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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04548479
Enrollment
90
Registered
2020-09-14
Start date
2020-03-03
Completion date
2022-09-01
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma Chest

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Hospital de Granollers
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Los evaluadores de los resultados y el investigador que realiza la aleatorización

Intervention model description

aleatorizado 1:1

Eligibility

Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improve the degree of pain1 monthTo assess if PEP decreased pain

Secondary

MeasureTime frameDescription
Resolution of pleural lesions1 monthTo analysed if PEP allows faster resolution of pleural lesions
Improve lung function1 monthTo determined if PEP improves functional sequelae secondary to thoracic trauma.
Reduce hospital stay1 monthTo assess if PEP decreased hospital stay

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026