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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02713737
Enrollment
80
Registered
2016-03-21
Start date
2016-04-30
Completion date
2023-04-30
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia

Keywords

hypoxemia, high-flow, atrial fibrillation, sleep

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.

Interventions

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%.

DEVICEnoninvasive 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%.

Sponsors

Henan Institute of Cardiovascular Epidemiology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Hypoxemic respiratory failure

Exclusion criteria

Cardiac or respiratory arrest

Design outcomes

Primary

MeasureTime frameDescription
Incidence of atrial fibrillation10 daysfrom ICU admission to discharge

Secondary

MeasureTime frameDescription
Lactate levels5 daysfrom ICU admission to discharge
intubation time5 daysfrom intubation in the operating room to discharge
transfusion requirement5 daysfrom ICU admission to discharge
PO2/FiO2(P/F)5 daysfrom ICU admission to discharge
total sleep time48 hoursThe duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
rapid eye movement (REM) sleep (%)48 hoursThe duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
arousal index48 hoursThe duration from 8 in the evening to 8 in the morning within the first 2 days after surgery.
inotropic usage5 daysfrom ICU admission to discharge

Countries

China

Contacts

Primary ContactYou Zhang, MD
13598019682@126.com13598019682

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026