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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Cesarean Section Complications; Oxygen Deficiency; Anesthesia
• Intervention / Treatment: Device: Nasal high flow oxygen

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Karlstad, Sweden
    • Karlstads centralsjukhus
  • Stockholm, Sweden
    • Södersjukhuset
  • Stockholm, Sweden
    • Danderyds Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital, Solna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoxygenation with nasal high flow oxygen	Device: Nasal high flow oxygen; Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen
No Intervention: Control group; Standard preoxygenation according to hospital protocol with tight fitting facemask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Karlstad Central Hospital; Stockholm South General Hospital; Danderyds Hospital, Stockholm, Sweden; Östra Hospital
• Investigators: Principal Investigator: Malin Jonsson Fagerlund, Karolinska University Hospital and Karolinska Insitutet

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Preoxygenation; Perioxygenation; Nasal high flow oxygen; Cesarian sectio
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: PRIOROB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No