Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula

NCT04782817 | Completed DMC

• 1 other identifier: 181117
• Study Type: interventional
• Target: 3,568
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cardiovascular Surgical Procedure; Intubation

Keywords

High-flow nasal cannula oxygen therapy; Reintubation

Outcome Measures

Primary Outcomes (1)

• Reintubation within 48 hours of extubation

  Reintubation within 48 hours of initial extubation after cardiac surgery

  48 hours

Secondary Outcomes (8)

• Reintubation within 72 hours of extubation

  72 hours

• Reintubation after cardiac surgery

  hospital discharge (usually 14 days)

• All cause mortality

  30 days post surgery

• Hospital length of stay

  8 days

• Intensive Care Unit length of stay

  3 days

Study Arms (2)

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.

Other: Recommendation for high flow nasal cannula oxygen therapy order set

Provider Choice Standard Care

ACTIVE COMPARATOR

Participants be assigned standard provider choice of standard care therapy physician order set.

Other: Provider choice standard care order set

Interventions

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.

High Flow Nasal Canula Oxygen Therapy

Provider choice standard care order set OTHER

Participants will receive order set with provider choice of standard care therapy.

Provider Choice Standard Care

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Undergoing cardiac surgery, defined as a documented surgical service of "cardiac surgery" in the electronic health record, performed in the main operating rooms at Vanderbilt University Medical Center
• Admitted to the cardiovascular intensive care unit postoperatively with an endotracheal tube in place and mechanically ventilated
• Surgery duration (documented time between "Anesthesia start" and "Anesthesia stop" in the EHR) of at least 180 minutes
• Received an order to be extubated by a treating provider o Patients who meet all other criteria but do not receive an order to extubate will be randomized but not enrolled

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (13)

• 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.

  PMID: 25802193 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.

  PMID: 27938887 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.

  PMID: 21036063 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.

  PMID: 29530778 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.

  PMID: 27121707 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.

  PMID: 20406513 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.

  PMID: 1412117 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.

  PMID: 25980660 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.

  PMID: 29186485 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.

  PMID: 21908497 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.

  PMID: 19846404 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.

  PMID: 27886577 BACKGROUND

• 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.

  PMID: 36428016 DERIVED

Study Officials

• Robert E Freundlich, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Biomedical Informatics

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: November 1, 2021
• Primary Completion: November 19, 2025
• Study Completion: April 14, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)