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

Not Applicable

Completed

• Conditions: Trauma Chest
• Interventions: Device: PEP bottle

• Registration Number: NCT04548479
• Lead Sponsor: Hospital de Granollers

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.

Study Timeline

• Study Start: 2020-03-03
• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-14
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP group	PEP bottle	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

Primary Outcome Measures

Name	Time	Method
Improve the degree of pain	1 month	To assess if PEP decreased pain

Secondary Outcome Measures

Name	Time	Method
Improve lung function	1 month	To determined if PEP improves functional sequelae secondary to thoracic trauma.
Reduce hospital stay	1 month	To assess if PEP decreased hospital stay
Resolution of pleural lesions	1 month	To analysed if PEP allows faster resolution of pleural lesions

Trial Locations

Locations (1)

Inmaculada Castillo; 🇪🇸 Seva, Barcelona, Spain