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Clinical Trials/NCT04711317
NCT04711317
Completed
Not Applicable

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

Karolinska University Hospital4 sites in 1 country34 target enrollmentMarch 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Karolinska University Hospital
Enrollment
34
Locations
4
Primary Endpoint
Number of patients with peripheral arterial oxygen saturation below 93% from start of pre-oxygenation until one minute after tracheal intubation and comparison between intervention and control
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 3, 2021
End Date
November 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Malin Jonsson Fagerlund

Senior Consultant, Associate Professor

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult, \>18 years old
  • Caesarian section under general anesthesia.
  • Pregnant in week 30 or later
  • Capable of understanding the study information and signing the written consent.

Exclusion Criteria

  • Dependency on non-invasive ventilation to maintain oxygen saturation

Outcomes

Primary Outcomes

Number of patients with peripheral arterial oxygen saturation below 93% from start of pre-oxygenation until one minute after tracheal intubation and comparison between intervention and control

Time Frame: Up to 1 minute after intubation

arterial peripheral oxygen saturation

Secondary Outcomes

  • Comparison of Endtidal concentration of oxygen after intubation between intervention and control(The first breaths after intubation eg. within 20 seconds of intubation)
  • Comparison of Endtidal carbondioxide concentration after intubation between intervention and control(The first breaths after intubation eg. within 20 seconds of intubation)
  • Comparison of Number of patients with regurgitation of gastric contents between intervention and control(During intubation eg up to 0 seconds after intubation)

Study Sites (4)

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