A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma

NCT ID: NCT04548479

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2022-09-01

Brief Summary

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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

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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

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Trauma Chest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

aleatorizado 1:1
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Los evaluadores de los resultados y el investigador que realiza la aleatorización

Study Groups

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PEP group

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

Group Type ACTIVE_COMPARATOR

PEP bottle

Intervention Type DEVICE

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.

INS group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PEP bottle

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Granollers

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gemma Molist

Role: STUDY_CHAIR

Hospital de Granollers

Locations

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Inmaculada Castillo

Seva, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 11555536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23114493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25887859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15843697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17650355 (View on PubMed)

Other Identifiers

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Incentive Spirometry vs PEP

Identifier Type: -

Identifier Source: org_study_id

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