Reminder-enhanced Incentive Spirometry Evaluation (RISE)
26. August 2026 aktualisiert von: University of Colorado, Denver
Reminder-enhanced Incentive Spirometry Evaluation (RISE)
The purpose of this study is to test whether automatic reminders with a light and a soft sound help patients improve deep breathing exercises after surgery.
These breathing exercises are routinely done with the help of a plastic device that you attach to your mouth and you take a deep breath.
These exercises are routinely recommended after major surgery to improve the oxygen level in your blood and reduce other respiratory problems.
Studienübersicht
Detaillierte Beschreibung
The goal of this project is to evaluate whether automatic reminders increase incentive spirometry performance (IS) and reduce hypoxemia during the first three postoperative days after inpatient non-cardiac surgery in patients with a preoperative ARISCAT risk score ≥26.
This three-center pilot study will first test the effectiveness of automatic IS reminders, compared to no reminders, on the quality of performance for three postoperative days after inpatient non-cardiac surgery. Then we will estimate the effect size of IS reminders on postoperative hypoxemia and other complications.
Studientyp
Interventionell
Einschreibung (Geschätzt)
88
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Emily G Helmer, BA
- Telefonnummer: (303) 724-2938
- E-Mail: emily.helmer@cuanschutz.edu
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- ≥18 years
- Planned non-cardiac surgery under general anesthesia with at least one night of hospitalization expected
- Preoperative ARISCAT risk score ≥26
- Signed informed consent
Exclusion Criteria:
- Inability to perform IS due to refusal, cognitive impairment, neuromuscular weakness, anatomical, or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometer)
- Have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual IS reminders
- Are part of a vulnerable population (minors, pregnant, prisoners)
- Lack of informed consent
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Alarms ON
A soft buzz and blinking light emitted from the incentive spirometer base attachment (monitor) will go off every twenty minutes during waking hours after major surgery.
|
Alarms are turned ON.
The alarms include a dim light and soft buzz every twenty minutes during waking hours.
|
|
Kein Eingriff: Alarms OFF
The patient will be given an incentive spirometer with the base attachment (monitor).
No light or soft buzz will be emitted from the device.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Median IS breaths per hour
Zeitfenster: Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)
|
Median adequate IS breaths per hour within eligible hours of all patients in each reminder group
|
Post-Anesthesia Care Unit (PACU) admission to postoperative day 3 (POD3)
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hypoxemia
Zeitfenster: From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)
|
Hypoxemia will be calculated using the trapezoidal rule when PaO₂/FiO₂ < 300.
The total time with hypoxemia for each POD will be observed using the area-under-curve (AUC); i.e., the use of the area under the oxygen saturation curve
|
From post-anesthesia care unit (PACU) admission to postoperative day 3 (POD3)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Ana Fernandez-Bustamante, MD, PhD, University of Colorado, Denver
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- Canet 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.
- 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.
- 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.
- 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.
- 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.
- Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
- Peipert JD, Badawy SM, Baik SH, Oswald LB, Efficace F, Garcia SF, Mroczek DK, Wolf M, Kaiser K, Yanez B, Cella D. Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS). Patient Prefer Adherence. 2020 Jun 9;14:971-983. doi: 10.2147/PPA.S249079. eCollection 2020.
- Bender SP, Paganelli WC, Gerety LP, Tharp WG, Shanks AM, Housey M, Blank RS, Colquhoun DA, Fernandez-Bustamante A, Jameson LC, Kheterpal S. Intraoperative Lung-Protective Ventilation Trends and Practice Patterns: A Report from the Multicenter Perioperative Outcomes Group. Anesth Analg. 2015 Nov;121(5):1231-9. doi: 10.1213/ANE.0000000000000940.
- Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
- 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.
- Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB. PROMIS(R) Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains. Value Health. 2019 May;22(5):537-544. doi: 10.1016/j.jval.2019.02.004.
- Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.
- Stock MC, Downs JB, Gauer PK, Alster JM, Imrey PB. Prevention of postoperative pulmonary complications with CPAP, incentive spirometry, and conservative therapy. Chest. 1985 Feb;87(2):151-7. doi: 10.1378/chest.87.2.151.
- Bartels K, Fernandez-Bustamante A, McWilliams SK, Hopfer CJ, Mikulich-Gilbertson SK. Long-term opioid use after inpatient surgery - A retrospective cohort study. Drug Alcohol Depend. 2018 Jun 1;187:61-65. doi: 10.1016/j.drugalcdep.2018.02.013. Epub 2018 Mar 27.
- PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.
- Bartels K, Kaizer A, Jameson L, Bullard K, Dingmann C, Fernandez-Bustamante A. Hypoxemia Within the First 3 Postoperative Days Is Associated With Increased 1-Year Postoperative Mortality After Adjusting for Perioperative Opioids and Other Confounders. Anesth Analg. 2020 Aug;131(2):555-563. doi: 10.1213/ANE.0000000000004553.
- Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.
- Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216.
- 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.
- 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.
- Zorrilla-Vaca A, Grant MC, Urman RD, Frendl G. Individualised positive end-expiratory pressure in abdominal surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Nov;129(5):815-825. doi: 10.1016/j.bja.2022.07.009. Epub 2022 Aug 26.
- Fernandez-Bustamante A, Sprung J, Parker RA, Bartels K, Weingarten TN, Kosour C, Thompson BT, Vidal Melo MF. Individualized PEEP to optimise respiratory mechanics during abdominal surgery: a pilot randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):383-392. doi: 10.1016/j.bja.2020.06.030. Epub 2020 Jul 16.
- Fernandez-Bustamante A, Parker RA, Sprung J, Eikermann M, Gama de Abreu M, Ferrando C, Thompson BT, Vidal Melo MF. An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol. PLoS One. 2023 Apr 6;18(4):e0283748. doi: 10.1371/journal.pone.0283748. eCollection 2023.
- Blum JM, Stentz MJ, Dechert R, Jewell E, Engoren M, Rosenberg AL, Park PK. Preoperative and intraoperative predictors of postoperative acute respiratory distress syndrome in a general surgical population. Anesthesiology. 2013 Jan;118(1):19-29. doi: 10.1097/ALN.0b013e3182794975.
- 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.
- Oliver CM, Warnakulasuriya S, McGuckin D, Singleton G, Martin P, Santos C, Bedford J, Wagstaff D, Sahni A, Gilhooly D, Wilson J, Edwards K, Baumber R, Vindrola-Padros C, Dorey J, Leeman I, Boyd-Carson H, Vohra R, Singh P, Bedford M, Vallance A, Aresu G, Tucker O, Swart M, Mythen MG; PQIP project delivery team; Moonesinghe SR; PQIP collaborative. Delivery of drinking, eating and mobilising (DrEaMing) and its association with length of hospital stay after major noncardiac surgery: observational cohort study. Br J Anaesth. 2022 Jul;129(1):114-126. doi: 10.1016/j.bja.2022.03.021. Epub 2022 May 12.
- Grass F, Pache B, Martin D, Addor V, Hahnloser D, Demartines N, Hubner M. Feasibility of early postoperative mobilisation after colorectal surgery: A retrospective cohort study. Int J Surg. 2018 Aug;56:161-166. doi: 10.1016/j.ijsu.2018.06.024. Epub 2018 Jun 20.
- Schumann R, Kwater AP, Bonney I, Ladd D, Kim J, Gupta A, Gumbert SD, Pivalizza EG. Respiratory volume monitoring in an obese surgical population and the prediction of postoperative respiratory depression by the STOP-bang OSA risk score. J Clin Anesth. 2016 Nov;34:295-301. doi: 10.1016/j.jclinane.2016.04.029. Epub 2016 Jun 1.
- Ebert TJ, Middleton AH, Makhija N. Ventilation monitoring during moderate sedation in GI patients. J Clin Monit Comput. 2017 Feb;31(1):53-57. doi: 10.1007/s10877-015-9809-1. Epub 2015 Dec 1.
- van den Bosch OFC, Alvarez-Jimenez R, Stam MMH, den Boer FC, Loer SA. Variations in respiratory rate do not reflect changes in tidal volume or minute ventilation after major abdominal surgery. J Clin Monit Comput. 2021 Aug;35(4):787-796. doi: 10.1007/s10877-020-00538-3. Epub 2020 Jun 1.
- Odor PM, Bampoe S, Gilhooly D, Creagh-Brown B, Moonesinghe SR. Perioperative interventions for prevention of postoperative pulmonary complications: systematic review and meta-analysis. BMJ. 2020 Mar 11;368:m540. doi: 10.1136/bmj.m540.
- Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Wanderer JP, Ehrenfeld JM, Epstein RH, Kor DJ, Bartz RR, Fernandez-Bustamante A, Vidal Melo MF, Blum JM. Temporal trends and current practice patterns for intraoperative ventilation at U.S. academic medical centers: a retrospective study. BMC Anesthesiol. 2015 Mar 28;15:40. doi: 10.1186/s12871-015-0010-3. eCollection 2015.
- Brandao JC, Lessa MA, Motta-Ribeiro G, Hashimoto S, Paula LF, Torsani V, Le L, Bao X, Eikermann M, Dahl DM, Deng H, Tabatabaei S, Amato MBP, Vidal Melo MF. Global and Regional Respiratory Mechanics During Robotic-Assisted Laparoscopic Surgery: A Randomized Study. Anesth Analg. 2019 Dec;129(6):1564-1573. doi: 10.1213/ANE.0000000000004289.
- Blum JM, Maile M, Park PK, Morris M, Jewell E, Dechert R, Rosenberg AL. A description of intraoperative ventilator management in patients with acute lung injury and the use of lung protective ventilation strategies. Anesthesiology. 2011 Jul;115(1):75-82. doi: 10.1097/ALN.0b013e31821a8d63.
- Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.
- Eltorai 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.
- Ripolles-Melchor J, Ramirez-Rodriguez JM, Casans-Frances R, Aldecoa C, Abad-Motos A, Logrono-Egea M, Garcia-Erce JA, Camps-Cervantes A, Ferrando-Ortola C, Suarez de la Rica A, Cuellar-Martinez A, Marmana-Mezquita S, Abad-Gurumeta A, Calvo-Vecino JM; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (REDGERM). Association Between Use of Enhanced Recovery After Surgery Protocol and Postoperative Complications in Colorectal Surgery: The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study. JAMA Surg. 2019 Aug 1;154(8):725-736. doi: 10.1001/jamasurg.2019.0995.
- Sprung J, Whalley DG, Falcone T, Wilks W, Navratil JE, Bourke DL. The effects of tidal volume and respiratory rate on oxygenation and respiratory mechanics during laparoscopy in morbidly obese patients. Anesth Analg. 2003 Jul;97(1):268-74, table of contents. doi: 10.1213/01.ane.0000067409.33495.1f.
- Campbell MK, Grimshaw JM, Elbourne DR. Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported. BMC Med Res Methodol. 2004 Apr 28;4:9. doi: 10.1186/1471-2288-4-9.
- Brown SM, Duggal A, Hou PC, Tidswell M, Khan A, Exline M, Park PK, Schoenfeld DA, Liu M, Grissom CK, Moss M, Rice TW, Hough CL, Rivers E, Thompson BT, Brower RG; National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. Nonlinear Imputation of PaO2/FIO2 From SpO2/FIO2 Among Mechanically Ventilated Patients in the ICU: A Prospective, Observational Study. Crit Care Med. 2017 Aug;45(8):1317-1324. doi: 10.1097/CCM.0000000000002514.
- Li K, Saab R, Bravo M, Mascha EJ, Han Y, Nault R, Olson L, Sessler DI. Wearable device for prevention of postoperative and post-discharge hypoxemia: A randomized pilot trial. Acta Anaesthesiol Scand. 2023 Apr;67(4):440-447. doi: 10.1111/aas.14193. Epub 2023 Jan 13.
- Wang R, Haberlen SA, Palella FJ Jr, Mugavero MJ, Margolick JB, Macatangay BJC, Martinez-Maza O, Jacobson LP, Abraham AG. Viremia copy-years and mortality among combination antiretroviral therapy-initiating HIV-positive individuals: how much viral load history is enough? AIDS. 2018 Nov 13;32(17):2547-2556. doi: 10.1097/QAD.0000000000001986.
- Hall JC, Tarala R, Harris J, Tapper J, Christiansen K. Incentive spirometry versus routine chest physiotherapy for prevention of pulmonary complications after abdominal surgery. Lancet. 1991 Apr 20;337(8747):953-6. doi: 10.1016/0140-6736(91)91580-n.
- Mazzinari G, Serpa Neto A, Hemmes SNT, Hedenstierna G, Jaber S, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Pearse RM, Putensen C, Schmid W, Severgnini P, Wrigge H, Cambronero OD, Ball L, de Abreu MG, Pelosi P, Schultz MJ; LAS VEGAS study-investigators; PROtective VEntilation NETwork; Clinical Trial Network of the European Society of Anaesthesiology. The Association of Intraoperative driving pressure with postoperative pulmonary complications in open versus closed abdominal surgery patients - a posthoc propensity score-weighted cohort analysis of the LAS VEGAS study. BMC Anesthesiol. 2021 Mar 19;21(1):84. doi: 10.1186/s12871-021-01268-y.
- Ranjeva S, Nagebretsky A, Odozynski G, Fernandez-Bustamante A, Frendl G, Gupta RA, Sprung J, Subramaniam B, Ruiz RM, Bartels K, Giquel J, Lee JW, Houle T, Melo MFV. Effects of Intra-operative Cardiopulmonary Variability On Post-operative Pulmonary Complications in Major Non-cardiac Surgery: A Retrospective Cohort Study. J Med Syst. 2024 Mar 15;48(1):31. doi: 10.1007/s10916-024-02050-6.
- Bartels K, Frendl G, Sprung J, Weingarten TN, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Sodickson A, Giquel J, Vidal Melo MF, Fernandez-Bustamante A; Perioperative Research Network (PRN) investigators. Postoperative pulmonary complications with adjuvant regional anesthesia versus general anesthesia alone: a sub-analysis of the Perioperative Research Network study. BMC Anesthesiol. 2022 May 3;22(1):136. doi: 10.1186/s12871-022-01679-5.
- Celli BR, Rodriguez KS, Snider GL. A controlled trial of intermittent positive pressure breathing, incentive spirometry, and deep breathing exercises in preventing pulmonary complications after abdominal surgery. Am Rev Respir Dis. 1984 Jul;130(1):12-5. doi: 10.1164/arrd.1984.130.1.12.
- Zhao CH, Sun YH, Mao XM. Volume Incentive Spirometry Reduces Pulmonary Complications in Patients After Open Abdominal Surgery: A Randomized Clinical Trial. Int J Gen Med. 2023 Mar 1;16:793-801. doi: 10.2147/IJGM.S400030. eCollection 2023.
- Campos NS, Bluth T, Hemmes SNT, Librero J, Pozo N, Ferrando C, Ball L, Mazzinari G, Pelosi P, Gama de Abreu M, Schultz MJ, Serpa Neto A; REPEAT; investigators for the PROVHILO study; iPROVE study; PROBESE study investigators; PROVE Network. Intraoperative positive end-expiratory pressure and postoperative pulmonary complications: a patient-level meta-analysis of three randomised clinical trials. Br J Anaesth. 2022 Jun;128(6):1040-1051. doi: 10.1016/j.bja.2022.02.039. Epub 2022 Apr 15.
- Fernandez-Bustamante A, Parker RA, Frendl G, Lee JW, Nagrebetsky A, Grecu L, Amar D, Tanaka P, Sprung J, Gupta RA, Subramanian B, Giquel J, Eikermann M, Musch G, Nadler JW, Gama de Abreu M, Bartels K, Grover M, Chen LL, Sparling J, Douin DJ, Weingarten T, Wagener G, Thompson BT, Vidal Melo MF; Perioperative Research Network (PRN) Investigators. Perioperative lung expansion and pulmonary outcomes after open abdominal surgery versus usual care in the USA (PRIME-AIR): a multicentre, randomised, controlled, phase 3 trial. Lancet Respir Med. 2025 May;13(5):447-459. doi: 10.1016/S2213-2600(25)00040-2. Epub 2025 Feb 25.
- Eltorai AEM, Baird GL, Pangborn J, Eltorai AS, Antoci V Jr, Paquette K, Connors K, Barbaria J, Smeals KJ, Riley B, Patel SA, Agarwal S, Healey TT, Ventetuolo CE, Sellke FW, Daniels AH. Financial Impact of Incentive Spirometry. Inquiry. 2018 Jan-Dec;55:46958018794993. doi: 10.1177/0046958018794993.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. November 2026
Primärer Abschluss (Geschätzt)
31. Oktober 2028
Studienabschluss (Geschätzt)
1. Januar 2029
Studienanmeldedaten
Zuerst eingereicht
22. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Juli 2026
Zuerst gepostet (Tatsächlich)
27. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
31. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. August 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 26-1508
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Patient privacy protection
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Ja
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .