Anesthesia Clinical Trial
— PRIOROBOfficial title:
Pre-oxygenation With High-flow Nasal Cannula in Pregnant Women Undergoing Caesarian Section Under General Anesthesia - a Pilot Study
NCT number | NCT04711317 |
Other study ID # | PRIOROB |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 3, 2021 |
Est. completion date | November 30, 2022 |
Verified date | December 2022 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karlstads Centralsjukhus | Karlstad | |
Sweden | Danderyds Hospital | Stockholm | |
Sweden | Karolinska University Hospital, Solna | Stockholm | |
Sweden | Södersjukhuset | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Danderyds Hospital, Stockholm, Sweden, Karlstad Central Hospital, Östra Hospital, Stockholm South General Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Comparison of Endtidal concentration of oxygen after intubation between intervention and control | The first breaths after intubation eg. within 20 seconds of intubation | ||
Secondary | Comparison of Endtidal carbondioxide concentration after intubation between intervention and control | The first breaths after intubation eg. within 20 seconds of intubation | ||
Secondary | Comparison of Number of patients with regurgitation of gastric contents between intervention and control | During intubation eg up to 0 seconds after intubation |
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