IS Reduces Rib Fracture Complications

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

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.

Study Overview

• Status: Completed
• Conditions: Rib Fractures; Hemothorax; Traumatic; Rib Trauma
• Intervention / Treatment: Device: incentive spirometer

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: control; standard care without IS intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• Sum SK, Peng YC, Yin SY, Huang PF, Wang YC, Chen TP, Tung HH, Yeh CH. Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial. Trials. 2019 Dec 30;20(1):797. doi: 10.1186/s13063-019-3943-x.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: trauma; incentive spirometer; Hemothorax; Traumatic; rib Fractures
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Wounds and Injuries; Pleural Diseases; Hemorrhage; Thoracic Injuries; Hemothorax; Fractures, Bone; Rib Fractures
• Other Study ID Numbers: CMRPG 2E0221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No