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IS Reduces Rib Fracture Complications

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04006587
Enrollment
50
Registered
2019-07-05
Start date
2014-06-01
Completion date
2017-06-01
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemothorax; Traumatic, Rib Fractures, Rib Trauma

Keywords

incentive spirometer, Hemothorax; Traumatic, trauma, rib Fractures

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.

Interventions

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pulmonary complication rate2 weeks after traumaatelectasis, pneumonia, hemothorax, and pneumothorax

Secondary

MeasureTime frameDescription
1st lung function test2nd day of admissionforced vital capacity and forced expiratory volume in 1 second
2nd lung function test7th day of admissionforced vital capacity and forced expiratory volume in 1 second
length of hospital staytotal hospital stay days up to 2 months after admissiontotal stay in hospital after trauma
1st Pain score1st day of admissionNumerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)
2nd Pain score5th day of admissionNumerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026