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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Dyspnea; Atelectasis; Respiratory Rate; Oxygen Saturation; Oxygen Requirements; FEV1; FVC; Re-intubation; Hospital Length of Stay; Nursing Workload; Incentive Spirometry
• Intervention / Treatment: Behavioral: Use-recording, patient-reminder alarm for incentive spirometry

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 1 week postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes - Does IS use compliance improve clinical outcomes?	Subjective American Thoracic Society's Dyspnea Index43 - administered daily in ICTUICTU Day 1: Baseline Dyspnea IndexICTU Day 2 through discharge: Transition Dyspnea Index; Objective Trend during ICTU stayVital signs (T, HR, RR, BP)O2 saturationOxygen requirementsCBC Bedside Pulmonary Function Tests (Micro 1, Carefusion)Daily FEV1, FVC, FEV6, PEF, FEV1/FVC, FEV1/FEV6 and F25-75 ratios. Wilcox atelectasis severity score44, 45Scored 0-5 by daily chest x-rayCollaboration with Dr. Terrance Healy, Chief of Chest Radiology, RIH PneumoniaRate of physician-diagnosed pneumoniaPneumonia severity index48 Length of ICTU stay MortalityIn-hospital30 day post-discharge 30-day readmission rates	up to 1 week postoperatively

Collaborators and Investigators

• Sponsor: Lifespan

Publications and helpful links

General Publications

• Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
• Khan NA, Quan H, Bugar JM, Lemaire JB, Brant R, Ghali WA. Association of postoperative complications with hospital costs and length of stay in a tertiary care center. J Gen Intern Med. 2006 Feb;21(2):177-80. doi: 10.1111/j.1525-1497.2006.00319.x.
• Freitas ER, Soares BG, Cardoso JR, Atallah AN. Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD004466. doi: 10.1002/14651858.CD004466.pub3.
• do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.
• 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.
• 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.
• Qaseem A, Snow V, Fitterman N, Hornbake ER, Lawrence VA, Smetana GW, Weiss K, Owens DK, Aronson M, Barry P, Casey DE Jr, Cross JT Jr, Fitterman N, Sherif KD, Weiss KB; Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Risk assessment for and strategies to reduce perioperative pulmonary complications for patients undergoing noncardiothoracic surgery: a guideline from the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):575-80. doi: 10.7326/0003-4819-144-8-200604180-00008.
• 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.
• 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.
• Agostini P, Singh S. Incentive spirometry following thoracic surgery: what should we be doing? Physiotherapy. 2009 Jun;95(2):76-82. doi: 10.1016/j.physio.2008.11.003. Epub 2009 Mar 3.
• Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
• Eltorai AEM, Baird GL, Eltorai AS, Healey TT, Agarwal S, Ventetuolo CE, Martin TJ, Chen J, Kazemi L, Keable CA, Diaz E, Pangborn J, Fox J, Connors K, Sellke FW, Elias JA, Daniels AH. Effect of an Incentive Spirometer Patient Reminder After Coronary Artery Bypass Grafting: A Randomized Clinical Trial. JAMA Surg. 2019 Jul 1;154(7):579-588. doi: 10.1001/jamasurg.2019.0520.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 29, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Pulmonary Atelectasis; Dyspnea
• Other Study ID Numbers: Lifespan