Back to resultsPrevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea (PAFOS)
Primary Purpose
Atrial Fibrillation, Obstructive Sleep Apnea, Coronary Artery Bypass Grafting
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- apnea-hypopnea index > 15 events/hour
Exclusion Criteria:
- ejection fraction < 45%
- chronic atrial fibrillation
- periprocedural instability (haemodynamic, neurological)
Sites / Locations
- Instituto de Medicina Integral Prof Fernando Figueira - Imip
- Pronto Socorro Cardiológico de Pernambuco - Procape
- INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CPAP group
Control Group
Arm Description
patients will receive CPAP therapy for the first 7 days after extubation from CABG
Patients will receive usal care
Outcomes
Primary Outcome Measures
atrial fibrillation
will be verified by holter monitoring
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02737215
Brief Title
Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea
Acronym
PAFOS
Official Title
Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea: a Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rodrigo Pinto Pedrosa
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Obstructive Sleep Apnea, Coronary Artery Bypass Grafting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP group
Arm Type
Active Comparator
Arm Description
patients will receive CPAP therapy for the first 7 days after extubation from CABG
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients will receive usal care
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
patients will receive CPAP therapy with Auto-CPAP
Primary Outcome Measure Information:
Title
atrial fibrillation
Description
will be verified by holter monitoring
Time Frame
first 7 days after CABG
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
apnea-hypopnea index > 15 events/hour
Exclusion Criteria:
ejection fraction < 45%
chronic atrial fibrillation
periprocedural instability (haemodynamic, neurological)
Facility Information:
Facility Name
Instituto de Medicina Integral Prof Fernando Figueira - Imip
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-550
Country
Brazil
Facility Name
Pronto Socorro Cardiológico de Pernambuco - Procape
City
Recife
State/Province
PE
ZIP/Postal Code
50.100-060
Country
Brazil
Facility Name
INCOR - Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35549838
Citation
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.
Results Reference
derived
Learn more about this trial
Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea
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