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

Trauma Chest Clinical Trial

Official title:

A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Patients With Chest Trauma: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548479
• Other study ID #: Incentive Spirometry vs PEP
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2023
• Source: Hospital de Granollers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thoracic Injuries
• Trauma Chest
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Inmaculada Castillo	Seva	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Granollers

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve the degree of pain	To assess if PEP decreased pain	1 month
Secondary	Resolution of pleural lesions	To analysed if PEP allows faster resolution of pleural lesions	1 month
Secondary	Improve lung function	To determined if PEP improves functional sequelae secondary to thoracic trauma.	1 month
Secondary	Reduce hospital stay	To assess if PEP decreased hospital stay	1 month