An interventional study of incentive spirometer in Hemothorax; Traumatic, Rib Fractures and Rib Trauma, sponsored by Chang Gung Memorial Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Prevention
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.
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.
26 studies on the registry are indexed under Hemothorax; 5 are open to participants now.
This study's enrollment of 50 is below the median of 81 across 22 interventional studies indexed under Hemothorax.
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Exclusion Criteria:
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
standard care without IS intervention
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.
pulmonary complication rate
atelectasis, pneumonia, hemothorax, and pneumothorax
Time frame: 2 weeks after trauma
1st lung function test
forced vital capacity and forced expiratory volume in 1 second
Time frame: 2nd day of admission
2nd lung function test
forced vital capacity and forced expiratory volume in 1 second
Time frame: 7th day of admission
length of hospital stay
total stay in hospital after trauma
Time frame: 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)
Time frame: 1st day of admission
2nd Pain score
Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)
Time frame: 5th day of admission
No study locations are listed for this record.
Plan to share: No
Ran from Jun 2014 to primary completion in May 2017, 35 months.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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