Critical IllnessHiPOXICNCT05883137
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
An observational study of Critical Illness and Respiratory Failure, run by Region Stockholm at 1 site in Sweden.
Trial summary
Intubation in the intensive care unit is a standard procedure with a high risk of adverse events such as hypoxaemia and cardiovascular instability. However, it is demonstrated that HFNO (High Flow Nasal Oxygen) for pre and perioxygenation is feasible and, in many situations, prolongs the safe apnoeic period after… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critical Illness, Respiratory Failure, Multi Organ Failure
- What is being tested?
- Optiflow Switch
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 25 Sep 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult critically ill patients requiring intubation in the intensive care unit at Karolinska University Hospital Solna, Sweden will be included.
Who may be able to join
- Adult, ≥18 years old
- Intensive care patients that require tracheal intubation for any indication
Who cannot join
- Patients with skull or facial injuries where the application of nasal cannula is to be avoided, decided by the intensivist.
- Pregnancy
- Total nasal obstruction
- Deemed not suitable for any other reason than the aforementioned
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Stockholm County, 17176
Ida-Maria Forsberg, PhD, +46704381445, ida-maria.forsberg@regionstockholm.se
About this study
Official title: High-flow Nasal Oxygenation for Apnoeic Oxygenation With Optiflow Switch During Intubation of the Critically Ill Adult- a Prospective Before-and-after Study
Intubation in the intensive care unit is a standard procedure with a high risk of adverse events such as hypoxaemia and cardiovascular instability. However, it is demonstrated that HFNO (High Flow Nasal Oxygen) for pre and perioxygenation is feasible and, in many situations, prolongs the safe apnoeic period after anaesthesia induction. Previous data of the use of HFNO during intubation of the critically ill is conflicting.
With the new device Optiflow Switch, which allow its combination with NIV or tight facemask with perioxygenation, we aim to evaluate whether this could reduce intubation-related hypoxaemia and other adverse events.
The general purpose of this project is to compare the addition of Optiflow Switch for pre- and perioxygenation to traditional preoxygenation using a tight-fitting mask or NIV during intubation in adult intensive care patients in a prospective before-and-after study design.
Read the detailed description
This study aims to investigate whether apnoeic oxygenation with Optiflow Switch during tracheal intubation of the critically ill may prevent severe hypoxaemic events. Critically ill patients requiring intubation in the intensive care unit will be preoxygenated with tight facemask/NIV and Optiflow Switch or only tight facemask/ NIV.
During a period of 6-12 months with an aim to include a minimum of 50 patients, patients will be preoxygenated according to routine practice, 100% oxygen via a tight-fitting mask or NIV. During the following 6-12 months, we will change the clinical routine to adding HFNO with Optiflow Switch. During this time, patients, without contraindications will be pre and perioxygenated with HFNO, Optiflow Switch 40-70 L/min, 100 % O2, in combination with a tight facemask or NIV.
Before preoxygenation, the need for and methods for oxygen delivery is noted. Baseline patient characteristics (age, BMI, comorbidities, smoking history, airway related data) and the reason for intensive care admission and intubation will be registered. Scores for physiological compromise and length of intensive care prior to intubation will be noted.
In both groups, the duration of preoxygenation and drugs for anaesthesia induction are chosen by the intensive care physician responsible. Blood gas analysis for arterial oxygen and carbon dioxide partial pressure will be analysed before and after intubation. Before, during and after intubation, vital parameters will be registered.
Intubation-related data and immediate complications such as arterial hypotension, severe cardiac arrhythmia, cardiac arrest, death, oesophageal intubation, regurgitation, or a need for a surgical airway will be noted. Later complications such as ventilator-associated pneumonia and mortality at day 28 as well as duration of mechanical ventilation, length of stay in ICU will be registered.
Patients with contraindications against HFNO and if the responsible anaesthetist is not comfortable using HFNO will be preoxygenated with a traditional facemask or NIV and included in the study group of traditional preoxygenation.
Data will also be collected from the intensive care patient chart regarding all intubations during the study period in order to find patients not included in the study.
- Conditions
- Critical Illness, Respiratory Failure, Multi Organ Failure, Hypoxia
- Being tested
- Optiflow Switch
- Keywords
- Apnoeic oxygenation, Airway management, Intensive care, Critical care
- Medical subject headings
- Critical Illness, Respiratory Insufficiency, Multiple Organ Failure, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow SwitchDevice
High flow nasal oxygen with the Optiflow Switch device
| Study group | Role | What they receive |
|---|---|---|
| Tight facemask or NIV | Preoxygenation with tight fitting facemask or NIV (non-invasive ventilation) according to the paitents need before anaesthesia induction. | |
| High Flow Nasal Oxygen and Tight facemask/ NIV | Pre and peri-oxygenation with HFNO using Optiflow Switch in addition to tight fitting facemask or NIV (non-invasive ventilation). Receives: Device: Optiflow Switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation up until 5 minutes after intubation
Desaturation (below 90% SpO2 or >5 % if <90% after preoxygenation) up until 5 minutes after intubation in patients receiving standard preoxygenation or with the addition of perioxygenation with HFNO.
Measured: 5 minutes post intubation
Secondary outcomes (11)
Frequency of complications
Difference of frequency of complications (severe arrhythmias or hypotension, cardiac arrest, death) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 5 minutes
Change of intubation method
Difference in change of intubation method when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 5 minutes
Intensive care length of stay
Difference in long-time intensive care outcome (length of stay, 30-day mortality, ventilator-induced pneumonia) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 30 days
ETCO2 in the first breath after intubation
Difference in ETCO2 in the first breath after intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 5 minutes
Duration of intubation
Difference in duration of intubation (from the start of laryngoscopy until ETCO2 is registered) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 5 minutes
Arterial oxygen and carbon dioxide levels after intubation
Difference in arterial oxygen and carbon dioxide levels after intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 30 minutes
Perceived intubation difficulties
Difference in graded (scale 1-5) perceived difficulty during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 30 minutes
Number of intubation attempts
Difference in number of intubation attempts when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 30 minutes
Number of oesophageal intubations
Difference in number of oesophageal intubations when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 30 minutes
30-day mortality
Difference in 30-day mortality when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 30 days
Perceived operator stress
Difference in perceived operator stress during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start25 Sep 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883137
- Sponsor's protocol ID
- 2023-0063201
- Other IDs
- 2023
- Acronym
- HiPOXIC
- Status last verified
- Nov 2024
- First submitted
- 11 May 2023
- Last updated
- 11 Apr 2025
- 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Oxygenation for Apnoeic Oxygenation With Optiflow Switch During Intubation of the Critically Ill Adult- a Prospective Before-and-after Study
- ClinicalTrials.gov ID
- NCT05883137
- Acronym / sponsor ID
- HiPOXIC / 2023-0063201
- Conditions
- Critical Illness, Respiratory Failure, Multi Organ Failure, Hypoxia
- Keywords
- Apnoeic oxygenation, Airway management, Intensive care, Critical care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 May 2023 (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.
Intubation in the intensive care unit is a standard procedure with a high risk of adverse events such as hypoxaemia and cardiovascular instability. However, it is demonstrated that HFNO (High Flow Nasal Oxygen) for pre and perioxygenation is feasible and, in many situations, prolongs the safe apnoeic period after anaesthesia induction. Previous data of the use of HFNO during intubation of the critically ill is conflicting.
With the new device Optiflow Switch, which allow its combination with NIV or tight facemask with perioxygenation, we aim to evaluate whether this could reduce intubation-related hypoxaemia and other adverse events.
The general purpose of this project is to compare the addition of Optiflow Switch for pre- and perioxygenation to traditional preoxygenation using a tight-fitting mask or NIV during intubation in adult intensive care patients in a prospective before-and-after study design.
Detailed description
This study aims to investigate whether apnoeic oxygenation with Optiflow Switch during tracheal intubation of the critically ill may prevent severe hypoxaemic events. Critically ill patients requiring intubation in the intensive care unit will be preoxygenated with tight facemask/NIV and Optiflow Switch or only tight facemask/ NIV.
During a period of 6-12 months with an aim to include a minimum of 50 patients, patients will be preoxygenated according to routine practice, 100% oxygen via a tight-fitting mask or NIV. During the following 6-12 months, we will change the clinical routine to adding HFNO with Optiflow Switch. During this time, patients, without contraindications will be pre and perioxygenated with HFNO, Optiflow Switch 40-70 L/min, 100 % O2, in combination with a tight facemask or NIV.
Before preoxygenation, the need for and methods for oxygen delivery is noted. Baseline patient characteristics (age, BMI, comorbidities, smoking history, airway related data) and the reason for intensive care admission and intubation will be registered. Scores for physiological compromise and length of intensive care prior to intubation will be noted.
In both groups, the duration of preoxygenation and drugs for anaesthesia induction are chosen by the intensive care physician responsible. Blood gas analysis for arterial oxygen and carbon dioxide partial pressure will be analysed before and after intubation. Before, during and after intubation, vital parameters will be registered.
Intubation-related data and immediate complications such as arterial hypotension, severe cardiac arrhythmia, cardiac arrest, death, oesophageal intubation, regurgitation, or a need for a surgical airway will be noted. Later complications such as ventilator-associated pneumonia and mortality at day 28 as well as duration of mechanical ventilation, length of stay in ICU will be registered.
Patients with contraindications against HFNO and if the responsible anaesthetist is not comfortable using HFNO will be preoxygenated with a traditional facemask or NIV and included in the study group of traditional preoxygenation.
Data will also be collected from the intensive care patient chart regarding all intubations during the study period in order to find patients not included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight facemask or NIV | – | –Preoxygenation with tight fitting facemask or NIV (non-invasive ventilation) according to the paitents need before anaesthesia induction. |
| High Flow Nasal Oxygen and Tight facemask/ NIV | – | Device: Optiflow SwitchPre and peri-oxygenation with HFNO using Optiflow Switch in addition to tight fitting facemask or NIV (non-invasive ventilation). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult critically ill patients requiring intubation in the intensive care unit at Karolinska University Hospital Solna, Sweden will be included.
Key inclusion criteria (2 listed)
- Adult, ≥18 years old
- Intensive care patients that require tracheal intubation for any indication
Key exclusion criteria (4 listed)
- Patients with skull or facial injuries where the application of nasal cannula is to be avoided, decided by the intensivist.
- Pregnancy
- Total nasal obstruction
- Deemed not suitable for any other reason than the aforementioned
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 |
|---|---|---|
| Optiflow SwitchHigh flow nasal oxygen with the Optiflow Switch device | Device | High Flow Nasal Oxygen and Tight facemask/ NIV |
Primary outcome
Desaturation up until 5 minutes after intubation
Time frame: 5 minutes post intubation
Desaturation (below 90% SpO2 or >5 % if <90% after preoxygenation) up until 5 minutes after intubation in patients receiving standard preoxygenation or with the addition of perioxygenation with HFNO.
11 secondary outcomes
Frequency of complications
Time frame: 5 minutes
Change of intubation method
Time frame: 5 minutes
Intensive care length of stay
Time frame: 30 days
ETCO2 in the first breath after intubation
Time frame: 5 minutes
Duration of intubation
Time frame: 5 minutes
Arterial oxygen and carbon dioxide levels after intubation
Time frame: 30 minutes
Perceived intubation difficulties
Time frame: 30 minutes
Number of intubation attempts
Time frame: 30 minutes
Number of oesophageal intubations
Time frame: 30 minutes
30-day mortality
Time frame: 30 days
Perceived operator stress
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Respiratory Failure, run by Region Stockholm at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida-Maria Forsberg, PhD (+ 46704381445, ida-maria.forsberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desaturation up until 5 minutes after intubation (time frame: 5 minutes post 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 11 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.