IS Reduces Rib Fracture Complications

Study Overview
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Brief Summary
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The incentive spirometer (IS) is a mechanical device that helps lung expansion. It is commonly used to prevent postoperative lung atelectasis and decreased pulmonary complications in patients who received cardiac, lung, or abdomen surgery.This study aimed to explore the effect of the IS on the improvement of lung function and decrease in pulmonary complication rate in rib fractures patients.

Detailed Description
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Adult patients (>18 years old) seen at our institution between June, 2014 until May, 2017 with traumatic rib fractures were included. For inclusion, a patient had to have at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan. We excluded patients with unconsciousness, history of chronic obstructive pulmonary disease, asthma, or an Injury Severity Score (ISS) ≥ 16. Patients were divided into two groups using a randomized envelope technique: in the study group, patients were advised to use the IS and in the control group patients did not received the IS. All patients were managed with the same oral analgesic protocol. A CXR was obtained on the 1st and 5th day of admission and performed by a radiologist. The Pulmonary Function Test (PFT) was administered on the 2nd and 7th day of admission and performed by a pulmonologist. A numeric rating scale (NRS) was used to define the severity of chest pain on the 1st and 5th day of admission.

Official Title
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Incentive Spirometer Device Reduces Pulmonary Complications in Patients With Traumatic Rib Fractures

Conditions
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Hemothorax; Traumatic, Rib Fractures, Rib Trauma

Intervention / Treatment
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* Device: incentive spirometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan Exclusion Criteria: unconsciousness, history of chronic obstructive pulmonary disease asthma Injury Severity Score (ISS) ≥ 16

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IS intervention<br>patients were instructed how to use the IS in a seated or semi-seated position, and to maintain sustained maximal inspiration for 3-5 seconds before exhalation, ten times per hour, and for at least eight hours a day. | Device: incentive spirometer<br>* patients were instructed how to use the IS in a seated or semi-seated position, and to maintain sustained maximal inspiration for 3-5 seconds before exhalation, ten times per hour, and for at least eight hours a day.<br>|
| No Intervention: control<br>standard care without IS intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary complication rate | atelectasis, pneumonia, hemothorax, and pneumothorax | 2 weeks after trauma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st lung function test | forced vital capacity and forced expiratory volume in 1 second | 2nd day of admission | 
| 2nd lung function test | forced vital capacity and forced expiratory volume in 1 second | 7th day of admission | 
| length of hospital stay | total stay in hospital after trauma | total hospital stay days up to 2 months after admission | 
| 1st Pain score | Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain) | 1st day of admission | 
| 2nd Pain score | Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain) | 5th day of admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incentive spirometer, Hemothorax; Traumatic, trauma, rib Fractures