intraoperativ decline of cerebral oxygen saturation
Conditions
Interventions
Group 1: All inculded patients. Comparison between baseline crSO2 (before capnoperitoneum) and crSO2 at different timepoints after insufflation.
Sponsors
Universitätsmedizin MainzKlinik für Anästhesiologie
Eligibility
Sex/Gender
All
Age
No minimum to 12 Months
Inclusion criteria
Inclusion criteria: - Patients younger than 1 year (corrected age) - written declaration of consent from a legal representative - scheduled laparoscopic surgery or intervention under capnoperitonial insufflation
Exclusion criteria
Exclusion criteria: -Patient is older then 1 year (corrected age) - legal represantiv does not provide declaration of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical study is to test the following alternative hypothesis: "The creation of a capnoperitoneum reduces the regional oxygen saturation of the brain in children iyounger then one year". In analogy to Katama et al. the crSO2 at a point before capnoperitoneum insufflation is compared with a point in time shortly after capnoperitoneum insufflation. For this purpose, the points in time 2a: “Beginning of sterile covering” and point in time 3b: “1 minute after application of the capnoperitoneum” were defined as the points in time to be examined. The alternative hypothesis should be accepted as true if the change is clinically significant (>8%) and the alpha error is less than 5%. Otherwise, the null hypothesis "The insufflation and maintenance of a capnoperitoneum has no influence on the regional oxygen saturation of the brain in children in the first year of life" should be retained. The following additional points in time are recorded (for the evaluation of secondary endpoints): 1a. Completion of sensor placement 1b. Beginning of pre-oxygenation 1c. Beginning of anesthesia induction 1d. Beginning of mask ventilation 1e. Intubation 1f. Clearance 2a. Begin sterile draping 2 B. Begin of surgery 3a. Insufflation of capnoperitoneum 3b. 1 min after insufflation of the capnoperitoneum 4. Trendelenburg location 5. End of Trendelenburg 6. End of capnoperitoneum 6a. Last regular measurement before the end of the capnoperitoneum 6b. 1 min after the end of capnoperitoneum 7. End of surgical suture 8. Extubation 9. End of anesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the effect of various parameters on the crSO2, the greatest deviation of the crSO2 from the established baseline in the respective examination period (initiation, operation) is determined for each patient. Simple linear regressions (or, where these are not applicable, logistic regressions) are then carried out with the specified patient characteristics as independent variables and the drop in the crSO2 value as dependent variable. In order to identify variables that could serve as preoperative and intraoperative predictors for a drop in brain oxygen saturation, the respective regression models are examined for multicolinearity and adjusted under careful consideration before a backward selection is then carried out. The effects of the influencing factors on the ORI (Oxygen Reserve INdex) are examined in the same way as the relationships between crSO2 and the clinical parameters recorded. In order to investigate the effects of the capnoperitoneum on the clinical parameters of the patients, following Kamata et al. calculated the arithmetic mean and the standard deviations of the crSO2 for different points in time. The parameters are examined with the help of a paired, two-sided t-test for a significant difference at the respective comparison time. The following potential influencing factors on the regional oxygen saturation of the brain or the ORI or clinical parameters that can be influenced by the insufflation of capnoperitoneum are examined: -[corrected] age in weeks -Weight in kilograms -Size in centimeters -prematurity -Birth weight in grams -Gender -Pre-existing illness -ASA classification -Baseline Hb and lactate (if determined independently of study) -intervention -duration of operation -Storage -Intra-abdominal gas flow -Intra-abdominal pressure -Duration of capnoperitoneum insufflation -Anesthetic induction procedures -Duration of pre-oxygenation - Duration of mask ventilation -Time to intubate -Medications used for inductio | — |
Countries
Germany
Contacts
Public ContactMoritz Hauff
Universitätsmedizin Mainz, Klinik für Anästhesiologie
Outcome results
None listed