A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma
Primary Purpose
Trauma Chest
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 Trauma Chest
Eligibility Criteria
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.
Sites / Locations
- Inmaculada Castillo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
PEP group
INS 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. 5. Positive expiratory pressure (PEP) breathing
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. Inspiratory incentive spirometry breathing
Outcomes
Primary Outcome Measures
Improve the degree of pain
To assess if PEP decreased pain
Secondary Outcome Measures
Resolution of pleural lesions
To analysed if PEP allows faster resolution of pleural lesions
Improve lung function
To determined if PEP improves functional sequelae secondary to thoracic trauma.
Reduce hospital stay
To assess if PEP decreased hospital stay
Full Information
NCT ID
NCT04548479
First Posted
September 7, 2020
Last Updated
April 12, 2023
Sponsor
Hospital de Granollers
1. Study Identification
Unique Protocol Identification Number
NCT04548479
Brief Title
A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma
Official Title
A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Patients With Chest Trauma: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Chest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
aleatorizado 1:1
Masking
Outcomes Assessor
Masking Description
Los evaluadores de los resultados y el investigador que realiza la aleatorización
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEP group
Arm Type
Active Comparator
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 (PEP) breathing
Arm Title
INS 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. 5. Inspiratory incentive spirometry breathing
Intervention Type
Device
Intervention Name(s)
PEP bottle
Intervention Description
PEP bottle: it will be performed with a bottle of distilled water and a plastic tube, where the patient breathes against a resistance during expiration.
Primary Outcome Measure Information:
Title
Improve the degree of pain
Description
To assess if PEP decreased pain
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Resolution of pleural lesions
Description
To analysed if PEP allows faster resolution of pleural lesions
Time Frame
1 month
Title
Improve lung function
Description
To determined if PEP improves functional sequelae secondary to thoracic trauma.
Time Frame
1 month
Title
Reduce hospital stay
Description
To assess if PEP 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 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.
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
11555536
Citation
Overend TJ, Anderson CM, Lucy SD, Bhatia C, Jonsson BI, Timmermans C. The effect of incentive spirometry on postoperative pulmonary complications: a systematic review. Chest. 2001 Sep;120(3):971-8. doi: 10.1378/chest.120.3.971.
Results Reference
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PubMed Identifier
23114493
Citation
Simon B, Ebert J, Bokhari F, Capella J, Emhoff T, Hayward T 3rd, Rodriguez A, Smith L; Eastern Association for the Surgery of Trauma. Management of pulmonary contusion and flail chest: an Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg. 2012 Nov;73(5 Suppl 4):S351-61. doi: 10.1097/TA.0b013e31827019fd.
Results Reference
background
PubMed Identifier
25887859
Citation
Unsworth A, Curtis K, Asha SE. Treatments for blunt chest trauma and their impact on patient outcomes and health service delivery. Scand J Trauma Resusc Emerg Med. 2015 Feb 8;23:17. doi: 10.1186/s13049-015-0091-5.
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
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A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma
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