Pulmonary MalformationsKPDPNCT02660203
Impact of Forced Expiration On Pleural Drainage Duration (KPDP)
A study testing Forced expiration in people with Pulmonary Malformations and Child, run by University Hospital, Tours at 10 sites in France.
Trial summary
Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage. Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. Read more about this study
- Who is it for?
- Ages 1 day to 48 weeks
- Conditions the study is for
- Pulmonary Malformations, Child
- What is being tested?
- Forced expiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 10 sitesFrance
- Study dates
- May 2016to May 2020
- 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 1 day to 48 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 0-4 years
- In front have a mediastinum or lung surgery (lung segmentectomy or lobectomy or non anatomical lung resection) with pleural drainage, regardless of the type drain
- Whose parents or the holder of parental authority have signed a consent
- Whose parents or the holder of parental authority are affiliated to a social security scheme
Who cannot join
- chest trauma
- Oncology (chest tumors, lung metastases)
- Drained Pleuropneumopathies
- Spine Surgery
- Heart surgery
- Surgery for pectus excavatum
Show all 9Show fewer
- Route of anterior surgical approach sternotomy chest kind
- Patients intubated and / or ventilated
- Patients with preoperative sepsis
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Uh Angers
Angers, 49033
UH BREST
Brest, 29200
Hospices civiles Lyon
Bron, 69677
UH of PARIS - KREMLIN BICETRE Hospital
Le Kremlin-Bicêtre, 94140
Uh Limoges
Limoges, 87000
UH Marseille
Marseille, 13385
Uh Nantes
Nantes, 44093
UH of PARIS - NECKER Hospital
Paris, 75.015
UH of PARIS - Robert Debre Hospital
Paris, 75019
UH Tours
Tours
About this study
Official title: Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial
Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage.
Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These complications could be avoided by respiratory physiotherapy.
Forced expiration technic in ipsilateral decubitus is one of these technics but has never been proved better than other technics regarding its efficiency.
The aim of the study is to compare the impact of such a technic on post operative thoracic drainage after pulmonary, pleural or mediastinal pediatric surgery.
Read the detailed description
Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage, most often for few days (2 to 5 days) until fluid quantity is lower than 50 mL / 24h.
Pleural effusion may cause pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude.
Respiratory physiotherapy in such situations has different aims : pulmonary decongestion and reexpansion, aid for drainage and pleural fluid reduction, avoiding complications and preventing vicious attitudes.
These aims are learned in Physiotherapy formation institutes. The forced expiration technic in ipsilateral decubitus is justified by pleural physiology and is used after pediatric surgery without any scientific evidence regarding his efficacy Using pulmonary physiotherapy after pulmonary, mediastinal or pleural surgery for children is not systematic and depends on prescriber without any professional recommendation.
Actually no scientific evidence regarding technical or postural indicates improvement of effusion drainage.
It seems to be necessary to validate efficiency of such a technic and evaluate its consequences on post-operative pain. Furthermore, this pleural drainage impacts directly the duration of hospitalization and paramedical workload
- Conditions
- Pulmonary Malformations, Child
- Being tested
- Forced expiration
- Keywords
- chest physiotherapy, post operative period, forced expiration, pleural drainage duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced expirationProcedure or surgery
Amongst chest physiotherapy technics, forced expiration is one of the passive procedures used in pediatrics.
The patient is positioned on ipsilateral decubitus and the physiotherapist is behind the patient, placing one hand on the patient abdomen and the other on the patient lateral chest. During expiration, the abdominal hand apply a pressure directed posteriorly and superiorly for the patient. Simultaneously, the thoracic hand apply a pressure posteriorly and inferiorly for the patient. The session's duration is 15 minutes after what the physiotherapist replace the patient in dorsal decubitus.Two sessions a day will be performed
| Study group | Role | What they receive |
|---|---|---|
| forced expiration | Experimental | 2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal Receives: Procedure: Forced expiration |
| control | No intervention | No session of forced expiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of pleural drainage duration
During the post-operative period until chest tube removal amount of pleural liquid drained is daily assessed.
