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

NCT04711317 | Completed

• 1 other identifier: PRIOROB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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.

Conditions

Pregnancy Related; Anesthesia; Oxygen Deficiency; Cesarean Section Complications

Keywords

Preoxygenation; Perioxygenation; Nasal high flow oxygen; Cesarian sectio

Outcome Measures

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

  arterial peripheral oxygen saturation

  Up to 1 minute after intubation

Secondary Outcomes (3)

• 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 Arms (2)

Preoxygenation with nasal high flow oxygen

EXPERIMENTAL

Preoxygenation with nasal high flow oxygen

Device: Nasal high flow oxygen

Control group

NO INTERVENTION

Standard preoxygenation according to hospital protocol with tight fitting facemask

Interventions

Nasal high flow oxygen DEVICE

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

Preoxygenation with nasal high flow oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Danderyds Hospital, Stockholm, Sweden: collaborator
• Stockholm South General Hospital: collaborator
• Karlstad Central Hospital: collaborator
• Östra Hospital: collaborator

Study Sites (4)

Karlstads Centralsjukhus

Karlstad, Sweden

Location

Danderyds Hospital

Stockholm, Sweden

Location

Karolinska University Hospital, Solna

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Malin Jonsson Fagerlund

  Karolinska University Hospital and Karolinska Insitutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Associate Professor

Model Details: One intervention group that is compared to a control group that is standard treatment.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 15, 2021
• Study Start: March 3, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)