Clinical trial NCT02660203: Impact of Forced Expiration On Pleural Drainage Duration (KPDP)
Official title: Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Malformations
Child
Keywords: chest physiotherapy
post operative period
forced expiration
pleural drainage duration
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* chest trauma
* Oncology (chest tumors, lung metastases)
* Drained Pleuropneumopathies
* Spine Surgery
* Heart surgery
* Surgery for pectus excavatum
* Route of anterior surgical approach sternotomy chest kind
* Patients intubated and / or ventilated
* Patients with preoperative sepsis

Primary outcomes:
measure: assessment of pleural drainage duration
timeFrame: 3 days
Secondary outcomes:
measure: assessment of total amount of pleural liquid drained
timeFrame: 3 days
measure: Assessment of pain
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48
measure: patient's respiratory parameters
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
measure: paramedical workload
timeFrame: 3 days
measure: Oxygen blood saturation
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
Other outcomes:
Locations:
city: Angers
country: France
facility: Uh Angers
city: Brest
country: France
facility: UH BREST
city: Bron
country: France
facility: Hospices civiles Lyon
city: Le Kremlin-Bicêtre
country: France
facility: UH of PARIS - KREMLIN BICETRE Hospital
city: Limoges
country: France
facility: Uh Limoges
city: Marseille
country: France
facility: UH Marseille
city: Nantes
country: France
facility: Uh Nantes
city: Paris
country: France
facility: UH of PARIS - NECKER Hospital
city: Paris
country: France
facility: UH of PARIS - Robert Debre Hospital
city: Tours
country: France
facility: UH Tours
Study officials:
affiliation: UH TOURS
name: Emilie CHICOISNE, Mrs
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Tours
name: Hubert LARDY, MD
role: PRINCIPAL_INVESTIGATOR
References: