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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Trauma Chest

Intervention / Treatment
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* Device: PEP bottle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: aleatorizado 1:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEP group<br>Chest physiotherapy depending on the location of the ribs fractures techniques are performed: 1. Postural control techniques; 2. Airways clearance techniques; 3. Breathing exercise (diaphragmatic breathing). 4. Early mobilization. 5. Positive expiratory pressure (PEP) breathing | Device: PEP bottle<br>* 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.<br>|
| No Intervention: INS group<br>Chest physiotherapy depending on the location of the ribs fractures techniques are performed: 1. Postural control techniques; 2. Airways clearance techniques; 3. Breathing exercise (diaphragmatic breathing). 4. Early mobilization. 5. Inspiratory incentive spirometry breathing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve the degree of pain | To assess if PEP decreased pain | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of pleural lesions | To analysed if PEP allows faster resolution of pleural lesions | 1 month | 
| Improve lung function | To determined if PEP improves functional sequelae secondary to thoracic trauma. | 1 month | 
| Reduce hospital stay | To assess if PEP decreased hospital stay | 1 month |