Effect of Positive Expiratory Pressure on the Management of Chest Trauma
Primary Purpose
Thoracic Fracture
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PEP bottle
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Fracture
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.
Sites / Locations
- Inmaculada Castillo
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL group
PEP group
Arm 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.
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)
Outcomes
Primary Outcome Measures
Aid secretion clearance
To determine if PEP bottle improves the secretion clearance
Secondary Outcome Measures
Resolution of pleural lesions
To analysed if PEP bottle allows faster resolution of pleural lesions
Improve lung function
To determine if PEP bottle improves lung function tests
Reduce hospital stay
To assess if PEP bottle decreased hospital stay
Full Information
NCT ID
NCT04548466
First Posted
September 7, 2020
Last Updated
September 11, 2020
Sponsor
Hospital de Granollers
1. Study Identification
Unique Protocol Identification Number
NCT04548466
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Granollers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONTROL group
Arm Type
No Intervention
Arm 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.
Arm Title
PEP group
Arm Type
Experimental
Arm 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 breathing (PEP bottle)
Intervention Type
Device
Intervention Name(s)
PEP bottle
Primary Outcome Measure Information:
Title
Aid secretion clearance
Description
To determine if PEP bottle improves the secretion clearance
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Resolution of pleural lesions
Description
To analysed if PEP bottle allows faster resolution of pleural lesions
Time Frame
1 month
Title
Improve lung function
Description
To determine if PEP bottle improves lung function tests
Time Frame
1 month
Title
Reduce hospital stay
Description
To assess if PEP bottle decreased hospital stay
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma Molist
Organizational Affiliation
Hospital de Granollers
Official's Role
Study Chair
Facility Information:
Facility Name
Inmaculada Castillo
City
Seva
State/Province
Barcelona
ZIP/Postal Code
08553
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32417043
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.
Results Reference
background
PubMed Identifier
31856165
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.
Results Reference
background
PubMed Identifier
30940753
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.
Results Reference
background
PubMed Identifier
29766081
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.
Results Reference
background
PubMed Identifier
15843697
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.
Results Reference
background
PubMed Identifier
17650355
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.
Results Reference
background
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Effect of Positive Expiratory Pressure on the Management of Chest Trauma
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