- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02713737
The Correlation Between Sleep Quality and Atrial Fibrillation Undergoing High-flow Nasal Cannula Oxygen (HFNC)
Impact of High-flow Nasal Cannula Oxygen (HFNC) Versus Noninvasive Ventilation Associated With Sleep Quality on Atrial Fibrillation in Hypoxemic Patients After Coronary Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: You Zhang, MD
- Phone Number: 037165580759 13598019682
- Email: 13598019682@126.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450003
- Recruiting
- Henan Provincial People' Hospital
-
Contact:
- You Zhang, MD
- Phone Number: 037165580759 13598019682
- Email: 13598019682@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
Hypoxemic respiratory failure
Exclusion criteria:
Cardiac or respiratory arrest
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HFNC group
HFNC: Heated humidified high-flow nasal cannula.
|
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%.
|
Active Comparator: NIV group
NIV: Noninvasive ventilation.
|
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%.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of atrial fibrillation
Time Frame: 10 days
|
from ICU admission to discharge
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PO2/FiO2(P/F)
Time Frame: 5 days
|
from ICU admission to discharge
|
5 days
|
Lactate levels
Time Frame: 5 days
|
from ICU admission to discharge
|
5 days
|
intubation time
Time Frame: 5 days
|
from intubation in the operating room to discharge
|
5 days
|
transfusion requirement
Time Frame: 5 days
|
from ICU admission to discharge
|
5 days
|
inotropic usage
Time Frame: 5 days
|
from ICU admission to discharge
|
5 days
|
total sleep time
Time Frame: 48 hours
|
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 (%)
Time Frame: 48 hours
|
The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
|
48 hours
|
arousal index
Time Frame: 48 hours
|
The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
|
48 hours
|
Collaborators and Investigators
Investigators
- Study Director: Zhaoyun Cheng, MD, Henan Provincial People' Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HenanICE
- HenanICE201601 (Registry Identifier: HenanICE201601)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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