Clinical trial NCT04711317: Pre-oxygenation With High-flow Nasal Cannula in Caesarian Section Under General Anesthesia
Official title: Pre-oxygenation With High-flow Nasal Cannula in Pregnant Women Undergoing Caesarian Section Under General Anesthesia - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Anesthesia
Oxygen Deficiency
Cesarean Section Complications
Keywords: Preoxygenation
Perioxygenation
Nasal high flow oxygen
Cesarian sectio
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Danderyds Hospital, Stockholm, Sweden
name: Stockholm South General Hospital
name: Karlstad Central Hospital
name: Östra Hospital
First posted: 2021-01-15
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: One intervention group that is compared to a control group that is standard treatment.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 1 minute after intubation
Secondary outcomes:
measure: Comparison of Endtidal concentration of oxygen after intubation between intervention and control
timeFrame: The first breaths after intubation eg. within 20 seconds of intubation
measure: Comparison of Endtidal carbondioxide concentration after intubation between intervention and control
timeFrame: The first breaths after intubation eg. within 20 seconds of intubation
measure: Comparison of Number of patients with regurgitation of gastric contents between intervention and control
timeFrame: During intubation eg up to 0 seconds after intubation
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Karlstads Centralsjukhus
city: Stockholm
country: Sweden
facility: Danderyds Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska University Hospital and Karolinska Insitutet
name: Malin Jonsson Fagerlund
role: PRINCIPAL_INVESTIGATOR
References: