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Evaluating the Effectiveness of Incentive Spirometry

Primary Purpose

Dyspnea, Respiratory Rate, Oxygen Saturation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use-recording, patient-reminder alarm for incentive spirometry
Sponsored by
Lifespan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyspnea

Eligibility Criteria

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

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.

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bell On

Bell Off

Arm Description

Subjects in the Bell On arm will receive a timer where the alarm will sound every hour.

Subjects in the Bell Off arm will receive a timer where the alarm will not sound, but still record incentive spirometer usage

Outcomes

Primary Outcome Measures

Compliance - Does the alarm improve IS use compliance?
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

Outcomes - Does IS use compliance improve clinical outcomes?
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

Full Information

First Posted
October 18, 2016
Last Updated
August 6, 2018
Sponsor
Lifespan
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1. Study Identification

Unique Protocol Identification Number
NCT02952027
Brief Title
Evaluating the Effectiveness of Incentive Spirometry
Official Title
Evaluating the Effectiveness of Incentive Spirometry
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Respiratory Rate, Oxygen Saturation, Oxygen Requirements, FEV1, FVC, Atelectasis, Pneumonia, Re-intubation, Hospital Length of Stay, Nursing Workload, Incentive Spirometry

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bell On
Arm Type
Experimental
Arm Description
Subjects in the Bell On arm will receive a timer where the alarm will sound every hour.
Arm Title
Bell Off
Arm Type
Placebo Comparator
Arm Description
Subjects in the Bell Off arm will receive a timer where the alarm will not sound, but still record incentive spirometer usage
Intervention Type
Behavioral
Intervention Name(s)
Use-recording, patient-reminder alarm for incentive spirometry
Primary Outcome Measure Information:
Title
Compliance - Does the alarm improve IS use compliance?
Description
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.
Time Frame
up to 1 week postoperatively
Secondary Outcome Measure Information:
Title
Outcomes - Does IS use compliance improve clinical outcomes?
Description
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
Time Frame
up to 1 week postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22972072
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
26909010
Citation
Narayanan AL, Hamid SR, Supriyanto E. Evidence regarding patient compliance with incentive spirometry interventions after cardiac, thoracic and abdominal surgeries: A systematic literature review. Can J Respir Ther. 2016 Winter;52(1):17-26.
Results Reference
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PubMed Identifier
8669602
Citation
Joyce CJ, Baker AB. What is the role of absorption atelectasis in the genesis of perioperative pulmonary collapse? Anaesth Intensive Care. 1995 Dec;23(6):691-6. doi: 10.1177/0310057X9502300606.
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PubMed Identifier
16618955
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
8211699
Citation
Ephgrave KS, Kleiman-Wexler R, Pfaller M, Booth B, Werkmeister L, Young S. Postoperative pneumonia: a prospective study of risk factors and morbidity. Surgery. 1993 Oct;114(4):815-9; discussion 819-21.
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PubMed Identifier
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Citation
Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011 Sep;39(9):2163-72. doi: 10.1097/CCM.0b013e31821f0522.
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PubMed Identifier
16606377
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
derived

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Evaluating the Effectiveness of Incentive Spirometry

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