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

Hypoxemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02713737
• Other study ID #: HenanICE
• Secondary ID: HenanICE201601
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: April 2023

Study information

• Verified date: March 2021
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: You Zhang, MD
• Phone: 13598019682
• Email: 13598019682[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Hypoxemic respiratory failure

Exclusion criteria:

Cardiac or respiratory arrest

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypoxemia
• Hypoxia

Intervention

Device:
• 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%.
• 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%.

Locations

Country	Name	City	State
China	Henan Provincial People' Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. Epub 2012 Mar 12. — View 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. — View 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. — View 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. — View Citation

Stéphan F, Barrucand B, Petit P, Rézaiguia-Delclaux S, Médard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Bérard 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of atrial fibrillation	from ICU admission to discharge	10 days
Secondary	PO2/FiO2(P/F)	from ICU admission to discharge	5 days
Secondary	Lactate levels	from ICU admission to discharge	5 days
Secondary	intubation time	from intubation in the operating room to discharge	5 days
Secondary	transfusion requirement	from ICU admission to discharge	5 days
Secondary	inotropic usage	from ICU admission to discharge	5 days
Secondary	total sleep time	The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.	48 hours
Secondary	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
Secondary	arousal index	The duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.	48 hours