To test the effect and incidence of hypoxemia when oxygen supplementation through HFNC as compared to LFNC in patients with atrial fibrillation undergoing point-by-point ablation (like RFCA or Galaxy PFA) and deep sedation.
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Health condition
Oxygenatie tijdens diepe sedatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lowest saturation is the measured and main outcome.
Secondary outcome
Secondary objectives of the study are the duration of the lowest SpO2,
incidence of cross over, incidence of desaturation, adverse sedation events,
peak transcutaneous carbon dioxide (TcCO2), mean TcCO2, satisfaction of
patients with sedation, patients comfort with oxygen delivery, rating of
clinician of the anaesthesiology department of difficulty maintaining
oxygenation status, rating of clinician anaesthesiology of user-friendliness of
the oxygen delivery device and satisfaction of cardiologists with catheter
stability in relation to sedation.
Background summary
Oxygen supplementation through high flow nasal cannula (HFNC) may reduce the
incidence of desaturation and hypoxemia during deep sedation at radiofrequency
catheter ablation (RFCA procedures).This study is designed to test the
hypothesis that the incidence of hypoxemia and desaturation in patients with
atrial fibrillation undergoing point-by-point ablation (like RFCA or Galaxy
PFA) under deep sedation, is less when using HFNC as compared to use of
standard low flow nasal cannula (LFNC).
Study objective
To test the effect and incidence of hypoxemia when oxygen supplementation
through HFNC as compared to LFNC in patients with atrial fibrillation
undergoing point-by-point ablation (like RFCA or Galaxy PFA) and deep sedation.
Study design
A randomized controlled trial design is used. Patients will be randomized in a
1:1 ratio to oxygen supplementation through high flow nasal cannula (HFNC)
versus standard low flow nasal cannula (LFNC).
Intervention
One group receives HFNC and the other group receives LFNC.
Study burden and risks
The risk to and the burden for the subject is in proportion. LFNC as well HFNC
are both used in usual care. The use of HFNC may reduce the incidence of
hypoxemia during deep sedation at RFCA procedures. The nasal oxygen canula may
cause some discomfort. In addition, a nosebleed can occur, but this is rare.
The participant will fill out two questionnaires: Iowa Satisfaction with
Anaesthesia Scale (ISAS) and Likert scale on patients comfort with oxygen
delivery. The intervention and questionnaires take place during the hospital
admission for the RFCA or Galaxy PFA treatment. No other tests or additional
site visits are planned.
P.Debeyelaan 25
Maastricht 6229HX
NL
P.Debeyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Adults undergoing elective RFCA or Galaxy PFAfor atrial fibrillation in the
Maastricht UMC Cardiac Catheter Labs under deep sedation administrated by a
clinician anesthesiology.
Exclusion criteria
Age under 18 years
Body Mass Index > 32
Diagnosed sleep apnoea syndrome
Chronic pulmonary obstructive disease gold IV and COPD gold III with recent or
frequent exacerbation
Diagnosed pulmonary or cardiac condition requiring chronic oxygen therapy
Complete nasale obstruction
Active nose bleeding
Untreated pneumothorax (pre- existing)
Recent upper airway surgery
Recent base of skull fracture
Expected difficult airway.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72859.068.20 |