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Evaluating the Effectiveness of Incentive Spirometry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952027
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Adam Eltorai, Lifespan

Brief Summary:

Post-operative pulmonary complications (PPCs) have a major impact on patients and healthcare expenses. The goal of perioperative respiratory therapy is to improve airway clearance, increase lung volume, and mitigate atelectasis. Incentive spirometers (IS) are ubiquitously used to prevent atelectasis and PPCs-implementation of which requires substantial provider time and healthcare expenses. However, meta-analyses have demonstrated that the effectiveness of ISs is unclear due to poor patient compliance in past studies.

The goal of this investigation is evaluate the effectiveness of IS on post-operative clinical outcomes. The aims of this investigation are to evaluate 1) if IS use compliance can be improved by adding a use-recording patient reminder alarm, and 2) the clinical outcomes of the more compliant IS users vs. the less-compliant IS users.


Condition or disease Intervention/treatment Phase
Dyspnea Respiratory Rate Oxygen Saturation Oxygen Requirements FEV1 FVC Atelectasis Pneumonia Re-intubation Hospital Length of Stay Nursing Workload Incentive Spirometry Behavioral: Use-recording, patient-reminder alarm for incentive spirometry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating the Effectiveness of Incentive Spirometry
Study Start Date : August 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Experimental: Bell On
Subjects in the Bell On arm will receive a timer where the alarm will sound every hour.
Behavioral: Use-recording, patient-reminder alarm for incentive spirometry
Placebo Comparator: Bell Off
Subjects in the Bell Off arm will receive a timer where the alarm will not sound, but still record incentive spirometer usage
Behavioral: Use-recording, patient-reminder alarm for incentive spirometry



Primary Outcome Measures :
  1. Compliance - Does the alarm improve IS use compliance? [ Time Frame: up to 1 week postoperatively ]
    The primary outcome will be to compare subjects' absolute IS usage count and hourly percent compliance in the Bell On arm vs the Bell Off arms.


Secondary Outcome Measures :
  1. Outcomes - Does IS use compliance improve clinical outcomes? [ Time Frame: up to 1 week postoperatively ]
    • Subjective American Thoracic Society's Dyspnea Index43 - administered daily in ICTU

      • ICTU Day 1: Baseline Dyspnea Index
      • ICTU Day 2 through discharge: Transition Dyspnea Index
    • Objective Trend during ICTU stay

      • Vital signs (T, HR, RR, BP)
      • O2 saturation
      • Oxygen requirements
      • CBC Bedside Pulmonary Function Tests (Micro 1, Carefusion)
      • Daily FEV1, FVC, FEV6, PEF, FEV1/FVC, FEV1/FEV6 and F25-75 ratios. Wilcox atelectasis severity score44, 45
      • Scored 0-5 by daily chest x-ray
      • Collaboration with Dr. Terrance Healy, Chief of Chest Radiology, RIH Pneumonia
      • Rate of physician-diagnosed pneumonia
      • Pneumonia severity index48 Length of ICTU stay Mortality
      • In-hospital
      • 30 day post-discharge 30-day readmission rates



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoes any cardiothoracic surgery
  • Is transferred to the cardiothoracic surgery intermediate (step-down) unit at Rhode Island Hospital
  • Already prescribed an incentive spirometer as standard-of-care
  • Followed by any healthcare provider
  • Ability to sign informed consent and comply with all study procedures including follow-up for up to 1 year

Exclusion Criteria:

  • <18 years of age
  • Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952027


Locations
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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States
Sponsors and Collaborators
Lifespan
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adam Eltorai, Research Fellow, Lifespan
ClinicalTrials.gov Identifier: NCT02952027    
Other Study ID Numbers: Lifespan
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Pneumonia
Dyspnea
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Signs and Symptoms, Respiratory