Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 4:15 AM
Study NCT ID:
NCT06304493
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2024-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056902', 'term': 'Clinical Alarms'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome collection and data analysis will be performed by investigators blinded to the patient\'s cluster allocation (alarms "ON" or "OFF").'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a pragmatic single-center cluster study of surgical patients receiving incentive spirometry devices during their PACU stay, with either automatic alarms "ON" or "OFF" in alternating weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adequate IS breaths achieved in PACU', 'timeFrame': 'PACU stay (up to 3 hours)', 'description': 'Rate of adequate incentive spirometry breaths achieved by patients per hour for up to 3 hours during the PACU stay'}], 'secondaryOutcomes': [{'measure': 'Rate of IS breaths attempted in PACU', 'timeFrame': 'PACU stay (up to 3 hours)', 'description': 'Rate of incentive spirometry breaths attempted by patients per hour for up to 3 hours during the PACU stay'}, {'measure': 'Time to first adequate IS breath', 'timeFrame': 'PACU stay (up to 3 hours)', 'description': 'The time it takes for the patient to achieve their first adequate IS breath, from the moment of being provided the IS device and instructions of use onward, during their PACU stay'}, {'measure': 'Duration of postoperative O2 therapy', 'timeFrame': 'Hospital stay (up to first 3 postoperative days)', 'description': 'The total postoperative length of oxygen therapy use from the time the patient arrives to PACU to the end of their O2 therapy'}, {'measure': 'Presence of postoperative pulmonary complications', 'timeFrame': 'Hospital stay (up to first 3 postoperative days)', 'description': 'The number of study participants developing any pulmonary complications (including pneumonia, need for non-invasive ventilation (CPAP/BiPAP or reintubation for any reason and any duration) during the first 3 postoperative days'}, {'measure': 'Individual postoperative pulmonary complications', 'timeFrame': 'Hospital stay (up to first 3 postoperative days)', 'description': 'The number of study participants developing each pulmonary complication (pneumonia, need for non-invasive ventilation (CPAP/BiPAP or reintubation for any reason and any duration) during the first 3 postoperative days'}, {'measure': 'Need for ICU Admission after PACU', 'timeFrame': 'Hospital stay (up to first 3 postoperative days)', 'description': 'The frequency of patients requiring ICU admission immediately after their PACU stay'}, {'measure': 'PACU Length of Stay', 'timeFrame': 'PACU stay', 'description': 'The length of stay in the PACU'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Incentive Spirometry', 'Postoperative Pulmonary Complications', 'Postoperative Standard-Of-Care', 'standard-of-care after surgery', 'Deep Breathing', 'Patient Reminders'], 'conditions': ['Postoperative Atelectasis', 'Postoperative Hypoxemia', 'Postoperative Pneumonia', 'Postoperative Pulmonary Complications', 'Patient Adherence', 'Incentive Spirometry', 'Respiratory Therapy', 'Respiratory Insufficiency']}, 'referencesModule': {'references': [{'pmid': '27829093', 'type': 'BACKGROUND', 'citation': 'Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.'}, {'pmid': '21572323', 'type': 'BACKGROUND', '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.'}, {'pmid': '16618957', 'type': 'BACKGROUND', 'citation': 'Lawrence VA, Cornell JE, Smetana GW; American College of Physicians. Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):596-608. doi: 10.7326/0003-4819-144-8-200604180-00011.'}, {'pmid': '34676618', 'type': 'BACKGROUND', 'citation': 'Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22.'}, {'pmid': '24461279', 'type': 'BACKGROUND', 'citation': 'Bergin C, Speroni KG, Travis T, Bergin J, Sheridan MJ, Kelly K, Daniel MG. Effect of preoperative incentive spirometry patient education on patient outcomes in the knee and hip joint replacement population. J Perianesth Nurs. 2014 Feb;29(1):20-7. doi: 10.1016/j.jopan.2013.01.009.'}, {'pmid': '36437210', 'type': 'BACKGROUND', 'citation': 'Chang PC, Chen PH, Chang TH, Chen KH, Jhou HJ, Chou SH, Chang TW. Incentive spirometry is an effective strategy to improve the quality of postoperative care in patients. Asian J Surg. 2023 Sep;46(9):3397-3404. doi: 10.1016/j.asjsur.2022.11.030. Epub 2022 Nov 24.'}, {'pmid': '19638209', 'type': 'BACKGROUND', 'citation': 'Yanez-Brage I, Pita-Fernandez S, Juffe-Stein A, Martinez-Gonzalez U, Pertega-Diaz S, Mauleon-Garcia A. Respiratory physiotherapy and incidence of pulmonary complications in off-pump coronary artery bypass graft surgery: an observational follow-up study. BMC Pulm Med. 2009 Jul 28;9:36. doi: 10.1186/1471-2466-9-36.'}, {'pmid': '23740240', 'type': 'BACKGROUND', 'citation': 'Cassidy MR, Rosenkranz P, McCabe K, Rosen JE, McAneny D. I COUGH: reducing postoperative pulmonary complications with a multidisciplinary patient care program. JAMA Surg. 2013 Aug;148(8):740-5. doi: 10.1001/jamasurg.2013.358.'