NCT04548479

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

2.5 years

First QC Date

September 7, 2020

Last Update Submit

April 12, 2023

Conditions

Trauma Chest

Outcome Measures

Primary Outcomes (1)

  • Improve the degree of pain

    To assess if PEP decreased pain

    1 month

Secondary Outcomes (3)

  • Resolution of pleural lesions

    1 month

  • Improve lung function

    1 month

  • Reduce hospital stay

    1 month

Study Arms (2)

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

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

Interventions

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.

PEP group

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chest trauma of 3 or more rib fractures with or without hemopneumothorax
  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inmaculada Castillo

Seva, Barcelona, 08553, Spain

Location

Related Publications (5)

  • 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.

    PMID: 11555536BACKGROUND

  • 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.

    PMID: 23114493BACKGROUND

  • 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.

    PMID: 25887859BACKGROUND

  • 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.

    PMID: 15843697BACKGROUND

  • 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.

    PMID: 17650355BACKGROUND

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Gemma Molist

    Hospital de Granollers

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Los evaluadores de los resultados y el investigador que realiza la aleatorización
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: aleatorizado 1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

March 3, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

ES(1)