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| Name | Class |
|---|---|
| Danderyds Hospital, Stockholm, Sweden | UNKNOWN |
| Stockholm South General Hospital | OTHER |
| Karlstad Central Hospital | OTHER |
| Östra Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoxygenation with nasal high flow oxygen | Experimental | Preoxygenation with nasal high flow oxygen |
|
| Control group | No Intervention | Standard preoxygenation according to hospital protocol with tight fitting facemask |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal high flow oxygen | Device | Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | arterial peripheral oxygen saturation | Up to 1 minute after intubation |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malin Jonsson Fagerlund | Karolinska University Hospital and Karolinska Insitutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karlstads Centralsjukhus | Karlstad | Sweden | ||||
| Danderyds Hospital |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
One intervention group that is compared to a control group that is standard treatment.
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| 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 |
| Stockholm |
| Sweden |
| Karolinska University Hospital, Solna | Stockholm | Sweden |
| Södersjukhuset | Stockholm | Sweden |