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

Respiratory Insufficiency Clinical Trial

Official title:

Postoperative Utilization of Incentive Spirometry With and Without Electronic Patient Reminders in the Post-Anesthesia Care Unit (PACU)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304493
• Other study ID #: 23-2470
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Emily G Helmer
• Phone: 3037242938
• Email: emily.helmer[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypoxia
• Incentive Spirometry
• Patient Adherence
• Postoperative Atelectasis
• Postoperative Hypoxemia
• Postoperative Pneumonia
• Postoperative Pulmonary Complications
• Pulmonary Atelectasis
• Respiratory Insufficiency
• Respiratory Therapy

Intervention

Device:
• Alarms
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.

Locations

Country	Name	City	State
United States	CU Anschutz	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — 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. — View 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. — 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of IS breaths attempted in PACU	Rate of incentive spirometry breaths attempted by patients per hour for up to 3 hours during the PACU stay	PACU stay (up to 3 hours)
Secondary	Time to first adequate IS breath	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	PACU stay (up to 3 hours)
Secondary	Duration of postoperative O2 therapy	The total postoperative length of oxygen therapy use from the time the patient arrives to PACU to the end of their O2 therapy	Hospital stay (up to first 3 postoperative days)
Secondary	Presence of postoperative pulmonary complications	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	Hospital stay (up to first 3 postoperative days)
Secondary	Individual postoperative pulmonary complications	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	Hospital stay (up to first 3 postoperative days)
Secondary	Need for ICU Admission after PACU	The frequency of patients requiring ICU admission immediately after their PACU stay	Hospital stay (up to first 3 postoperative days)
Secondary	PACU Length of Stay	The length of stay in the PACU	PACU stay