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OpenTrials
Completed

NCT Number: NCT04006587

IS Reduces Rib Fracture Complications

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.

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Key information

Conditions

Hemothorax; Traumatic Fractures, Bone Hemorrhage Hemothorax Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Respiratory Tract Diseases Rib Fractures Rib Trauma Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incentive spirometer

Device

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 outcomes

  1. pulmonary complication rate

    Time frame: 2 weeks after trauma

    atelectasis, pneumonia, hemothorax, and pneumothorax

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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