REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)

NCT06304493 | Completed FDA Device

• 1 other identifier: 23-2470
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Rate of adequate IS breaths achieved in PACU

  Rate of adequate incentive spirometry breaths achieved by patients per hour for up to 3 hours during the PACU stay

  PACU stay (up to 3 hours)

Secondary Outcomes (7)

• Rate of IS breaths attempted in PACU

  PACU stay (up to 3 hours)

• Time to first adequate IS breath

  PACU stay (up to 3 hours)

• Duration of postoperative O2 therapy

  Hospital stay (up to first 3 postoperative days)

• Presence of postoperative pulmonary complications

  Hospital stay (up to first 3 postoperative days)

• Individual postoperative pulmonary complications

  Hospital stay (up to first 3 postoperative days)

Study Arms (2)

Alarm "ON" Cohort

EXPERIMENTAL

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.

Device: Alarms

Alarm "OFF" Cohort

PLACEBO COMPARATOR

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.

Device: Alarms

Interventions

Alarms DEVICE

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.

Also known as: Auditory and visual reminders

Alarm "OFF" Cohort; Alarm "ON" Cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

CU Anschutz

Aurora, Colorado, 80045, United States

Location

Related Publications (17)

• 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: 27829093 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

• 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: 16618957 BACKGROUND

• 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: 34676618 BACKGROUND

• 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: 24461279 BACKGROUND

• 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: 36437210 BACKGROUND

• 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: 19638209 BACKGROUND

• 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: 23740240 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

• 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: 28097305 BACKGROUND

• 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: 29279365 BACKGROUND

• 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: 28097332 BACKGROUND

• 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: 28097336 BACKGROUND

• 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: 28636722 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

• 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: 29362219 BACKGROUND

• 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.

  PMID: 19626381 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Respiratory Insufficiency

Interventions

Clinical Alarms

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies

Study Officials

• Ana Fernandez-Bustamante, MD, PhD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome collection and data analysis will be performed by investigators blinded to the patient's cluster allocation (alarms "ON" or "OFF").
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 12, 2024
• Study Start: March 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 3, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)