No registrations found.
ID
Source
Brief title
Health condition
Atrial fibrillation
Sponsors and support
Intervention
Outcome measures
Primary outcome
the effects of prolonged deep PSA on the arterial CO2
Secondary outcome
the effects of prolonged deep PSA on the arterial blood gas and pH
Background summary
Background and study aims:
Atrial fibrillation (AF) is a common sustained rhythm disorder. Pulmonary vein isolation (PVI) is the standard therapeutic treatment for symptomatic AF.
This procedure may cause discomfort to the patient.
Therefore, PVI is usually performed under procedural sedation and analgesia (PSA).
PSA is associated with respiratory depression which leads to alveolar hypoventilation and resultating in increased arterial CO2 levels.
There is no data available regarding the actual effect of PSA on the arterial CO2 and the blood gas.
We hypothesize that prolonged deep PSA increases the arterial CO2 levels. Increased levels of CO2 lead to a change in the pH of the blood, i.e. a respiratory acidosis. Although there are no obvious adverse effects of short-term acidosis, it is not a physiologically normal condition.
study population:
Patients between 18 and 80 years, which are scheduled for a pulmonary vein isolation with PSA and is willing to participatie in this trail.
what does the study involve?
Patients who are included in the study will get an arterial catheter prior to the PSA.
Every 30 minutes a blood samples will be drawn from the catheter to analyse
possible benefits and risks of participating:
There is a minimal risk related to the arterial cannulation. But the incidence is low and arterial cannulation is a relatively safe procedure.
There is no benefit for the patients who participate in the study. The goal is to better understand the side effects of PSA
Study objective
We hypothesize that prolonged deep PSA increases the arterial CO2 levels
Study design
start just before the pulmonale vein isolation and end 60 minutes after the procedure.
Intervention
none
Inclusion criteria
1. Pulmonary vein isolation performed under PSA
2. Age 18-80 years
3. ASA classification 1 or 2
4. Informed consent
Exclusion criteria
1. Pregnancy
2. BMI >30
3. BMI <18
4. Obstructive sleep apnea syndrome
5. COPD / Astma
6. Known bleeding disorders
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7812 |
CCMO | NL67983.091.18 |
OMON | NL-OMON46065 |