Evaluating the Effectiveness of Incentive Spirometry

NCT02952027 | Completed

• 1 other identifier: Lifespan
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea; Respiratory Rate; Oxygen Saturation; Oxygen Requirements; FEV1; FVC; Atelectasis; Pneumonia; Re-intubation; Hospital Length of Stay; Nursing Workload; Incentive Spirometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Outcomes - Does IS use compliance improve clinical outcomes?

  up to 1 week postoperatively

Study Arms (2)

Bell On

EXPERIMENTAL

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

Bell Off

PLACEBO COMPARATOR

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

Interventions

Use-recording, patient-reminder alarm for incentive spirometry BEHAVIORAL

Bell Off; Bell On

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Lifespan: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, United States

Location

Related Publications (12)

• 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.

  PMID: 22972072 BACKGROUND

• 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.

  PMID: 24510642 BACKGROUND

• 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.

  PMID: 26909010 BACKGROUND

• 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.

  PMID: 8669602 BACKGROUND

• 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.

  PMID: 16618955 BACKGROUND

• 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.

  PMID: 21045639 BACKGROUND

• 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.

  PMID: 8211699 BACKGROUND

• 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.

  PMID: 21572323 BACKGROUND

• 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.

  PMID: 16606377 BACKGROUND

• 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.

  PMID: 19627688 BACKGROUND

• Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.

  PMID: 22008401 BACKGROUND

• 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.

  PMID: 30969332 DERIVED

MeSH Terms

Conditions

Dyspnea; Pulmonary Atelectasis; Pneumonia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Infections; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: November 2, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

US (1)