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Impact of Forced Expiration On Pleural Drainage Duration (KPDP) (KPDP)

Primary Purpose

Pulmonary Malformations, Child

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Forced expiration
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Malformations focused on measuring chest physiotherapy, post operative period, forced expiration, pleural drainage duration

Eligibility Criteria

1 Day - 48 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • Uh AngersRecruiting
  • UH BRESTRecruiting
  • Hospices civiles LyonRecruiting
  • UH of PARIS - KREMLIN BICETRE Hospital
  • Uh LimogesRecruiting
  • UH MarseilleRecruiting
  • Uh NantesRecruiting
  • UH of PARIS - NECKER HospitalRecruiting
  • UH of PARIS - Robert Debre Hospital
  • UH ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

forced expiration

control

Arm Description

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

No session of forced expiration

Outcomes

Primary Outcome Measures

assessment of pleural drainage duration
During the post-operative period until chest tube removal amount of pleural liquid drained is daily assessed.

Secondary Outcome Measures

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
Assessment of pain
Pain scale score (EVENDOL 0 to 15)
patient's respiratory parameters
level of oxygen dependency (L/min) during the post-operative period until chest tube removal
paramedical workload
Paramedical workload assessed by the time consumption (Hours) due to drainage tube
Oxygen blood saturation
Oxygen blood saturation (%) during the post-operative period until chest tube removal

Full Information

First Posted
January 5, 2016
Last Updated
November 14, 2018
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02660203
Brief Title
Impact of Forced Expiration On Pleural Drainage Duration (KPDP)
Acronym
KPDP
Official Title
Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Malformations, Child
Keywords
chest physiotherapy, post operative period, forced expiration, pleural drainage duration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
forced expiration
Arm Type
Experimental
Arm Description
2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal
Arm Title
control
Arm Type
No Intervention
Arm Description
No session of forced expiration
Intervention Type
Procedure
Intervention Name(s)
Forced expiration
Intervention Description
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 Outcome Measure Information:
Title
assessment of pleural drainage duration
Description
During the post-operative period until chest tube removal amount of pleural liquid drained is daily assessed.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
assessment of total amount of pleural liquid drained
Description
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
Time Frame
3 days
Title
Assessment of pain
Description
Pain scale score (EVENDOL 0 to 15)
Time Frame
3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48
Title
patient's respiratory parameters
Description
level of oxygen dependency (L/min) during the post-operative period until chest tube removal
Time Frame
3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
Title
paramedical workload
Description
Paramedical workload assessed by the time consumption (Hours) due to drainage tube
Time Frame
3 days
Title
Oxygen blood saturation
Description
Oxygen blood saturation (%) during the post-operative period until chest tube removal
Time Frame
3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
48 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie CHICOISNE, Mrs
Phone
(33) 2 47 47 47 47
Ext
7. 29 52
Email
e.chicoisne@chu-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hubert LARDY, MD
Phone
(33) 2 47 47 47 47
Ext
7. 14 95
Email
hubert.lardy@univ-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie CHICOISNE, Mrs
Organizational Affiliation
UH TOURS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hubert LARDY, MD
Organizational Affiliation
UH Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uh Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane COUTURIER, Mr
Phone
(33) 6 65 80 72 56
Email
stcouturier@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Guillaume PODEVIN, MD
Phone
(33) 2 41 35 42 95
Email
GuPodevin@chu-angers.fr
Facility Name
UH BREST
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine RAOUL, Mrs
Email
catherine.raoul@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Philine DE VRIES, MD
Email
philine.devries@chu-brest.fr
Facility Name
Hospices civiles Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MULIER Catherine, Mrs
Phone
(33) 27855268
Email
catherine.mulier@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
HAMEURY Frédéric, MD
Phone
(33) 427855938
Email
frederic.hameury@chu-lyon.fr
Facility Name
UH of PARIS - KREMLIN BICETRE Hospital
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94140
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Uh Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique PEJOAN, Mr
Email
Dominique.Pejoan@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Laurent FOURCADE, MD
Email
Laurent.Fourcade@chu-limoges.fr
Facility Name
UH Marseille
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TOURNIE Brigitte, Mrs
Phone
(33) 623208504
Email
Brigitte.TOURNIE@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
BOUBNOVA Julia, MD
Phone
(33) 668723092
Email
Julia.BOUBNOVA@ap-hm.fr
Facility Name
Uh Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid CROSS, Mrs
Phone
(33) 6 63 55 95 97
Email
ingris.cross@gmail.com
First Name & Middle Initial & Last Name & Degree
Stephan DE NAPOLI COCCI, MD
Phone
(33) 2 40 08 33 33
Ext
83 663
Email
Stephan.DENAPOLICOCCI@chu-nantes.fr
Facility Name
UH of PARIS - NECKER Hospital
City
Paris
ZIP/Postal Code
75.015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles GRIMARD, Mr
Email
charles.grimard@nck.aphp.fr
First Name & Middle Initial & Last Name & Degree
Naziha KHEN DUNLOP, MD
Phone
06 19 02 38 14
Email
naziha.khen-dunlop@nck.aphp.fr
Facility Name
UH of PARIS - Robert Debre Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Active, not recruiting
Facility Name
UH Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie CHICOISNE, Mrs
Phone
(33) 2 47 47 47 47
Ext
7 29 52
Email
e.chicoisne@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Michele Carriot, Mrs
Phone
(33) 2 18 37 06 01
Email
m.carriot@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
LARDY Hubert, MPh

12. IPD Sharing Statement

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Impact of Forced Expiration On Pleural Drainage Duration (KPDP)

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