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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
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemothorax; Traumatic focused on measuring incentive spirometer, Hemothorax; Traumatic, trauma, rib Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 27, 2019
    Last Updated
    July 2, 2019
    Sponsor
    Chang Gung Memorial Hospital
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    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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