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Completed

NCT Number: NCT04548479

A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma

Chest trauma (CT) patients with 3 or more ribs fractures with or without pleuropulmonary injury are an indicator of severity. Chest physiotherapy (CP) and analgesia is the first line treatment in these patients.

The aim study is to evaluate the effect of positive expiratory pressure (PEP) breathing compared to the incentive spirometry in terms of pain control in the recent phase of CT.

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Key information

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 (PEP) breathing.
  • INS group: inspiratory incentive spirometry breathing. The period between day 0 and 20 days post-trauma is considered an immediate phase of TT.

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 CP will perform a clinical, pain control, secretion 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 (PEP) breathing the help of a PEP bottle device. 2- INS group: inspiratory incentive spirometry device (Coach®). 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 of 3 or more rib fractures with or without hemopneumothorax
  • Signed informed consent.

Exclusion criteria

  • Non-collaborating patients.
  • Failure to submit a duly completed follow-up sheet for carrying out a minimum daily guideline (3 times a day) for CP treatment.
  • Presence of respiratory failure at admission: PaO2 <60mmHg and / or PaCO2> 50mmHg.
  • Medical indication for invasive or non-invasive ventilatory support.
  • Presence of undrained pneumothorax.
  • Complications that limit early mobility.

Treatment and study plan

PEP bottle

Device

PEP bottle: it will be performed with a bottle of distilled water and a plastic tube, where the patient breathes against a resistance during expiration.

Primary outcomes

  1. Improve the degree of pain

    Time frame: 1 month

    To assess if PEP decreased pain

Secondary outcomes

  1. Resolution of pleural lesions

    Time frame: 1 month

    To analysed if PEP allows faster resolution of pleural lesions

  2. Improve lung function

    Time frame: 1 month

    To determined if PEP improves functional sequelae secondary to thoracic trauma.

  3. Reduce hospital stay

    Time frame: 1 month

    To assess if PEP decreased hospital stay

Sponsors and collaborators

Lead sponsor

Hospital de Granollers

Other

Registry information

Official study title

A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Patients With Chest Trauma: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2020
Registry last updated
Apr 14, 2023

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.

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