Pre-oxygenation With High-flow Nasal Cannula in Caesarian Section Under General Anesthesia
NCT04711317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2022-12-20
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.
Conditions
- Pregnancy Related
- Anesthesia
- Oxygen Deficiency
- Cesarean Section Complications
Interventions
- DEVICE
-
Nasal high flow oxygen
Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen
Sponsors & Collaborators
-
Danderyds Hospital, Stockholm, Sweden
collaborator UNKNOWN -
Stockholm South General Hospital
collaborator OTHER -
Karlstad Central Hospital
collaborator OTHER -
Östra Hospital
collaborator OTHER -
Karolinska University Hospital
lead OTHER
Principal Investigators
-
Malin Jonsson Fagerlund · Karolinska University Hospital and Karolinska Insitutet
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-03
- Primary Completion
- 2022-11-30
- Completion
- 2022-11-30
Countries
- Sweden
Study Locations
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