Pregnancy Related, Anesthesia, Oxygen Deficiency, Cesarean Section Complications
Conditions
Keywords
Preoxygenation, Perioxygenation, Nasal high flow oxygen, Cesarian sectio
Brief summary
The investigators and other groups have demonstrated that high-flow nasal oxygen used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. The investigators also have data from a recent study that indicates that high-flow nasal oxygen might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. The studies investigating the concept of high-flow nasal oxygen has up to this date excluded pregnant women. Pregnant woman is a patient group with known difficulties to maintain adequate saturation levels during apnoea. Due to smaller functional residual capacity their oxygen stores after preoxygenation are smaller compared to patients with a normal body mass index. The pregnant woman also have a higher oxygen demand and metabolism due to the growing placenta and the fetus. Pregnant women are therefore a patient group where a method that could prolong time until desaturation would be even more valuable and potentially could save lives. Based on the above, the investigators now aim to conduct a clinical pilot study, where pregnant women undergoing caesarian section under general anesthesia are pre and perioxygenated with high-flow nasal oxygen. Data from that group will be compared with patients preoxygenated in a traditional manner with tight facemask. This study is done to evaluate an established technique on a patient category that in theory could gain a lot from it.
Interventions
DEVICENasal high flow oxygen
Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen
Sponsors
Danderyds Hospital, Stockholm, Sweden
Stockholm South General Hospital
Karlstad Central Hospital
Östra Hospital
Karolinska University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One intervention group that is compared to a control group that is standard treatment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult, \>18 years old 2. Caesarian section under general anesthesia. 3. Pregnant in week 30 or later 4. Capable of understanding the study information and signing the written consent.
Exclusion criteria
1. BMI \>45 2. Dependency on non-invasive ventilation to maintain oxygen saturation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with peripheral arterial oxygen saturation below 93% from start of pre-oxygenation until one minute after tracheal intubation and comparison between intervention and control | Up to 1 minute after intubation | arterial peripheral oxygen saturation |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Endtidal concentration of oxygen after intubation between intervention and control | The first breaths after intubation eg. within 20 seconds of intubation |
| Comparison of Endtidal carbondioxide concentration after intubation between intervention and control | The first breaths after intubation eg. within 20 seconds of intubation |
| Comparison of Number of patients with regurgitation of gastric contents between intervention and control | During intubation eg up to 0 seconds after intubation |
Countries
Sweden
Outcome results
None listed