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

K

Karolinska University Hospital

Status

Completed

Conditions

Cesarean Section Complications
Pregnancy Related
Oxygen Deficiency
Anesthesia

Treatments

Device: Nasal high flow oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT04711317
PRIOROB

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Preoxygenation with nasal high flow oxygen
Experimental group
Description:
Preoxygenation with nasal high flow oxygen
Treatment:
Device: Nasal high flow oxygen
Control group
No Intervention group
Description:
Standard preoxygenation according to hospital protocol with tight fitting facemask

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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