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

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.

Study Overview

• Status: Completed
• Conditions: Trauma Chest
• Intervention / Treatment: Device: PEP bottle

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Seva, Barcelona, Spain, 08553
      • Inmaculada Castillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve the degree of pain	To assess if PEP decreased pain	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of pleural lesions	To analysed if PEP allows faster resolution of pleural lesions	1 month
Improve lung function	To determined if PEP improves functional sequelae secondary to thoracic trauma.	1 month
Reduce hospital stay	To assess if PEP decreased hospital stay	1 month

Collaborators and Investigators

• Sponsor: Hospital de Granollers
• Investigators: Study Chair: Gemma Molist, Hospital de Granollers

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries
• Other Study ID Numbers: Incentive Spirometry vs PEP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No