Effect of Positive Expiratory Pressure on the Management of Chest Trauma

Thoracic Fracture Clinical Trial

Official title:

Effect of Positive Expiratory Pressure on the Management of Chest Trauma: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548466
• Other study ID #: CT-positive expiratory
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2020
• Source: Hospital de Granollers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chest trauma (CT) are a common problem in our environment caused mainly by traffic accidents and causal and domestic accidents among the elderly population. CTs, in some situations, can lead to sequelae such as fibrothorax secondary to hemothorax and / or empyema and residual chronic pain. Clinical regulations and guidelines recommend a guideline for chest physiotherapy (CP) for all patients with rib fractures, but there is little scientific evidence. It would be interesting to establish CP treatment protocols and describe the most appropriate techniques according to the type and stages of thoracic trauma consolidation.

Objective: To evaluate the effect of Positive Expiratory Pressure (PEP) breathing added to conventional CP in terms of aid secretion clearance, pain control, pleuropulmonary radiological abnormalities, restoration of lung function, and admission days in the immediate phase of the CT.

Description:

After acceptance to participate in the study, patients will be computerized randomized into 2 groups:

• PEP group: positive expiratory pressure breathing.

• CONTROL group: conventional CP treatment without positive pressure brething. The period between day 0 and 20 days post-trauma is considered an immediate phase of CT.

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 chest physiotherapist will perform a clinical and secretion assessment using the Seva test 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 breathing with the help of a PEP bottle device. 2-CONTROL group: conventional CP treatment without positive pressure breathing 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• Chest trauma with three or more rib fractures with or without hemopneumothorax

• Failure to meet any exclusion criteria

Exclusion Criteria:

• Non-cooperative patients for not understanding chest physiotherapy techniques.

• Presence of respiratory failure on admission: PaO2 <60mmHg i / or PaCO2> 50mmHg.

• Medical indication for mechanical ventilation or non-invasive ventilatory support.

• Presence of undrained pneumothorax.

• Complications that limit early mobility.

Related Conditions & MeSH terms

• Thoracic Fracture
• Thoracic Injuries

Intervention

Device:
• PEP bottle

Locations

Country	Name	City	State
Spain	Inmaculada Castillo	Seva	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Granollers

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: An overview. Chin J Traumatol. 2020 Jun;23(3):125-138. doi: 10.1016/j.cjtee.2020.04.003. Epub 2020 Apr 20. Review. — View Citation

Gunduz M, Unlugenc H, Ozalevli M, Inanoglu K, Akman H. A comparative study of continuous positive airway pressure (CPAP) and intermittent positive pressure ventilation (IPPV) in patients with flail chest. Emerg Med J. 2005 May;22(5):325-9. — View Citation

Ingoe HM, Coleman E, Eardley W, Rangan A, Hewitt C, McDaid C. Systematic review of systematic reviews for effectiveness of internal fixation for flail chest and rib fractures in adults. BMJ Open. 2019 Apr 1;9(4):e023444. doi: 10.1136/bmjopen-2018-023444. — View Citation

Liebsch C, Seiffert T, Vlcek M, Beer M, Huber-Lang M, Wilke HJ. Patterns of serial rib fractures after blunt chest trauma: An analysis of 380 cases. PLoS One. 2019 Dec 19;14(12):e0224105. doi: 10.1371/journal.pone.0224105. eCollection 2019. — View Citation

Sehlin M, Ohberg F, Johansson G, Winsö O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5. — View Citation

Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aid secretion clearance	To determine if PEP bottle improves the secretion clearance	1 month
Secondary	Resolution of pleural lesions	To analysed if PEP bottle allows faster resolution of pleural lesions	1 month
Secondary	Improve lung function	To determine if PEP bottle improves lung function tests	1 month
Secondary	Reduce hospital stay	To assess if PEP bottle decreased hospital stay	1 month