Impact of Forced Expiration On Pleural Drainage Duration (KPDP)
- Conditions
- Pulmonary MalformationsChild
- Interventions
- Procedure: Forced expiration
- Registration Number
- NCT02660203
- Lead Sponsor
- University Hospital, Tours
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description forced expiration Forced expiration 2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal
- Primary Outcome Measures
Name Time Method assessment of pleural drainage duration 3 days During the post-operative period until chest tube removal amount of pleural liquid drained is daily assessed.
- Secondary Outcome Measures
Name Time Method assessment of total amount of pleural liquid drained 3 days 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
Assessment of pain 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48 Pain scale score (EVENDOL 0 to 15)
patient's respiratory parameters 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 level of oxygen dependency (L/min) during the post-operative period until chest tube removal
paramedical workload 3 days Paramedical workload assessed by the time consumption (Hours) due to drainage tube
Oxygen blood saturation 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Oxygen blood saturation (%) during the post-operative period until chest tube removal
Trial Locations
- Locations (10)
UH BREST
🇫🇷Brest, France
Uh Angers
🇫🇷Angers, France
Hospices civiles Lyon
🇫🇷Bron, France
Uh Limoges
🇫🇷Limoges, France
UH Marseille
🇫🇷Marseille, France
UH of PARIS - NECKER Hospital
🇫🇷Paris, France
UH of PARIS - Robert Debre Hospital
🇫🇷Paris, France
UH Tours
🇫🇷Tours, France
UH of PARIS - KREMLIN BICETRE Hospital
🇫🇷Le Kremlin-Bicêtre, France
Uh Nantes
🇫🇷Nantes, France