Clinical Trials Directory

Trials / Completed

CompletedNCT04711317

Pre-oxygenation With High-flow Nasal Cannula in Caesarian Section Under General Anesthesia

Pre-oxygenation With High-flow Nasal Cannula in Pregnant Women Undergoing Caesarian Section Under General Anesthesia - a Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Karolinska University Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICENasal high flow oxygenPregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen

Timeline

Start date
2021-03-03
Primary completion
2022-11-30
Completion
2022-11-30
First posted
2021-01-15
Last updated
2022-12-20

Locations

4 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT04711317. Inclusion in this directory is not an endorsement.