NCT02660203

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 15, 2018

Status Verified

October 1, 2018

Enrollment Period

4 years

First QC Date

January 5, 2016

Last Update Submit

November 14, 2018

Conditions

Pulmonary MalformationsChild

Keywords

chest physiotherapypost operative periodforced expirationpleural drainage duration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • assessment of total amount of pleural liquid drained

    3 days

  • Assessment of pain

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

  • patient's respiratory parameters

    3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48

  • paramedical workload

    3 days

  • Oxygen blood saturation

    3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48

Study Arms (2)

forced expiration

EXPERIMENTAL

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

Procedure: Forced expiration

control

NO INTERVENTION

No session of forced expiration

Interventions

Forced expirationPROCEDURE

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

forced expiration

Eligibility Criteria

Age1 Day - 48 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Uh Angers

Angers, 49033, France

RECRUITING

UH BREST

Brest, 29200, France

RECRUITING

Hospices civiles Lyon

Bron, 69677, France

RECRUITING

UH of PARIS - KREMLIN BICETRE Hospital

Le Kremlin-Bicêtre, 94140, France

ACTIVE NOT RECRUITING

Uh Limoges

Limoges, 87000, France

RECRUITING

UH Marseille

Marseille, 13385, France

RECRUITING

Uh Nantes

Nantes, 44093, France

RECRUITING

UH of PARIS - NECKER Hospital

Paris, 75.015, France

RECRUITING

UH of PARIS - Robert Debre Hospital

Paris, 75019, France

ACTIVE NOT RECRUITING

UH Tours

Tours, France

RECRUITING

Study Officials

  • Emilie CHICOISNE, Mrs

    UH TOURS

    PRINCIPAL INVESTIGATOR

  • Hubert LARDY, MD

    UH Tours

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie CHICOISNE, Mrs

CONTACT

(33) 2 47 47 47 47e.chicoisne@chu-tours.fr

Hubert LARDY, MD

CONTACT

(33) 2 47 47 47 47hubert.lardy@univ-tours.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 21, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

November 15, 2018

Record last verified: 2018-10

Locations

FR(10)