Skip to main content
OpenTrials
Completed

NCT Number: NCT04548466

Effect of Positive Expiratory Pressure on the Management of Chest Trauma

Chest trauma (CT) are a common problem in our environment caused mainly by traffic accidents and causal and domestic accidents among the elderly population. CTs, in some situations, can lead to sequelae such as fibrothorax secondary to hemothorax and / or empyema and residual chronic pain. Clinical regulations and guidelines recommend a guideline for chest physiotherapy (CP) for all patients with rib fractures, but there is little scientific evidence. It would be interesting to establish CP treatment protocols and describe the most appropriate techniques according to the type and stages of thoracic trauma consolidation.

Objective: To evaluate the effect of Positive Expiratory Pressure (PEP) breathing added to conventional CP in terms of aid secretion clearance, pain control, pleuropulmonary radiological abnormalities, restoration of lung function, and admission days in the immediate phase of the CT.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inmaculada Castillo

Seva, Barcelona, 08553, Spain

About this study

After acceptance to participate in the study, patients will be computerized randomized into 2 groups:

  • PEP group: positive expiratory pressure breathing.
  • CONTROL group: conventional CP treatment without positive pressure brething. The period between day 0 and 20 days post-trauma is considered an immediate phase of CT.

Once admitted, an initial evaluation by the doctor will be performed, and pleuro-pulmonary complications, the presence of respiratory failure, and pain control will be evaluated. The chest physiotherapist will perform a clinical and secretion assessment using the Seva test and a dynamic costal examination. The medical treatment of pain control will begin, and the treatment of CP will begin, where it will be randomized in 2 groups: 1- PEP group: positive expiratory pressure breathing with the help of a PEP bottle device. 2-CONTROL group: conventional CP treatment without positive pressure breathing will be daily FR sessions, on weekdays. Upon admission, hospital discharge and post-discharge, radiological checks (simple radiography) will be performed and forced vital capacity will be measured with forced spirometry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chest trauma with three or more rib fractures with or without hemopneumothorax
  • Failure to meet any exclusion criteria

Exclusion criteria

  • Non-cooperative patients for not understanding chest physiotherapy techniques.
  • Presence of respiratory failure on admission: PaO2 <60mmHg i / or PaCO2> 50mmHg.
  • Medical indication for mechanical ventilation or non-invasive ventilatory support.
  • Presence of undrained pneumothorax.
  • Complications that limit early mobility.

Treatment and study plan

PEP bottle

Device

Primary outcomes

  1. Aid secretion clearance

    Time frame: 1 month

    To determine if PEP bottle improves the secretion clearance

Secondary outcomes

  1. Resolution of pleural lesions

    Time frame: 1 month

    To analysed if PEP bottle allows faster resolution of pleural lesions

  2. Improve lung function

    Time frame: 1 month

    To determine if PEP bottle improves lung function tests

  3. Reduce hospital stay

    Time frame: 1 month

    To assess if PEP bottle decreased hospital stay

Sponsors and collaborators

Lead sponsor

Hospital de Granollers

Other

Registry information

Official study title

Effect of Positive Expiratory Pressure on the Management of Chest Trauma: a Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.