IS Reduces Rib Fracture Complications

Not Applicable

Completed

• Conditions: Rib Trauma; Hemothorax; Traumatic; Rib Fractures
• Interventions: Device: incentive spirometer

• Registration Number: NCT04006587
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-06-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-02
• Last Update Submitted: 2019-07-02
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IS intervention	incentive spirometer	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.

Primary Outcome Measures

Name	Time	Method
pulmonary complication rate	2 weeks after trauma	atelectasis, pneumonia, hemothorax, and pneumothorax

Secondary Outcome Measures

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