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出境医 / 临床实验 / IS Reduces Rib Fracture Complications

IS Reduces Rib Fracture Complications

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.

Condition or disease Intervention/treatment Phase
Hemothorax; Traumatic Rib Fractures Rib Trauma Device: incentive spirometer Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Incentive Spirometer Device Reduces Pulmonary Complications in Patients With Traumatic Rib Fractures
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : June 1, 2017
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. pulmonary complication rate [ Time Frame: 2 weeks after trauma ]
    atelectasis, pneumonia, hemothorax, and pneumothorax


Secondary Outcome Measures :
  1. 1st lung function test [ Time Frame: 2nd day of admission ]
    forced vital capacity and forced expiratory volume in 1 second

  2. 2nd lung function test [ Time Frame: 7th day of admission ]
    forced vital capacity and forced expiratory volume in 1 second

  3. length of hospital stay [ Time Frame: total hospital stay days up to 2 months after admission ]
    total stay in hospital after trauma

  4. 1st Pain score [ Time Frame: 1st day of admission ]
    Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)

  5. 2nd Pain score [ Time Frame: 5th day of admission ]
    Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE June 1, 2014
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		pulmonary complication rate [ Time Frame: 2 weeks after trauma ]
atelectasis, pneumonia, hemothorax, and pneumothorax
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 1st lung function test [ Time Frame: 2nd day of admission ]
    forced vital capacity and forced expiratory volume in 1 second
  • 2nd lung function test [ Time Frame: 7th day of admission ]
    forced vital capacity and forced expiratory volume in 1 second
  • length of hospital stay [ Time Frame: total hospital stay days up to 2 months after admission ]
    total stay in hospital after trauma
  • 1st Pain score [ Time Frame: 1st day of admission ]
    Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)
  • 2nd Pain score [ Time Frame: 5th day of admission ]
    Numerical Pain Rating Scale of chest pain, from 0 (no pain) to 10 (worst pain)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IS Reduces Rib Fracture Complications
Official Title  ICMJE Incentive Spirometer Device Reduces Pulmonary Complications in Patients With Traumatic Rib Fractures
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Hemothorax; Traumatic
  • Rib Fractures
  • Rib Trauma
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: incentive spirometer
  • No Intervention: control
    standard care without IS intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019) 		50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2017
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04006587
Other Study ID Numbers  ICMJE CMRPG 2E0221
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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