Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
The iCAN trial is a pragmatic randomized controlled trial that aims to test the hypothesis that HFNC versus usual care oxygenation strategies applied immediately after initial extubation after cardiac surgery decreases the all-cause 48-hour reintubation rate (extubation failure within 48 hours of initial extubation).
HFNC may be employed as a strategy to facilitate early extubation and prevent reintubation of patients following cardiac surgery. HFNC is routinely employed by providers in the cardiovascular intensive care unit along with other therapies, including: bi-level positive airway pressure, non-rebreather masks, among others. Currently, no high-quality clinical data exist to demonstrate that HFNC may decrease the risk of reintubation in this critically-ill adult population.
This prospective, randomized, pragmatic clinical trial will compare HFNC to provider choice of usual care in these high-risk patients.
Randomization will occur at the time that the patient is deemed ready for extubation by the attending physician in the cardiovascular intensive care unit. Through randomization, patients will be assigned one of two physician order sets in the electronic medical record system: standard order set with or without recommendation for the use of HFNC. Reintubation and outcome data will be collected until patient discharge.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Nasal Canula Oxygen Therapy | Experimental | Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates. |
|
| Provider Choice Standard Care | Active Comparator | Participants be assigned standard provider choice of standard care therapy physician order set. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recommendation for high flow nasal cannula oxygen therapy order set | Other | Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates. |
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation within 48 hours of extubation | Reintubation within 48 hours of initial extubation after cardiac surgery | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation within 72 hours of extubation | Reintubation within 72 hours of initial extubation after cardiac surgery | 72 hours |
| Reintubation after cardiac surgery | Reintubation at any time during hospitalization after cardiac surgery |
Not provided
Inclusion Criteria
Exclusion Criteria
• Patient does not meet inclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert E Freundlich, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25802193 | Background | Khandelwal N, Dale CR, Benkeser DC, Joffe AM, Yanez ND 3rd, Treggiari MM. Variation in tracheal reintubations among patients undergoing cardiac surgery across Washington state hospitals. J Cardiothorac Vasc Anesth. 2015;29(3):551-9. doi: 10.1053/j.jvca.2014.11.009. Epub 2014 Nov 11. | |
| 27938887 | Background | Freundlich RE, Maile MD, Hajjar MM, Habib JR, Jewell ES, Schwann T, Habib RH, Engoren M. Years of Life Lost After Complications of Coronary Artery Bypass Operations. Ann Thorac Surg. 2017 Jun;103(6):1893-1899. doi: 10.1016/j.athoracsur.2016.09.048. Epub 2016 Dec 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2026 | Feb 25, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Provider choice standard care order set | Other | Participants will receive order set with provider choice of standard care therapy. |
|
| hospital discharge (usually 14 days) |
| All cause mortality | 30 days post surgery |
| Hospital length of stay | 8 days |
| Intensive Care Unit length of stay | Intensive Care Unit length of stay after cardiac surgery | 3 days |
| Ventilator-free days | Ventilator-free days during hospitalization after cardiac surgery | 1 day |
| In-hospital mortality | Mortality which occurs in-hospital following surgery, up to the time of hospital discharge | Until hospital discharge, which usually occurs in approximately 8 days in the majority of patients |
| Adjusted reintubation rate | Adjusted reintubation rate within 48 hours of initial extubation, if adjustment is needed based on clinically relevant imbalance in baseline characteristics between groups | 48 hours |
| 21036063 | Background | Dorsa AG, Rossi AI, Thierer J, Lupianez B, Vrancic JM, Vaccarino GN, Piccinini F, Raich H, Bonazzi SV, Benzadon M, Navia DO. Immediate extubation after off-pump coronary artery bypass graft surgery in 1,196 consecutive patients: feasibility, safety and predictors of when not to attempt it. J Cardiothorac Vasc Anesth. 2011 Jun;25(3):431-6. doi: 10.1053/j.jvca.2010.08.013. Epub 2010 Oct 29. |
| 29530778 | Background | Chan JL, Miller JG, Murphy M, Greenberg A, Iraola M, Horvath KA. A Multidisciplinary Protocol-Driven Approach to Improve Extubation Times After Cardiac Surgery. Ann Thorac Surg. 2018 Jun;105(6):1684-1690. doi: 10.1016/j.athoracsur.2018.02.008. Epub 2018 Mar 9. |
| 27121707 | Background | Roca O, Hernandez G, Diaz-Lobato S, Carratala JM, Gutierrez RM, Masclans JR; Spanish Multidisciplinary Group of High Flow Supportive Therapy in Adults (HiSpaFlow). Current evidence for the effectiveness of heated and humidified high flow nasal cannula supportive therapy in adult patients with respiratory failure. Crit Care. 2016 Apr 28;20(1):109. doi: 10.1186/s13054-016-1263-z. |
| 20406513 | Background | Markovitz GH, Colthurst J, Storer TW, Cooper CB. Effective inspired oxygen concentration measured via transtracheal and oral gas analysis. Respir Care. 2010 Apr;55(4):453-9. |
| 1412117 | Background | Bazuaye EA, Stone TN, Corris PA, Gibson GJ. Variability of inspired oxygen concentration with nasal cannulas. Thorax. 1992 Aug;47(8):609-11. doi: 10.1136/thx.47.8.609. |
| 25980660 | Background | Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213. |
| 29186485 | Background | Masip J, Peacock WF, Price S, Cullen L, Martin-Sanchez FJ, Seferovic P, Maisel AS, Miro O, Filippatos G, Vrints C, Christ M, Cowie M, Platz E, McMurray J, DiSomma S, Zeymer U, Bueno H, Gale CP, Lettino M, Tavares M, Ruschitzka F, Mebazaa A, Harjola VP, Mueller C; Acute Heart Failure Study Group of the Acute Cardiovascular Care Association and the Committee on Acute Heart Failure of the Heart Failure Association of the European Society of Cardiology. Indications and practical approach to non-invasive ventilation in acute heart failure. Eur Heart J. 2018 Jan 1;39(1):17-25. doi: 10.1093/eurheartj/ehx580. |
| 21908497 | Background | Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9. |
| 19846404 | Background | Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20. |
| 27886577 | Background | Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy vs conventional oxygen therapy in cardiac surgical patients: A meta-analysis. J Crit Care. 2017 Apr;38:123-128. doi: 10.1016/j.jcrc.2016.10.027. Epub 2016 Nov 9. |
| 36428016 | Derived | Freundlich RE, Wanderer JP, French B, Moore RP, Hernandez A, Shah AS, Byrne DW, Pandharipande PP. Protocol for a randomised controlled trial: reducing reintubation among high-risk cardiac surgery patients with high-flow nasal cannula (I-CAN). BMJ Open. 2022 Nov 25;12(11):e066007. doi: 10.1136/bmjopen-2022-066007. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2025 | Feb 25, 2026 | SAP_001.pdf |