---
title: A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma
nct_id: NCT04548479
overall_status: COMPLETED
phase: NA
sponsor: Hospital de Granollers
study_type: INTERVENTIONAL
primary_condition: Trauma Chest
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04548479.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04548479"
ct_last_update_post_date: 2023-04-14
last_seen_at: "2026-05-12T06:59:14.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Comparative Study of Incentive Spirometry and Positive Expiratory Pressure in Chest Trauma

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

**NCT ID:** [NCT04548479](https://clinicaltrials.gov/study/NCT04548479)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Hospital de Granollers
- **Conditions:** Trauma Chest
- **Start Date:** 2020-03-03
- **Completion Date:** 2022-09-01
- **CT.gov Last Update:** 2023-04-14

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 88 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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
- **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 bottle** (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.

## Primary Outcomes

- **Improve the degree of pain** _(time frame: 1 month)_ — To assess if PEP decreased pain

## Secondary Outcomes

- **Resolution of pleural lesions** _(time frame: 1 month)_
- **Improve lung function** _(time frame: 1 month)_
- **Reduce hospital stay** _(time frame: 1 month)_

## Locations (1)

- Inmaculada Castillo, Seva, Barcelona, Spain

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.inmaculada castillo|seva|barcelona|spain` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04548479*  
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