Pre-oxygenation With High-flow Nasal Cannula in Caesarian Section Under General Anesthesia
NCT ID: NCT04711317
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2021-03-03
2022-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Preoxygenation with nasal high flow oxygen
Preoxygenation with nasal high flow oxygen
Nasal high flow oxygen
Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen
Control group
Standard preoxygenation according to hospital protocol with tight fitting facemask
No interventions assigned to this group
Interventions
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Nasal high flow oxygen
Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen
Eligibility Criteria
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Inclusion Criteria
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
2. Dependency on non-invasive ventilation to maintain oxygen saturation
18 Years
FEMALE
No
Sponsors
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Danderyds Hospital, Stockholm, Sweden
UNKNOWN
Stockholm South General Hospital
OTHER
Karlstad Central Hospital
OTHER
Östra Hospital
OTHER
Karolinska University Hospital
OTHER
Responsible Party
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Malin Jonsson Fagerlund
Senior Consultant, Associate Professor
Principal Investigators
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Malin Jonsson Fagerlund
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital and Karolinska Insitutet
Locations
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Karlstads Centralsjukhus
Karlstad, , Sweden
Danderyds Hospital
Stockholm, , Sweden
Karolinska University Hospital, Solna
Stockholm, , Sweden
Södersjukhuset
Stockholm, , Sweden
Countries
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Other Identifiers
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PRIOROB
Identifier Type: -
Identifier Source: org_study_id