Effect of Positive Expiratory Pressure on the Management of Chest Trauma

NCT04548466 | Completed

• 1 other identifier: CT-positive expiratory
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Fracture

Outcome Measures

Primary Outcomes (1)

• Aid secretion clearance

  To determine if PEP bottle improves the secretion clearance

  1 month

Secondary Outcomes (3)

• Resolution of pleural lesions

  1 month

• Improve lung function

  1 month

• Reduce hospital stay

  1 month

Study Arms (2)

CONTROL group

NO INTERVENTION

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.

PEP group

EXPERIMENTAL

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 breathing (PEP bottle)

Device: PEP bottle

Interventions

PEP bottle DEVICE

PEP group

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Inmaculada Castillo

Seva, Barcelona, 08553, Spain

Location

Related 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.

  PMID: 32417043 BACKGROUND

• 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.

  PMID: 31856165 BACKGROUND

• 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.

  PMID: 30940753 BACKGROUND

• 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.

  PMID: 29766081 BACKGROUND

• 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.

  PMID: 15843697 BACKGROUND

• 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.

  PMID: 17650355 BACKGROUND

Study Officials

• Gemma Molist

  Hospital de Granollers

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

ES (1)