Skip to main content
OpenTrials
Completed

NCT Number: NCT04711317

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karlstads Centralsjukhus, Karlstad, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • BMI >45
  • Dependency on non-invasive ventilation to maintain oxygen saturation

Treatment and study plan

Nasal High Flow Oxygen

Device

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

Primary outcomes

  1. 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

  1. Comparison of Endtidal concentration of oxygen after intubation between intervention and control

    Time frame: The first breaths after intubation eg. within 20 seconds of intubation

  2. Comparison of Endtidal carbondioxide concentration after intubation between intervention and control

    Time frame: The first breaths after intubation eg. within 20 seconds of intubation

  3. Comparison of Number of patients with regurgitation of gastric contents between intervention and control

    Time frame: During intubation eg up to 0 seconds after intubation

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Danderyds Hospital, Stockholm, Sweden
  • Karlstad Central Hospital
  • Stockholm South General Hospital
  • Östra Hospital

Registry information

Official study title

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

Acronym: PRIOROB

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.