Thoracic FractureNCT04548466
Effect of Positive Expiratory Pressure on the Management of Chest Trauma
A study testing PEP bottle in people with Thoracic Fracture, run by Hospital de Granollers at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Thoracic Fracture
- What is being tested?
- PEP bottle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chest trauma with three or more rib fractures with or without hemopneumothorax
- Failure to meet any exclusion criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Positive Expiratory Pressure on the Management of Chest Trauma: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Thoracic Fracture
- Being tested
- PEP bottle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP bottleDevice
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: PEP bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aid secretion clearance
To determine if PEP bottle improves the secretion clearance
Measured: 1 month
Secondary outcomes (3)
Resolution of pleural lesions
To analysed if PEP bottle allows faster resolution of pleural lesions
Measured: 1 month
Improve lung function
To determine if PEP bottle improves lung function tests
Measured: 1 month
Reduce hospital stay
To assess if PEP bottle decreased hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thoracic FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gemma Molist, Study chair, Hospital de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548466
- Sponsor's protocol ID
- CT-positive expiratory
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32417043Liebsch 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.
PubMed 31856165Ingoe 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.
PubMed 30940753Witt 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.
PubMed 29766081Gunduz 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.
PubMed 15843697Sehlin 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.
PubMed 17650355
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive Expiratory Pressure on the Management of Chest Trauma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04548466
- Acronym / sponsor ID
- CT-positive expiratory
- Conditions
- Thoracic Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: PEP bottleChest 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) |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chest trauma with three or more rib fractures with or without hemopneumothorax
- Failure to meet any exclusion criteria
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP bottle | Device | PEP group |
Primary outcome
Aid secretion clearance
Time frame: 1 month
To determine if PEP bottle improves the secretion clearance
3 secondary outcomes
Resolution of pleural lesions
Time frame: 1 month
Improve lung function
Time frame: 1 month
Reduce hospital stay
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Background: PubMed 32417043Dogrul 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.
- Background: PubMed 31856165Liebsch 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.
- Background: PubMed 30940753Ingoe 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.
- Background: PubMed 29766081Witt 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.
- Background: PubMed 15843697Gunduz 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.
- Background: PubMed 17650355Sehlin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma Molist study chair
Hospital de Granollers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP bottle in people with Thoracic Fracture, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aid secretion clearance (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04548466, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.