}, {'pmid': '24510642', 'type': 'BACKGROUND', 'citation': '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': '28097305', 'type': 'BACKGROUND', 'citation': 'Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.'}, {'pmid': '29279365', 'type': 'BACKGROUND', 'citation': 'Eltorai AEM, Szabo AL, Antoci V Jr, Ventetuolo CE, Elias JA, Daniels AH, Hess DR. Clinical Effectiveness of Incentive Spirometry for the Prevention of Postoperative Pulmonary Complications. Respir Care. 2018 Mar;63(3):347-352. doi: 10.4187/respcare.05679. Epub 2017 Dec 26.'}, {'pmid': '28097332', 'type': 'BACKGROUND', 'citation': 'Pantel H, Hwang J, Brams D, Schnelldorfer T, Nepomnayshy D. Effect of Incentive Spirometry on Postoperative Hypoxemia and Pulmonary Complications After Bariatric Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 May 1;152(5):422-428. doi: 10.1001/jamasurg.2016.4981.'}, {'pmid': '28097336', 'type': 'BACKGROUND', 'citation': 'Wesp JA, Duke MC, Farrell TM. Incentive Spirometry After Bariatric Surgery: Yes or No? JAMA Surg. 2017 May 1;152(5):428. doi: 10.1001/jamasurg.2016.4999. No abstract available.'}, {'pmid': '28636722', 'type': 'BACKGROUND', 'citation': 'Fernandez-Bustamante A, Schoen J, Vidal Melo MF. Incentive Spirometry After Bariatric Surgery: The Importance of Patient Compliance. JAMA Surg. 2017 Oct 1;152(10):984-985. doi: 10.1001/jamasurg.2017.1698. No abstract available.'}, {'pmid': '26909010', 'type': 'BACKGROUND', '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.'}, {'pmid': '29362219', 'type': 'BACKGROUND', 'citation': 'Eltorai AEM, Baird GL, Eltorai AS, Pangborn J, Antoci V Jr, Cullen HA, Paquette K, Connors K, Barbaria J, Smeals KJ, Agarwal S, Healey TT, Ventetuolo CE, Sellke FW, Daniels AH. Incentive Spirometry Adherence: A National Survey of Provider Perspectives. Respir Care. 2018 May;63(5):532-537. doi: 10.4187/respcare.05882. Epub 2018 Jan 23.'}, {'pmid': '19626381', 'type': 'BACKGROUND', 'citation': 'Zoremba M, Dette F, Gerlach L, Wolf U, Wulf H. Short-term respiratory physical therapy treatment in the PACU and influence on postoperative lung function in obese adults. Obes Surg. 2009 Oct;19(10):1346-54. doi: 10.1007/s11695-009-9922-7. Epub 2009 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.', 'detailedDescription': 'This is a pragmatic single-center alternating cluster study. We will enroll adult patients who require general anesthesia for surgery and receive an incentive spirometry device during their PACU stay. Automatic alarms to perform incentive spirometry will be set to either "ON" or "OFF" in alternating weeks. The hypothesis is that patients receiving automatic audible and visual alarms will have increased rates of adequate incentive spirometry breaths compared to patients receiving no alarms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* be 18 years or older;\n* have undergone a surgical procedure at the University of Colorado Hospital under general anesthesia;\n* have incentive spirometry ordered by their provider, or incentive spirometry must be part of the study site's standard-of-care which is implemented by hospital staff;\n* not have severe hearing or impaired visual acuity deficiency, in that they cannot hear or see the audible and visual signal of the InSee monitor.\n\nExclusion Criteria:\n\n* have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual signals of the InSee monitor;\n* have the inability to perform incentive spirometry due to refusal, cognitive impairment, neuromuscular weakness, anatomical or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometry device);\n* are a part of a vulnerable population (e.g., pregnant, minors, prisoners)."}, 'identificationModule': {'nctId': 'NCT06304493', 'briefTitle': 'REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Postoperative Utilization of Incentive Spirometry With and Without Electronic Patient Reminders in the Post-Anesthesia Care Unit (PACU)', 'orgStudyIdInfo': {'id': '23-2470'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alarm "ON" Cohort', 'description': 'The "ON" cohort will receive the standard-of-care instructions for IS and information about the auditory and visual reminders. The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.', 'interventionNames': ['Device: Alarms']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Alarm "OFF" Cohort', 'description': 'The "OFF" cohort will receive only the standard-of-care instructions for IS. The "OFF" patients will receive no signals from the InSee monitor attached to their incentive spirometer.', 'interventionNames': ['Device: Alarms']}], 'interventions': [{'name': 'Alarms', 'type': 'DEVICE', 'otherNames': ['Auditory and visual reminders'], 'description': 'The "ON" cohort patients will receive audible and visual signals from the InSee monitor attached to their incentive spirometer every 20 minutes and upon successfully reaching certain achievements.', 'armGroupLabels': ['Alarm "OFF" Cohort', 'Alarm "ON" Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'CU Anschutz', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Ana Fernandez-Bustamante, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}