Measured: 3 days
Secondary outcomes (5)
assessment of total amount of pleural liquid drained
Calculating cumulative volume of liquid provided by the drain (until it reaches 50 cc or less during the last day) during the post-operative period until chest tube removal
Measured: 3 days
Assessment of pain
Pain scale score (EVENDOL 0 to 15)
Measured: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48
patient's respiratory parameters
level of oxygen dependency (L/min) during the post-operative period until chest tube removal
Measured: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
paramedical workload
Paramedical workload assessed by the time consumption (Hours) due to drainage tube
Measured: 3 days
Oxygen blood saturation
Oxygen blood saturation (%) during the post-operative period until chest tube removal
Measured: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary MalformationsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie CHICOISNE, Mrs, Principal investigator, UH TOURSHubert LARDY, MD, Principal investigator, UH Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660203
- Sponsor's protocol ID
- PHRIP-14/EC/KPDP
- Other IDs
- 2015-A01549-40
- Acronym
- KPDP
- Status last verified
- Jun 2026
- First submitted
- 5 Jan 2016
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial
- ClinicalTrials.gov ID
- NCT02660203
- Acronym / sponsor ID
- KPDP / PHRIP-14/EC/KPDP
- Conditions
- Pulmonary Malformations, Child
- Keywords
- chest physiotherapy, post operative period, forced expiration, pleural drainage duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 21 Jan 2016 (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.
Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage.
Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These complications could be avoided by respiratory physiotherapy.
Forced expiration technic in ipsilateral decubitus is one of these technics but has never been proved better than other technics regarding its efficiency.
The aim of the study is to compare the impact of such a technic on post operative thoracic drainage after pulmonary, pleural or mediastinal pediatric surgery.
Detailed description
Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage, most often for few days (2 to 5 days) until fluid quantity is lower than 50 mL / 24h.
Pleural effusion may cause pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude.
Respiratory physiotherapy in such situations has different aims : pulmonary decongestion and reexpansion, aid for drainage and pleural fluid reduction, avoiding complications and preventing vicious attitudes.
These aims are learned in Physiotherapy formation institutes. The forced expiration technic in ipsilateral decubitus is justified by pleural physiology and is used after pediatric surgery without any scientific evidence regarding his efficacy Using pulmonary physiotherapy after pulmonary, mediastinal or pleural surgery for children is not systematic and depends on prescriber without any professional recommendation.
Actually no scientific evidence regarding technical or postural indicates improvement of effusion drainage.
It seems to be necessary to validate efficiency of such a technic and evaluate its consequences on post-operative pain. Furthermore, this pleural drainage impacts directly the duration of hospitalization and paramedical workload
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| forced expiration | Experimental | Procedure: Forced expiration2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal |
| control | No intervention | –No session of forced expiration |
Who may qualify
- Ages
- 1 day to 48 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 0-4 years
- In front have a mediastinum or lung surgery (lung segmentectomy or lobectomy or non anatomical lung resection) with pleural drainage, regardless of the type drain
- Whose parents or the holder of parental authority have signed a consent
- Whose parents or the holder of parental authority are affiliated to a social security scheme
Key exclusion criteria (9 listed)
- chest trauma
- Oncology (chest tumors, lung metastases)
- Drained Pleuropneumopathies
- Spine Surgery
- Heart surgery
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 |
|---|---|---|
| Forced expirationAmongst chest physiotherapy technics, forced expiration is one of the passive procedures used in pediatrics. The patient is positioned on ipsilateral decubitus and the physiotherapist is behind the patient, placing one hand on the patient abdomen and the other on the patient lateral chest. During expiration, the abdominal hand apply a pressure directed posteriorly and superiorly for the patient. Simultaneously, the thoracic hand apply a pressure posteriorly and inferiorly for the patient. The session's duration is 15 minutes after what the physiotherapist replace the patient in dorsal decubitus.Two sessions a day will be performed | Procedure or surgery | forced expiration |
Primary outcome
assessment of pleural drainage duration
Time frame: 3 days
During the post-operative period until chest tube removal amount of pleural liquid drained is daily assessed.
5 secondary outcomes
assessment of total amount of pleural liquid drained
Time frame: 3 days
Assessment of pain
Time frame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48
patient's respiratory parameters
Time frame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
paramedical workload
Time frame: 3 days
Oxygen blood saturation
Time frame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
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 15 Jun 2026.
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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.
Emilie CHICOISNE, Mrs principal investigator
UH TOURS
Hubert LARDY, MD principal investigator
UH Tours
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced expiration in people with Pulmonary Malformations and Child, run by University Hospital, Tours at 10 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 4 inclusion and 9 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
assessment of pleural drainage duration (time frame: 3 days). 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 15 Jun 2026.