IS Reduces Rib Fracture Complications

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006587
• Other study ID #: CMRPG 2E0221
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: June 1, 2017

Study information

• Verified date: June 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hemothorax
• Hemothorax; Traumatic
• Rib Fractures
• Rib Trauma

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary complication rate	atelectasis, pneumonia, hemothorax, and pneumothorax	2 weeks after trauma
Secondary	1st lung function test	forced vital capacity and forced expiratory volume in 1 second	2nd day of admission
Secondary	2nd lung function test	forced vital capacity and forced expiratory volume in 1 second	7th day of admission
Secondary	length of hospital stay	total stay in hospital after trauma	total hospital stay days up to 2 months after admission
Secondary	1st Pain score	Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)	1st day of admission
Secondary	2nd Pain score	Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)	5th day of admission