Impact of Forced Expiration On Pleural Drainage Duration (KPDP)

NCT ID: NCT02660203

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-05-31

Brief Summary

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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

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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

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Pulmonary Malformations Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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forced expiration

2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal

Group Type EXPERIMENTAL

Forced expiration

Intervention Type 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

control

No session of forced expiration

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Forced expiration

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

48 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie CHICOISNE, Mrs

Role: PRINCIPAL_INVESTIGATOR

UH TOURS

Hubert LARDY, MD

Role: PRINCIPAL_INVESTIGATOR

UH Tours

Locations

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Uh Angers

Angers, , France

Site Status RECRUITING

UH BREST

Brest, , France

Site Status RECRUITING

Hospices civiles Lyon

Bron, , France

Site Status RECRUITING

UH of PARIS - KREMLIN BICETRE Hospital

Le Kremlin-Bicêtre, , France

Site Status ACTIVE_NOT_RECRUITING

Uh Limoges

Limoges, , France

Site Status RECRUITING

UH Marseille

Marseille, , France

Site Status RECRUITING

Uh Nantes

Nantes, , France

Site Status RECRUITING

UH of PARIS - NECKER Hospital

Paris, , France

Site Status RECRUITING

UH of PARIS - Robert Debre Hospital

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

UH Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emilie CHICOISNE, Mrs

Role: CONTACT

(33) 2 47 47 47 47 ext. 7. 29 52

Hubert LARDY, MD

Role: CONTACT

(33) 2 47 47 47 47 ext. 7. 14 95

Facility Contacts

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Stephane COUTURIER, Mr

Role: primary

(33) 6 65 80 72 56

Guillaume PODEVIN, MD

Role: backup

(33) 2 41 35 42 95

Catherine RAOUL, Mrs

Role: primary

Philine DE VRIES, MD

Role: backup

MULIER Catherine, Mrs

Role: primary

(33) 27855268

HAMEURY Frédéric, MD

Role: backup

(33) 427855938

Dominique PEJOAN, Mr

Role: primary

Laurent FOURCADE, MD

Role: backup

TOURNIE Brigitte, Mrs

Role: primary

(33) 623208504

BOUBNOVA Julia, MD

Role: backup

(33) 668723092

Ingrid CROSS, Mrs

Role: primary

(33) 6 63 55 95 97

Stephan DE NAPOLI COCCI, MD

Role: backup

(33) 2 40 08 33 33 ext. 83 663

Charles GRIMARD, Mr

Role: primary

Naziha KHEN DUNLOP, MD

Role: backup

06 19 02 38 14

Emilie CHICOISNE, Mrs

Role: primary

(33) 2 47 47 47 47 ext. 7 29 52

Michele Carriot, Mrs

Role: backup

(33) 2 18 37 06 01

Other Identifiers

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2015-A01549-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

PHRIP-14/EC/KPDP

Identifier Type: -

Identifier Source: org_study_id

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