The Correlation Between Sleep Quality and Atrial Fibrillation Undergoing High-flow Nasal Cannula Oxygen (HFNC)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Impact of High-flow Nasal Cannula Oxygen (HFNC) Versus Noninvasive Ventilation Associated With Sleep Quality on Atrial Fibrillation in Hypoxemic Patients After Coronary Surgery

Conditions
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Hypoxemia

Intervention / Treatment
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* Device: heated humidified high-flow nasal cannula
* Device: noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Hypoxemic respiratory failure Exclusion criteria: Cardiac or respiratory arrest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNC group<br>HFNC: Heated humidified high-flow nasal cannula. | Device: heated humidified high-flow nasal cannula<br>* 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%.<br>|
| Active Comparator: NIV group<br>NIV: Noninvasive ventilation. | Device: noninvasive ventilation<br>* 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%.<br>* Other names: noninvasive positive pressure ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of atrial fibrillation | from ICU admission to discharge | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PO2/FiO2(P/F) | from ICU admission to discharge | 5 days | 
| Lactate levels | from ICU admission to discharge | 5 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoxemia, high-flow, atrial fibrillation, sleep