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| ID | Type | Description | Link |
|---|---|---|---|
| HenanICE201601 | Registry Identifier | HenanICE201601 |
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The investigators hypothesized that heated humidified high-flow nasal cannula oxygen(HFNC) along with high quality of sleep, in comparison with noninvasive positive pressure ventilation (NIV), could reduce the release of inflammatory marker C-reactive protein(CRP), which as independent predictor of atrial fibrillation（AF）, further lower the incidence of new-onset AF following coronary artery bypass grafting(CABG).
Atrial fibrillation (AF) has been reported to occur in up to 20-40% of patients undergoing coronary artery bypass grafting (CABG). Postoperative AF plays a major role in the determination of hemodynamic deterioration and can be associated with thromboembolic stroke. Aside from the risk factors of age, pain, cardiac dysfunction and hypokalemia, hypoxemia is also considered to be the major contributor to AF initiation and persistence. Aiming to the common postoperative complications, noninvasive positive pressure ventilation (NIV) provides an available modality to improve the oxygen and even obviate the reintubation.
However, some patients are contraindications for NIV, with Loss of consciousness, hemodynamic instability, and some are intolerance due to dryness, gastric distension, skin breakdown and noise, with complaints of insomnia and sleep disturbance. The aforementioned factors largely limits its use. Recently, the heated humidified high-flow nasal cannula (HFNC), free of psychic stress and physical discomfort, shows a favorable compliance and tolerance in treating the hypoxemic patients. As a result, in this comfortable setting we predict a high sleep quality in HFNC oxygen therapy. Evidence has suggested that sleep abnormalities trigger the cascaded release of C-reactive protein (CRP). As is well known that CRP is involved in atrial structural remodeling and asynchronous conduction, which attribute to the initiation and maintenance of AF.
Therefore, in this present study, the investigators first evaluate the sleep quality (architecture and duration) by the polysomnographic (PSG) monitoring after coronary surgery. Based on the sleep parameters, the investigators hypothesize that HFNC, along with high quality of sleep, in comparison with NIV, could reduce the release of C-reactive protein, which as independent predictor of atrial fibrillation (AF), further lower the incidence of new-onset AF following CABG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFNC group | Experimental | HFNC: Heated humidified high-flow nasal cannula. |
|
| NIV group | Active Comparator | NIV: Noninvasive ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heated humidified high-flow nasal cannula | Device | HFNC device (Airvo™, Fisher＆Paykel, Auckland, New Zealand) with a heated circuit (Fisher＆Paykel,900PT501) and nasal cannula(optiflow TM,Fisher＆Paykel). It has adjustable FiO2: 21%-100%, gas flow up to 60 L/min, to maintain arterial blood hemoglobin oxygen saturation ( SPO2) > 92%. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of atrial fibrillation | from ICU admission to discharge | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| PO2/FiO2(P/F) | from ICU admission to discharge | 5 days |
| Lactate levels | from ICU admission to discharge | 5 days |
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Inclusion criteria:
Hypoxemic respiratory failure
Exclusion criteria:
Cardiac or respiratory arrest
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| You Zhang, MD | Contact | 13598019682 | 037165580759 | 13598019682@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoyun Cheng, MD | Henan Provincial People' Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People' Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14975482 | Background | Meier-Ewert HK, Ridker PM, Rifai N, Regan MM, Price NJ, Dinges DF, Mullington JM. Effect of sleep loss on C-reactive protein, an inflammatory marker of cardiovascular risk. J Am Coll Cardiol. 2004 Feb 18;43(4):678-83. doi: 10.1016/j.jacc.2003.07.050. | |
| 19294365 | Background | Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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|
| noninvasive ventilation | Device | TBird VELA ventilator, CareFusion, USA. Pressure adjustments were to optimize patient comfort. Inspiratory pressure was raised every 5 mins until comfort was optimized. FiO2 was adjusted to maintain SPO2 > 92%. |
|
|
| intubation time | from intubation in the operating room to discharge | 5 days |
| transfusion requirement | from ICU admission to discharge | 5 days |
| inotropic usage | from ICU admission to discharge | 5 days |
| total sleep time | The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery. | 48 hours |
| rapid eye movement (REM) sleep (%) | The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery. | 48 hours |
| arousal index | The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery. | 48 hours |
| 17597037 | Background | Ucar HI, Tok M, Atalar E, Dogan OF, Oc M, Farsak B, Guvener M, Yilmaz M, Dogan R, Demircin M, Pasaoglu I. Predictive significance of plasma levels of interleukin-6 and high-sensitivity C-reactive protein in atrial fibrillation after coronary artery bypass surgery. Heart Surg Forum. 2007;10(2):E131-5. doi: 10.1532/HSF98.20061175. |
| 22417569 | Background | Cuquemelle E, Pham T, Papon JF, Louis B, Danin PE, Brochard L. Heated and humidified high-flow oxygen therapy reduces discomfort during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1571-7. doi: 10.4187/respcare.01681. Epub 2012 Mar 12. |
| 24973105 | Background | Elliott R, Rai T, McKinley S. Factors affecting sleep in the critically ill: an observational study. J Crit Care. 2014 Oct;29(5):859-63. doi: 10.1016/j.jcrc.2014.05.015. Epub 2014 May 29. |
| 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. |
| 17433956 | Result | Liu T, Li G, Li L, Korantzopoulos P. Association between C-reactive protein and recurrence of atrial fibrillation after successful electrical cardioversion: a meta-analysis. J Am Coll Cardiol. 2007 Apr 17;49(15):1642-1648. doi: 10.1016/j.jacc.2006.12.042. Epub 2007 Apr 2. |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |