The Correlation Between Sleep Quality and Atrial Fibrillation Undergoing High-flow Nasal Cannula Oxygen (HFNC)
Primary Purpose
Hypoxemia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
heated humidified high-flow nasal cannula
noninvasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxemia focused on measuring hypoxemia, high-flow, atrial fibrillation, sleep
Eligibility Criteria
Inclusion criteria:
Hypoxemic respiratory failure
Exclusion criteria:
Cardiac or respiratory arrest
Sites / Locations
- Henan Provincial People' HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HFNC group
NIV group
Arm Description
HFNC: Heated humidified high-flow nasal cannula.
NIV: Noninvasive ventilation.
Outcomes
Primary Outcome Measures
Incidence of atrial fibrillation
from ICU admission to discharge
Secondary Outcome Measures
PO2/FiO2(P/F)
from ICU admission to discharge
Lactate levels
from ICU admission to discharge
intubation time
from intubation in the operating room to discharge
transfusion requirement
from ICU admission to discharge
inotropic usage
from ICU admission to discharge
total sleep time
The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
rapid eye movement (REM) sleep (%)
The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
arousal index
The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
Full Information
NCT ID
NCT02713737
First Posted
February 25, 2016
Last Updated
March 6, 2021
Sponsor
Henan Institute of Cardiovascular Epidemiology
1. Study Identification
Unique Protocol Identification Number
NCT02713737
Brief Title
The Correlation Between Sleep Quality and Atrial Fibrillation Undergoing High-flow Nasal Cannula Oxygen (HFNC)
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Institute of Cardiovascular Epidemiology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
Keywords
hypoxemia, high-flow, atrial fibrillation, sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFNC group
Arm Type
Experimental
Arm Description
HFNC: Heated humidified high-flow nasal cannula.
Arm Title
NIV group
Arm Type
Active Comparator
Arm Description
NIV: Noninvasive ventilation.
Intervention Type
Device
Intervention Name(s)
heated humidified high-flow nasal cannula
Intervention Description
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%.
Intervention Type
Device
Intervention Name(s)
noninvasive ventilation
Other Intervention Name(s)
noninvasive positive pressure ventilation
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Incidence of atrial fibrillation
Description
from ICU admission to discharge
Time Frame
10 days
Secondary Outcome Measure Information:
Title
PO2/FiO2(P/F)
Description
from ICU admission to discharge
Time Frame
5 days
Title
Lactate levels
Description
from ICU admission to discharge
Time Frame
5 days
Title
intubation time
Description
from intubation in the operating room to discharge
Time Frame
5 days
Title
transfusion requirement
Description
from ICU admission to discharge
Time Frame
5 days
Title
inotropic usage
Description
from ICU admission to discharge
Time Frame
5 days
Title
total sleep time
Description
The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
Time Frame
48 hours
Title
rapid eye movement (REM) sleep (%)
Description
The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
Time Frame
48 hours
Title
arousal index
Description
The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Hypoxemic respiratory failure
Exclusion criteria:
Cardiac or respiratory arrest
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
You Zhang, MD
Phone
13598019682
Ext
037165580759
Email
13598019682@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoyun Cheng, MD
Organizational Affiliation
Henan Provincial People' Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henan Provincial People' Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
You Zhang, MD
Phone
13598019682
Ext
037165580759
Email
13598019682@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
14975482
Citation
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.
Results Reference
background
PubMed Identifier
19294365
Citation
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.
Results Reference
background
PubMed Identifier
17597037
Citation
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.
Results Reference
background
PubMed Identifier
22417569
Citation
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.
Results Reference
background
PubMed Identifier
24973105
Citation
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.
Results Reference
background
PubMed Identifier
25980660
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.
Results Reference
background
PubMed Identifier
17433956
Citation
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.
Results Reference
result
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The Correlation Between Sleep Quality and Atrial Fibrillation Undergoing High-flow Nasal Cannula Oxygen (HFNC)
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