IS Reduces Rib Fracture Complications
Incentive Spirometer Device Reduces Pulmonary Complications in Patients With Traumatic Rib Fractures
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedJuly 5, 2019
June 1, 2019
3 years
June 27, 2019
July 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pulmonary complication rate
atelectasis, pneumonia, hemothorax, and pneumothorax
2 weeks after trauma
Secondary Outcomes (5)
1st lung function test
2nd day of admission
2nd lung function test
7th day of admission
length of hospital stay
total hospital stay days up to 2 months after admission
1st Pain score
1st day of admission
2nd Pain score
5th day of admission
Study Arms (2)
IS intervention
EXPERIMENTALpatients 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.
control
NO INTERVENTIONstandard care without IS intervention
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.
Eligibility Criteria
You may qualify if:
- at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan
You may not qualify if:
- unconsciousness,
- history of chronic obstructive pulmonary disease
- asthma
- Injury Severity Score (ISS) ≥ 16
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31888765DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2019
First Posted
July 5, 2019
Study Start
June 1, 2014
Primary Completion
May 31, 2017
Study Completion
June 1, 2017
Last Updated
July 5, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share