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Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea

NCT ID: NCT02737215

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-02

Study Completion Date

2019-12-31

Brief Summary

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Background. Atrial fibrillation is one of the most common complications in the postoperative period of coronary artery bypass grafting (CABG) surgery and usually associated with increased length of hospital stay and higher hospital costs. Among the main mechanisms involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental elements in the pathophysiology of obstructive sleep apnea. Objectives. To evaluate the effects of continuous positive airway pressure (CPAP) in reduction of atrial fibrillation after CABG in patients with obstructive sleep apnea. Methodological procedures: A multicenter randomized controlled study to compare the incidence of atrial fibrillation between the intervention group and the control group, both monitored seven days with Holter.

Detailed Description

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Conditions

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Atrial Fibrillation Obstructive Sleep Apnea Coronary Artery Bypass Grafting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP group

patients will receive CPAP therapy for the first 7 days after extubation from CABG

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

patients will receive CPAP therapy with Auto-CPAP

Control Group

Patients will receive usal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP

patients will receive CPAP therapy with Auto-CPAP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* apnea-hypopnea index \> 15 events/hour

Exclusion Criteria

* ejection fraction \< 45%
* chronic atrial fibrillation
* periprocedural instability (haemodynamic, neurological)
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rodrigo Pinto Pedrosa

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Pinto Pedrosa

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Pronto Socorro Cardiológico de Pernambuco - Procape

Recife, Pernambuco, Brazil

Site Status

Instituto de Medicina Integral Prof Fernando Figueira - Imip

Recife, Pernambuco, Brazil

Site Status

INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Chalegre ST, Barros MM, Silva BPG, Furlan SF, Giampa SQC, Marques JN, Albuquerque ALT, Monteiro VS, Drager LF, Pedrosa RP. Impact of Continuous Positive Airway Pressure on Postoperative Atrial Fibrillation in Patients with Obstructive Sleep Apnea Undergoing Coronary Artery Bypass Graft Surgery: An Exploratory Randomized Multicenter Study. Am J Respir Crit Care Med. 2022 Aug 1;206(3):358-360. doi: 10.1164/rccm.202112-2669LE. No abstract available.

Reference Type DERIVED
PMID: 35549838 (View on PubMed)

Other Identifiers

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PAFOS01

Identifier Type: -

Identifier Source: org_study_id