IS Reduces Rib Fracture Complications
Primary Purpose
Hemothorax; Traumatic, Rib Fractures, Rib Trauma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
incentive spirometer
Sponsored by
About this trial
This is an interventional prevention trial for Hemothorax; Traumatic focused on measuring incentive spirometer, Hemothorax; Traumatic, trauma, rib Fractures
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
IS intervention
control
Arm Description
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.
standard care without IS intervention
Outcomes
Primary Outcome Measures
pulmonary complication rate
atelectasis, pneumonia, hemothorax, and pneumothorax
Secondary Outcome Measures
1st lung function test
forced vital capacity and forced expiratory volume in 1 second
2nd lung function test
forced vital capacity and forced expiratory volume in 1 second
length of hospital stay
total stay in hospital after trauma
1st Pain score
Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)
2nd Pain score
Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)
Full Information
NCT ID
NCT04006587
First Posted
June 27, 2019
Last Updated
July 2, 2019
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04006587
Brief Title
IS Reduces Rib Fracture Complications
Official Title
Incentive Spirometer Device Reduces Pulmonary Complications in Patients With Traumatic Rib Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemothorax; Traumatic, Rib Fractures, Rib Trauma
Keywords
incentive spirometer, Hemothorax; Traumatic, trauma, rib Fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IS intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
standard care without IS intervention
Intervention Type
Device
Intervention Name(s)
incentive spirometer
Intervention Description
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 Measure Information:
Title
pulmonary complication rate
Description
atelectasis, pneumonia, hemothorax, and pneumothorax
Time Frame
2 weeks after trauma
Secondary Outcome Measure Information:
Title
1st lung function test
Description
forced vital capacity and forced expiratory volume in 1 second
Time Frame
2nd day of admission
Title
2nd lung function test
Description
forced vital capacity and forced expiratory volume in 1 second
Time Frame
7th day of admission
Title
length of hospital stay
Description
total stay in hospital after trauma
Time Frame
total hospital stay days up to 2 months after admission
Title
1st Pain score
Description
Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)
Time Frame
1st day of admission
Title
2nd Pain score
Description
Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)
Time Frame
5th day of admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31888765
Citation
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.
Results Reference
derived
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IS Reduces Rib Fracture Complications
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