Clinical trial NCT04548466: Effect of Positive Expiratory Pressure on the Management of Chest Trauma
Official title: Effect of Positive Expiratory Pressure on the Management of Chest Trauma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Fracture
Lead sponsor: Hospital de Granollers
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aid secretion clearance
timeFrame: 1 month
Secondary outcomes:
measure: Resolution of pleural lesions
timeFrame: 1 month
measure: Improve lung function
timeFrame: 1 month
measure: Reduce hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Seva
country: Spain
facility: Inmaculada Castillo
state: Barcelona
Study officials:
affiliation: Hospital de Granollers
name: Gemma Molist
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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. doi: 10.1136/emj.2004.019786.
citation: Sehlin M, Ohberg F, Johansson G, Winso 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.