Impact of Forced Expiration On Pleural Drainage Duration (KPDP)

R

Regional University Hospital Center (CHRU)

Status

Unknown

Conditions

Pulmonary Malformations
Child

Treatments

Procedure: Forced expiration

Study type

Interventional

Funder types

Other

Identifiers

NCT02660203
PHRIP-14/EC/KPDP
2015-A01549-40 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

140 estimated patients

Sex

All

Ages

1 day to 48 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

forced expiration
Experimental group
Description:
2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal
Treatment:
Procedure: Forced expiration
control
No Intervention group
Description:
No session of forced expiration

Trial contacts and locations

10

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Central trial contact

Emilie CHICOISNE, Mrs; Hubert LARDY, MD

Data sourced from clinicaltrials.gov

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