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Clinical Trials/NCT02713737
NCT02713737
Unknown
Phase 4

Impact of High-flow Nasal Cannula Oxygen (HFNC) Versus Noninvasive Ventilation Associated With Sleep Quality on Atrial Fibrillation in Hypoxemic Patients After Coronary Surgery

Henan Institute of Cardiovascular Epidemiology1 site in 1 country80 target enrollmentApril 2016
ConditionsHypoxemia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Hypoxemia
Sponsor
Henan Institute of Cardiovascular Epidemiology
Enrollment
80
Locations
1
Primary Endpoint
Incidence of atrial fibrillation
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
April 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Henan Institute of Cardiovascular Epidemiology
Responsible Party
Principal Investigator
Principal Investigator

Jian Zhao

associate professor

Henan Institute of Cardiovascular Epidemiology

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of atrial fibrillation

Time Frame: 10 days

from ICU admission to discharge

Secondary Outcomes

  • inotropic usage(5 days)
  • rapid eye movement (REM) sleep (%)(48 hours)
  • PO2/FiO2(P/F)(5 days)
  • Lactate levels(5 days)
  • intubation time(5 days)
  • transfusion requirement(5 days)
  • total sleep time(48 hours)
  • arousal index(48 hours)

Study Sites (1)

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