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

Anesthesia Clinical Trial

— PRIOROB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711317
• Other study ID #: PRIOROB
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Cesarean Section Complications
• Hypoxia
• Oxygen Deficiency
• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
Sweden	Karlstads Centralsjukhus	Karlstad
Sweden	Danderyds Hospital	Stockholm
Sweden	Karolinska University Hospital, Solna	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska University Hospital	Danderyds Hospital, Stockholm, Sweden, Karlstad Central Hospital, Östra Hospital, Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	arterial peripheral oxygen saturation	Up to 1 minute after intubation
Secondary	Comparison of Endtidal concentration of oxygen after intubation between intervention and control		The first breaths after intubation eg. within 20 seconds of intubation
Secondary	Comparison of Endtidal carbondioxide concentration after intubation between intervention and control		The first breaths after intubation eg. within 20 seconds of intubation
Secondary	Comparison of Number of patients with regurgitation of gastric contents between intervention and control		During intubation eg up to 0 seconds after intubation