DyspneaNCT02952027
Evaluating the Effectiveness of Incentive Spirometry
A study testing Use-recording, patient-reminder alarm for incentive spirometry in people with Dyspnea and Respiratory Rate, run by Lifespan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Respiratory Rate, Oxygen Saturation
- What is being tested?
- Use-recording, patient-reminder alarm for incentive spirometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Use-recording, patient-reminder alarm for incentive spirometry
- Medical subject headings
- Dyspnea, Pulmonary Atelectasis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use-recording, patient-reminder alarm for incentive spirometryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Bell On | Experimental | Subjects in the Bell On arm will receive a timer where the alarm will sound every hour. Receives: 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 Receives: Behavioral: Use-recording, patient-reminder alarm for incentive spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 week postoperatively
Secondary outcomes (1)
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
Measured: up to 1 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Eltorai, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952027
- Sponsor's protocol ID
- Lifespan
- Status last verified
- Aug 2018
- First submitted
- 18 Oct 2016
- Last updated
- 7 Aug 2018
- Results posted
- No
Publications
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.
PubMed 22972072do 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.
PubMed 24510642Narayanan 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.
PubMed 26909010Joyce 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.
PubMed 8669602Qaseem 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.
PubMed 16618955Canet 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.
PubMed 21045639Ephgrave 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.
PubMed 8211699Shander 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.
PubMed 21572323Khan 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.
PubMed 16606377Agostini 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.
PubMed 19627688Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
PubMed 22008401Eltorai 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.
PubMed 30969332
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Incentive Spirometry
- ClinicalTrials.gov ID
- NCT02952027
- Acronym / sponsor ID
- Lifespan
- Conditions
- Dyspnea, Respiratory Rate, Oxygen Saturation, Oxygen Requirements, FEV1, FVC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bell On | Experimental | Behavioral: Use-recording, patient-reminder alarm for incentive spirometrySubjects in the Bell On arm will receive a timer where the alarm will sound every hour. |
| Bell Off | Placebo comparator | Behavioral: Use-recording, patient-reminder alarm for incentive spirometrySubjects in the Bell Off arm will receive a timer where the alarm will not sound, but still record incentive spirometer usage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use-recording, patient-reminder alarm for incentive spirometry | Behavioural | Bell Off, Bell On |
Primary outcome
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.
1 secondary outcome
Outcomes - Does IS use compliance improve clinical outcomes?
Time frame: up to 1 week postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Background: PubMed 22972072Freitas 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.
- Background: PubMed 24510642do 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.
- Background: PubMed 26909010Narayanan 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.
- Background: PubMed 8669602Joyce 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.
- Background: PubMed 16618955Qaseem 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.
- Background: PubMed 21045639Canet 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.
- Background: PubMed 8211699Ephgrave 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.
- Background: PubMed 21572323Shander 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.
- Background: PubMed 16606377Khan 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.
- Background: PubMed 19627688Agostini 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.
- Background: PubMed 22008401Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
- Derived from this study: PubMed 30969332Eltorai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use-recording, patient-reminder alarm for incentive spirometry in people with Dyspnea and Respiratory Rate, run by Lifespan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance - Does the alarm improve IS use compliance? (time frame: up to 1 week postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02952027, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.