Evaluating the Effectiveness of Incentive Spirometry

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.

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Key information

Conditions

Dyspnea Atelectasis FEV1 FVC Hospital Length of Stay Incentive Spirometry Infections Lung Diseases Nursing Workload Oxygen Requirements Oxygen Saturation Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Atelectasis Re-intubation Respiration Disorders Respiratory Rate Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Use-recording, patient-reminder alarm for incentive spirometry

Behavioral

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Lifespan

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Nov 2, 2016
Registry last updated: Aug 7, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed