Pregnancy RelatedPRIOROBNCT04711317
Pre-oxygenation With High-flow Nasal Cannula in Caesarian Section Under General Anesthesia
A study testing Nasal high flow oxygen in people with Pregnancy Related and Anesthesia, run by Karolinska University Hospital at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Anesthesia, Oxygen Deficiency
- What is being tested?
- Nasal high flow oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesSweden
- Study dates
- 3 Mar 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- BMI >45
- Dependency on non-invasive ventilation to maintain oxygen saturation
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Karlstads Centralsjukhus
Karlstad
Danderyds Hospital
Stockholm
Karolinska University Hospital, Solna
Stockholm
Södersjukhuset
Stockholm
About this study
Official title: 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.
- Being tested
- Nasal high flow oxygen
- Keywords
- Preoxygenation, Perioxygenation, Nasal high flow oxygen, Cesarian sectio
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flow oxygenDevice
Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen
| Study group | Role | What they receive |
|---|---|---|
| Preoxygenation with nasal high flow oxygen | Experimental | Preoxygenation with nasal high flow oxygen Receives: Device: Nasal high flow oxygen |
| Control group | No intervention | Standard preoxygenation according to hospital protocol with tight fitting facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 minute after intubation
Secondary outcomes (3)
Comparison of Endtidal concentration of oxygen after intubation between intervention and control
Measured: The first breaths after intubation eg. within 20 seconds of intubation
Comparison of Endtidal carbondioxide concentration after intubation between intervention and control
Measured: 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
Measured: During intubation eg up to 0 seconds after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start3 Mar 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- One intervention group that is compared to a control group that is standard treatment.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyds Hospital, Stockholm, Sweden, Stockholm South General Hospital, Karlstad Central Hospital, Östra Hospital
- Responsible party
- Principal investigator, Malin Jonsson Fagerlund, Karolinska University Hospital
- Investigators
- Malin Jonsson Fagerlund, Principal investigator, Karolinska University Hospital and Karolinska Insitutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711317
- Sponsor's protocol ID
- PRIOROB
- Acronym
- PRIOROB
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2020
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-oxygenation With High-flow Nasal Cannula in Pregnant Women Undergoing Caesarian Section Under General Anesthesia - a Pilot Study
- ClinicalTrials.gov ID
- NCT04711317
- Acronym / sponsor ID
- PRIOROB / PRIOROB
- Keywords
- Preoxygenation, Perioxygenation, Nasal high flow oxygen, Cesarian sectio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Danderyds Hospital, Stockholm, Sweden, Stockholm South General Hospital, Karlstad Central Hospital, Östra Hospital
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One intervention group that is compared to a control group that is standard treatment.
| Arm | Type | Receives |
|---|---|---|
| Preoxygenation with nasal high flow oxygen | Experimental | Device: Nasal high flow oxygenPreoxygenation with nasal high flow oxygen |
| Control group | No intervention | –Standard preoxygenation according to hospital protocol with tight fitting facemask |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- BMI >45
- Dependency on non-invasive ventilation to maintain oxygen saturation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal high flow oxygenPregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen | Device | Preoxygenation with nasal high flow oxygen |
Primary outcome
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
Time frame: Up to 1 minute after intubation
arterial peripheral oxygen saturation
3 secondary outcomes
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
Comparison of Endtidal carbondioxide concentration after intubation between intervention and control
Time frame: 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
Time frame: During intubation eg up to 0 seconds after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malin Jonsson Fagerlund principal investigator
Karolinska University Hospital and Karolinska Insitutet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal high flow oxygen in people with Pregnancy Related and Anesthesia, run by Karolinska University Hospital at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 1 minute after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.