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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711317 on ClinicalTrials.gov