Evaluating the Effectiveness of Incentive Spirometry

Pneumonia Clinical Trial

Official title:

Evaluating the Effectiveness of Incentive Spirometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952027
• Other study ID #: Lifespan
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2018

Study information

• Verified date: August 2018
• Source: Lifespan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Use-recording, patient-reminder alarm for incentive spirometry

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Lifespan

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. Review. — View Citation

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté 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. — View Citation

do Nascimento Junior P, Módolo NS, Andrade S, Guimarães 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;(2):CD006058. doi: 10.1002/14651858.CD006058.pub3. Review. — View 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. — View Citation

Freitas ER, Soares BG, Cardoso JR, Atallah ÁN. Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD004466. doi: 10.1002/14651858.CD004466.pub3. Review. — View 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. Review. — View Citation

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. — View 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. Review. — View Citation

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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 - 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	up to 1 week postoperatively