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

Hospital de Granollers

Status: Completed

Conditions: Trauma Chest

Treatments: Device: PEP bottle

Study type: Interventional

Funder types: Other

Identifiers

NCT04548479

Incentive Spirometry vs PEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

PEP group

Active Comparator group

Description:

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

Treatment:

Device: PEP bottle

INS group

No Intervention group

Description:

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