Evaluating the Effectiveness of Incentive Spirometry

Not Applicable

Completed

• Conditions: FVC; Atelectasis; Dyspnea; Oxygen Requirements; Re-intubation; Hospital Length of Stay; Nursing Workload; Pneumonia; Incentive Spirometry; Respiratory Rate
• Interventions: Behavioral: Use-recording, patient-reminder alarm for incentive spirometry

• Registration Number: NCT02952027
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-29
• Study First Posted: 2016-11-02
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bell On	Use-recording, patient-reminder alarm for incentive spirometry	Subjects in the Bell On arm will receive a timer where the alarm will sound every hour.
Bell Off	Use-recording, patient-reminder alarm for incentive spirometry	Subjects in the Bell Off arm will receive a timer where the alarm will not sound, but still record incentive spirometer usage

Primary Outcome Measures

Name	Time	Method
Compliance - Does the alarm improve IS use compliance?	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

Name	Time	Method
Outcomes - Does IS use compliance improve clinical outcomes?	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

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States