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NCT Number: NCT02660203

Impact of Forced Expiration On Pleural Drainage Duration (KPDP)

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.

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Key information

Conditions

Pulmonary Malformations Child

Age range

1 day–48 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uh Angers, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forced expiration

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. assessment of total amount of pleural liquid drained

    Time frame: 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

  2. Assessment of pain

    Time frame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48

    Pain scale score (EVENDOL 0 to 15)

  3. patient's respiratory parameters

    Time frame: 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

  4. paramedical workload

    Time frame: 3 days

    Paramedical workload assessed by the time consumption (Hours) due to drainage tube

  5. Oxygen blood saturation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial

Acronym: KPDP

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2016
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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