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

Primary Purpose

Pregnancy Related, Anesthesia, Oxygen Deficiency

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Nasal high flow oxygen
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring Preoxygenation, Perioxygenation, Nasal high flow oxygen, Cesarian sectio

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Karlstads Centralsjukhus
  • Danderyds Hospital
  • Karolinska University Hospital, Solna
  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preoxygenation with nasal high flow oxygen

Control group

Arm Description

Preoxygenation with nasal high flow oxygen

Standard preoxygenation according to hospital protocol with tight fitting facemask

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of Endtidal concentration of oxygen after intubation between intervention and control
Comparison of Endtidal carbondioxide concentration after intubation between intervention and control
Comparison of Number of patients with regurgitation of gastric contents between intervention and control

Full Information

First Posted
December 9, 2020
Last Updated
December 19, 2022
Sponsor
Karolinska University Hospital
Collaborators
Danderyds Hospital, Stockholm, Sweden, Stockholm South General Hospital, Karlstad Central Hospital, Östra Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04711317
Brief Title
Pre-oxygenation With High-flow Nasal Cannula in Caesarian Section Under General Anesthesia
Acronym
PRIOROB
Official Title
Pre-oxygenation With High-flow Nasal Cannula in Pregnant Women Undergoing Caesarian Section Under General Anesthesia - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Danderyds Hospital, Stockholm, Sweden, Stockholm South General Hospital, Karlstad Central Hospital, Östra Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Anesthesia, Oxygen Deficiency, Cesarean Section Complications
Keywords
Preoxygenation, Perioxygenation, Nasal high flow oxygen, Cesarian sectio

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One intervention group that is compared to a control group that is standard treatment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preoxygenation with nasal high flow oxygen
Arm Type
Experimental
Arm Description
Preoxygenation with nasal high flow oxygen
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard preoxygenation according to hospital protocol with tight fitting facemask
Intervention Type
Device
Intervention Name(s)
Nasal high flow oxygen
Intervention Description
Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen
Primary Outcome Measure Information:
Title
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
Description
arterial peripheral oxygen saturation
Time Frame
Up to 1 minute after intubation
Secondary Outcome Measure Information:
Title
Comparison of Endtidal concentration of oxygen after intubation between intervention and control
Time Frame
The first breaths after intubation eg. within 20 seconds of intubation
Title
Comparison of Endtidal carbondioxide concentration after intubation between intervention and control
Time Frame
The first breaths after intubation eg. within 20 seconds of intubation
Title
Comparison of Number of patients with regurgitation of gastric contents between intervention and control
Time Frame
During intubation eg up to 0 seconds after intubation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: BMI >45 Dependency on non-invasive ventilation to maintain oxygen saturation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Jonsson Fagerlund
Organizational Affiliation
Karolinska University Hospital and Karolinska Insitutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karlstads Centralsjukhus
City
Karlstad
Country
Sweden
Facility Name
Danderyds Hospital
City
Stockholm
Country
Sweden
Facility Name
Karolinska University Hospital, Solna
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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