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

November 14, 2018 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: forced expiration
2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal
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
No Intervention: control
No session of forced expiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days
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, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48
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
3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48
paramedical workload
Time Frame: 3 days
Paramedical workload assessed by the time consumption (Hours) due to drainage tube
3 days
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
3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Emilie CHICOISNE, Mrs, UH Tours
  • Principal Investigator: Hubert LARDY, MD, UH Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 18, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRIP-14/EC/KPDP
  • 2015-A01549-40 (Registry Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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