Impact of Forced Expiration On Pleural Drainage Duration (KPDP)

Child Clinical Trial

— KPDP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02660203
• Other study ID #: PHRIP-14/EC/KPDP
• Secondary ID: 2015-A01549-40
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2020

Study information

• Verified date: October 2018
• Source: University Hospital, Tours
• Contact: Emilie CHICOISNE, Mrs
• Phone: (33) 2 47 47 47 47
• Email: e.chicoisne[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Child
• Congenital Abnormalities
• Pulmonary Malformations

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Uh Angers	Angers
France	UH BREST	Brest
France	Hospices civiles Lyon	Bron
France	UH of PARIS - KREMLIN BICETRE Hospital	Le Kremlin-Bicêtre
France	Uh Limoges	Limoges
France	UH Marseille	Marseille
France	Uh Nantes	Nantes
France	UH of PARIS - NECKER Hospital	Paris
France	UH of PARIS - Robert Debre Hospital	Paris
France	UH Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of pleural drainage duration	During the post-operative period until chest tube removal amount of pleural liquid drained is daily assessed.	3 days
Secondary	assessment of total amount of pleural liquid drained	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	3 days
Secondary	Assessment of pain	Pain scale score (EVENDOL 0 to 15)	3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48
Secondary	patient's respiratory parameters	level of oxygen dependency (L/min) during the post-operative period until chest tube removal	3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
Secondary	paramedical workload	Paramedical workload assessed by the time consumption (Hours) due to drainage tube	3 days
Secondary	Oxygen blood saturation	Oxygen blood saturation (%) during the post-operative period until chest tube removal	3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48