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

NCT02713737 | Unknown Phase 4

• 2 other identifiers: HenanICEHenanICE201601
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypoxemia

Keywords

hypoxemia; high-flow; atrial fibrillation; sleep

Outcome Measures

Primary Outcomes (1)

• Incidence of atrial fibrillation

  from ICU admission to discharge

  10 days

Secondary Outcomes (8)

• PO2/FiO2(P/F)

  5 days

• Lactate levels

  5 days

• intubation time

  5 days

• transfusion requirement

  5 days

• inotropic usage

  5 days

Study Arms (2)

HFNC group

EXPERIMENTAL

HFNC: Heated humidified high-flow nasal cannula.

Device: heated humidified high-flow nasal cannula

NIV group

ACTIVE COMPARATOR

NIV: Noninvasive ventilation.

Device: noninvasive ventilation

Interventions

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%.

HFNC group

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%.

Also known as: noninvasive positive pressure ventilation

NIV group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypoxemic respiratory failure

You may not qualify if:

• Cardiac or respiratory arrest

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Henan Provincial People' Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 14975482 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.

  PMID: 19294365 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.

  PMID: 17597037 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.

  PMID: 22417569 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.

  PMID: 24973105 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.

  PMID: 25980660 BACKGROUND

• 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.

  PMID: 17433956 RESULT

MeSH Terms

Conditions

Hypoxia; Atrial Fibrillation

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Zhaoyun Cheng, MD

  Henan Provincial People' Hospital

  STUDY DIRECTOR

Central Study Contacts

You Zhang, MD

CONTACT

13598019682; 13598019682@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 21, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)