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate worse pain, at catheter insertion [Day 0], after each aspiration procedure (manual aspiration arm) [Day 0], at catheter removal, and daily from Day 1 to Day 6. Pain is compared between the manual aspiration arm and the one-way valve arm.
Measured: Day 0 to Day 6
Comparison of analgesic consumption between the two arms
Analgesic use at catheter insertion and daily from Day 1 to Day 6, recorded by WHO analgesic ladder step (step 1, 2 or 3). Consumption is compared between the manual aspiration arm and the one-way valve arm.
Measured: Day 0 to Day 6
Comparison of the cost of management between the two arms
Cost of each management strategy, including the estimated cost of hospitalization in case of early failure of manual aspiration. Costs are compared between the manual aspiration arm and the one-way valve arm.
Measured: Day 6
Comparison of pneumothorax recurrence between the two arms
Recurrence of pneumothorax assessed by telephone call or email at Months 3, 6, 9 and 12. Recurrence rates are compared between the manual aspiration arm and the one-way valve arm.
Measured: Months 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start17 Sep 2021
- Primary completion24 Sep 2026
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax Spontaneous PrimaryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Model description
- Prospective, open-label, multicenter, randomized, double-arm, parallel-group superiority trial study
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691480
- Sponsor's protocol ID
- 35RC17_8995_PNEUM-AMBU
- Other IDs
- 2019-A00085-52
- Acronym
- PNEUM-AMBU
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2018
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03691480
- Acronym / sponsor ID
- PNEUM-AMBU / 35RC17_8995_PNEUM-AMBU
- Conditions
- Pneumothorax Spontaneous Primary
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 1 Oct 2018 (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 management of large spontaneous pneumothorax is not consensual. Current practice involves placement of a Fuhrman catheter connected to a one-way valve, with outpatient monitoring in pneumology consultation. Manual aspiration is a widely used alternative, but the two approaches have never been directly compared in a prospective study.
The main objective of this randomized trial is to compare the efficacy of these two ambulatory strategies in adults with an episode of large unilateral primary spontaneous pneumothorax. We hypothesize that management with a Fuhrman catheter and one-way valve is superior to manual aspiration.
Detailed description
This is a multicenter, randomized, open-label, parallel-group superiority trial. Eligible patients are adults (between 18 years old and 50 years old) presenting to the emergency department of a participating center with a large unilateral primary spontaneous pneumothorax. After information and written consent, patients are randomized on Day 0 to one of two arms :
- ambulatory management with pigtail catheter connected to one-way valve as previously published (Voisin F et al. Ann Emerg Med 2014; Sale A et al. Respir Med 2020) or
- manual aspiration as described in international guidelines.
Large pneumothorax is defined according to BTS, ACCP and/or French guidelines as a separation of ≥ 2 cm at the hilum, and/or ≥ 3 cm at the apex, and/or ≥ 2 cm over the whole height on an axillary view. Complete or near-complete re-expansion means a residual pneumothorax below these thresholds; otherwise the pneumothorax is considered persistent.
In both arms, failure is defined as hospitalization. In the manual aspiration arm, it also includes switching to the one-way valve arm (circuit reopened, valve connected), which is immediate (Day 0, Hour 0) if an aspirated volume of ≥ 2 L (40 syringes) is reached. The patient then receives usual care.
- Other data collected. All patients are seen on Day 2, Day 6 and, if needed, Day 4, with a standard pulmonology history and clinical examination. Pain and analgesic consumption are recorded daily from Day 1 to Day 6, together with adverse events. Pain is also assessed at catheter removal.
- Long-term follow-up. Patients are contacted at Months 3, 6, 9 and 12 to document pneumothorax recurrence and pleurodesis.
- Previous inclusion / Repeat episodes Patients already included in this study for a previous large PSP episode are not eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-label, multicenter, randomized, double-arm, parallel-group superiority trial study
| Arm | Type | Receives |
|---|---|---|
| One-way valve | Active comparator | Procedure: Fuhrman catheter insertion, Procedure: Three-way stopcock openAmbulatory management with the Fuhrman catheter connected to a one-way valve, with chest X-ray follow-up on Day 0, Day 2, Day 4 if needed, and Day 6. |
| Manual aspiration | Experimental | Procedure: Fuhrman catheter insertion, Procedure: Manual aspirationManual aspiration with 50 mL syringes through the Fuhrman catheter on Day 0 (optional second aspiration), followed by closure of the three-way stopcock, with chest X-rays at Hour 4, Hour 8 (if applicable), Day 2 and Day 6. An aspirated volume ≥ 2 L (40 syringes), a persistent large pneumothorax after the last aspiration or on Day 2 leads to reopening of the circuit and connection of the one-way valve (failure). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (5 listed)
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 |
|---|---|---|
| Fuhrman catheter insertion8.5 French Fuhrman catheter insertion using the Seldinger technique, connected to a three-way stopcock and a one-way valve | Procedure or surgery | Manual aspiration, One-way valve |
| Three-way stopcock openOpening of the three-way stopcock on Day 0 to connect the Fuhrman catheter to the one-way valve | Procedure or surgery | One-way valve |
| Manual aspirationManual aspiration through the Fuhrman catheter with a 50 mL syringe through the Fuhrman catheter on Day 0, followed by closure of the three-way stopcock (optional second aspiration). | Procedure or surgery | Manual aspiration |
Primary outcome
Rate of successful ambulatory management
Time frame: Day 6
Success is assessed for each patient at Day 6 and is defined as complete or near-complete lung re-expansion on the Day 6 chest X-ray, without hospitalization decided by the treating physician and, in the manual aspiration arm, without change of arm (reopening of the circuit with connection of the one-way valve). Failure may occur earlier than Day 6: on Day 0 (Hour 0, Hour 4 or Hour 8) or Day 2 in the manual aspiration arm, and on Day 4 in the one-way valve arm. A patient switched from manual aspiration to the one-way valve is a failure even if the lung is re-expanded on Day 6. Pneumothorax thresholds are defined in the Detailed Description and Eligibility part.
4 secondary outcomes
Comparison of pain intensity between the two arms
Time frame: Day 0 to Day 6
Comparison of analgesic consumption between the two arms
Time frame: Day 0 to Day 6
Comparison of the cost of management between the two arms
Time frame: Day 6
Comparison of pneumothorax recurrence between the two arms
Time frame: Months 3, 6, 9 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fuhrman catheter insertion, Three-way stopcock open and Manual aspiration in people with Pneumothorax Spontaneous Primary, run by Rennes University Hospital at 5 sites 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of successful ambulatory management (time frame: Day 6). 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 22 Oct 2026.