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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04782817
• Other study ID #: 181117
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: Robert E Freundlich, MD
• Phone: (615)936-6608
• Email: robert.e.freundlich[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare reintubation rates and outcomes of patients treated with high-flow nasal canula oxygen therapy (HFNC) and patients treated with provider choice of standard care.

Description:

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 and is selectively employed in patients who are judged by the provider to be high-risk, along with other therapies: 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.

To guide a future, larger, multicenter randomized controlled pragmatic clinical trial, a pilot study in a single, high-volume cardiovascular intensive care unit will be performed. The prospective, randomized, pragmatic pilot clinical trial will compare HFNC to provider choice of standard 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3192
• Est. completion date: December 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18 and over treated in the Vanderbilt Cardiovascular Intensive Care Unit following cardiac surgery (defined as surgery on the heart or thoracic aorta, excluding percutaneous procedures)

• Surgical duration (anesthesia start to anesthesia stop) of at least 3 hours.

• Intubated at the time of arrival in the Cardiovascular Intensive Care Unit

• Extubated to occur at some point following arrival in the Cardiovascular Intensive Care Unit with an order to extubate the patient by a treating provider.

Exclusion Criteria:

• Does not meet inclusion criteria

Related Conditions & MeSH terms

• Cardiovascular Surgical Procedure
• Intubation

Intervention

Other:
• Recommendation for high flow nasal cannula oxygen therapy order set
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 order set
Participants will receive order set with provider choice of standard care therapy.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reintubation within 48 hours of extubation	Reintubation within 48 hours of initial extubation after cardiac surgery	48 hours
Secondary	Reintubation within 72 hours of extubation	Reintubation within 72 hours of initial extubation after cardiac surgery	72 hours
Secondary	Reintubation after cardiac surgery	Reintubation at any time during hospitalization after cardiac surgery	hospital discharge (usually 14 days)
Secondary	In-hospital mortality	In-hospital mortality during hospitalization after cardiac surgery	hospital discharge (usually 14 days)
Secondary	All cause mortality		30 days post surgery
Secondary	Hospital length of stay		8 days
Secondary	Intensive Care Unit length of stay	Intensive Care Unit length of stay after cardiac surgery	3 days
Secondary	Ventilator-free days	Ventilator-free days during hospitalization after cardiac surgery	1 day