In this study we want to show what the consequences are of the respiratory depression that accompanies prolonged PSA
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
procedurele sedatie en analgesie (PSA)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate the effects of prolonged
deep PSA on the arterial CO2.
Secondary outcome
The secondary objective if this study is to evaluate the effects of prolonged
deep PSA on the arterial blood gas and pH.
Background summary
Atrial fibrillation (AF) is a common sustained rhythm disorder and pulmonary
vein isolation (PVI) is the standard therapeutic treatment for symptomatic AF2.
This procedure takes a longer period of time and may cause discomfort to the
patient.
Therefore, PVI is usually performed under procedural anesthesia and analgesia
(PSA).
PSA is be associated with respiratory depression which leads to alveolar
hypoventilation and resultating in increased arterial CO2 levels.
There is no data available what the actual effect of PSA on the arterial CO2
and the blood gas is.
We hypothesize that prolonged deep PSA increases the arterial CO2 levels.
Study objective
In this study we want to show what the consequences are of the respiratory
depression that accompanies prolonged PSA
Study design
single centre prospective observational study
Study burden and risks
Patient who are included in the study will get an arterial catheter prior to
the PSA.
Depending on the duration of the procedure, a numer of blood samples are taken
from the catheter to analyse. All other measurement and treatment to the
patients are part of standard care.
Patients have al little risk of incidence related to the arterial cannulation.
But the incidence is rare and the arterial cannulation is a relatively safe
procedure.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
patients, ASA 1-2, between 18 and 80 years, which are scheduled for a pulmonary vein isolation performed with PSA.
Exclusion criteria
Pregnancy
BMI >30
BMI <18
Obstructive sleep apnea syndrome
COPD / Astma
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67983.091.18 |
| OMON | NL-OMON26433 |