Clinical trial NCT06304493: REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)
Official title: Postoperative Utilization of Incentive Spirometry With and Without Electronic Patient Reminders in the Post-Anesthesia Care Unit (PACU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Atelectasis
Postoperative Hypoxemia
Postoperative Pneumonia
Postoperative Pulmonary Complications
Patient Adherence
Incentive Spirometry
Respiratory Therapy
Respiratory Insufficiency
Keywords: Incentive Spirometry
Postoperative Pulmonary Complications
Postoperative Standard-Of-Care
standard-of-care after surgery
Deep Breathing
Patient Reminders
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* be 18 years or older;
* have undergone a surgical procedure at the University of Colorado Hospital under general anesthesia;
* 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;
* 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.

Exclusion Criteria:

* have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual signals of the InSee monitor;
* 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);
* are a part of a vulnerable population (e.g., pregnant, minors, prisoners).

Primary outcomes:
measure: Rate of adequate IS breaths achieved in PACU
timeFrame: PACU stay (up to 3 hours)
Secondary outcomes:
measure: Rate of IS breaths attempted in PACU
timeFrame: PACU stay (up to 3 hours)
measure: Time to first adequate IS breath
timeFrame: PACU stay (up to 3 hours)
measure: Duration of postoperative O2 therapy
timeFrame: Hospital stay (up to first 3 postoperative days)
measure: Presence of postoperative pulmonary complications
timeFrame: Hospital stay (up to first 3 postoperative days)
measure: Individual postoperative pulmonary complications
timeFrame: Hospital stay (up to first 3 postoperative days)
measure: Need for ICU Admission after PACU
timeFrame: Hospital stay (up to first 3 postoperative days)
measure: PACU Length of Stay
timeFrame: PACU stay
Other outcomes:
Locations:
city: Aurora
country: United States
facility: CU Anschutz
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Ana Fernandez-Bustamante, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.