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

Not Applicable

Completed

• Conditions: Pregnancy Related; Anesthesia; Oxygen Deficiency; Cesarean Section Complications

• Registration Number: NCT04711317
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-15
• Study Start: 2021-03-03
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	Up to 1 minute after intubation	arterial peripheral oxygen saturation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Karlstads Centralsjukhus; 🇸🇪 Karlstad, Sweden

Danderyds Hospital; 🇸🇪 Stockholm, Sweden

Karolinska University Hospital, Solna; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden