Trauma ChestNCT04548479
A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma
A study testing PEP bottle in people with Trauma Chest, run by Hospital de Granollers at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Trauma Chest
- 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
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2020to 1 Sep 2022
- 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 of 3 or more rib fractures with or without hemopneumothorax
- Signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Patients With Chest Trauma: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Trauma Chest
- Being tested
- PEP bottle
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP bottleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PEP group | Active comparator | 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 Receives: Device: PEP bottle |
| INS 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. 5. Inspiratory incentive spirometry breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the degree of pain
To assess if PEP decreased pain
Measured: 1 month
Secondary outcomes (3)
Resolution of pleural lesions
To analysed if PEP allows faster resolution of pleural lesions
Measured: 1 month
Improve lung function
To determined if PEP improves functional sequelae secondary to thoracic trauma.
Measured: 1 month
Reduce hospital stay
To assess if PEP 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 start3 Mar 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trauma ChestStudies 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
- Model description
- aleatorizado 1:1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 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
- NCT04548479
- Sponsor's protocol ID
- Incentive Spirometry vs PEP
- Status last verified
- Apr 2023
- First submitted
- 7 Sep 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11555536Simon 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.
PubMed 23114493Unsworth 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.
PubMed 25887859Gunduz 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Patients With Chest Trauma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04548479
- Acronym / sponsor ID
- Incentive Spirometry vs PEP
- Conditions
- Trauma Chest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- aleatorizado 1:1
| Arm | Type | Receives |
|---|---|---|
| PEP group | Active comparator | 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 (PEP) breathing |
| INS 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. 5. Inspiratory incentive spirometry breathing |
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 of 3 or more rib fractures with or without hemopneumothorax
- Signed informed consent.
Key exclusion criteria (6 listed)
- 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.
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 bottlePEP bottle: it will be performed with a bottle of distilled water and a plastic tube, where the patient breathes against a resistance during expiration. | Device | PEP group |
Primary outcome
Improve the degree of pain
Time frame: 1 month
To assess if PEP decreased pain
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 Apr 2023.
- Background: PubMed 11555536Overend 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.
- Background: PubMed 23114493Simon 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.
- Background: PubMed 25887859Unsworth 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.
- 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 Trauma Chest, 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 6 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 Apr 2023. 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?
Improve the degree of pain (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 NCT04548479, which also lists 5 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 Apr 2023.