Acute Hypoxemic Respiratory FailurePreoxyEITNCT05962073
Comparison Physiological Effects According to Preoxygenation Method Using EIT
A study testing HFNC in people with Acute Hypoxemic Respiratory Failure, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Hypoxemia during endotracheal intubation is one of this procedure's most frequent and severe complications, which can lead to cardiac arrest and other adverse outcomes. Although various studies have been conducted to ensure the safety of endotracheal intubation, most of them have focused on the physiological changes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2023to 30 Jul 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 or older
- Acute respiratory failure is defined as follows: Tachypnea over 30 breaths/minute / Symptoms or signs of respiratory failure / PaO2/FiO2 less than 300
- When there is an indication for endotracheal intubation for mechanical ventilation
- When sufficient information and a consent form for the study are obtained from the patient or the patient's guardian
Who cannot join
- Coma with Glasgow score < 8
- Endotracheal intubation during CPR
- Contraindications for NIV: poor patient cooperation, recurrent vomiting, GI bleeding, severe craniofacial injury, upper airway obstruction, etc.
- Contraindications for RSI: complete upper airway obstruction, severe trauma obscuring cervical structures, etc.
- Implanted electronic medical devices (defibrillator, pacemaker or spinal cord stimulator)
- Skin damage or inadequate electrode contact due to wound dressing at the electrode site
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- BMI > 50
- Polydipsia
- Unmeasurable SpO2
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Trial of Preoxygenation Methods and Their Impacts on Endotracheal Intubation in Acute Respiratory Failure: an Electrical Impedance Tomography Study
Hypoxemia during endotracheal intubation is one of this procedure's most frequent and severe complications, which can lead to cardiac arrest and other adverse outcomes. Although various studies have been conducted to ensure the safety of endotracheal intubation, most of them have focused on the physiological changes during the procedure in surgical settings, where general anesthesia is administered to healthy subjects. However, the physiological characteristics of critically ill patients who require endotracheal intubation in the intensive care unit (ICU) may differ from those of healthy subjects. When comparing the oxygen saturation-dissociation curve of healthy subjects and critically ill patients, the latter show a steeper decline in oxygen saturation (SpO2) below 90% when hypoxemia occurs. Clinically, it is difficult to maintain or recover oxygen saturation when it drops. Therefore, preoxygenation is also essential for critically ill patients with a relatively small lung reservoir, as it can help maintain higher and longer oxygen saturation during endotracheal intubation. For this reason, apneic oxygenation was proposed in the 1950s as a method of oxygen delivery during general anesthesia for surgery, and clinical randomized controlled trials (RCTs) applying it to critically ill patients in the ICU have been conducted since 20 years ago. In an observational study by Macamn et al., the adjusted odds ratio (OR) of a bag valve mask was 1, while that of a high-flow nasal cannula (HFNC) was 5.75 and that of non-invasive ventilation (NIV) was 0.10 when different preoxygenation methods were used. n FLORARI 2, a large-scale clinical RCT comparing NIV and HFNC with or without apneic oxygenation, NIV was significantly more effective than HFNC in reducing severe hypoxemia. Based on these previous studies, the investigators can infer that supplying oxygen during laryngoscopy is not very effective in preventing hypoxemia in critically ill patients. However, there is no guideline on which device to choose for preoxygenation in the ICU, and NIV or HFNC are selected according to the operator's preference. This is because few studies have examined the physiological effects of these devices on patients. Therefore, in this study, the investigators aim to compare the clinical outcomes and adverse events of NIV and HFNC as preoxygenation methods for endotracheal intubation in critically ill patients with acute respiratory failure and to evaluate their physiological effects using electrical impedance tomography.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- HFNC
- Keywords
- electrical impedence tomography, preoxygenation, intubation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
High-flow oxygen therapy before intubation for preoxygenation
| Study group | Role | What they receive |
|---|---|---|
| NIV | No intervention | Non-invasive ventilation application for preoxygenation |
| HFNC | Active comparator | High flow oxygen therapy application for preoxygenation Receives: Device: HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest SpO2
Minimum SpO2 value during endotracheal intubation
Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Secondary outcomes (6)
EIT measurement
Change of T2-T1
Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Change of △EILI
Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Change of △EELI
Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Change of Overdistension
Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Change of Collapse
Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Change of Global Inhomogeneity Index
Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Why it stopped: Not approved for ethics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hypoxemic respiratory failure who required endotracheal intubation
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryoung-Eun Ko, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962073
- Sponsor's protocol ID
- PreoxyEIT
- Acronym
- PreoxyEIT
- Status last verified
- Apr 2024
- First submitted
- 3 Jul 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of Preoxygenation Methods and Their Impacts on Endotracheal Intubation in Acute Respiratory Failure: an Electrical Impedance Tomography Study
- ClinicalTrials.gov ID
- NCT05962073
- Acronym / sponsor ID
- PreoxyEIT / PreoxyEIT
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- electrical impedence tomography, preoxygenation, intubation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not approved for ethics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 27 Jul 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.
Hypoxemia during endotracheal intubation is one of this procedure's most frequent and severe complications, which can lead to cardiac arrest and other adverse outcomes. Although various studies have been conducted to ensure the safety of endotracheal intubation, most of them have focused on the physiological changes during the procedure in surgical settings, where general anesthesia is administered to healthy subjects. However, the physiological characteristics of critically ill patients who require endotracheal intubation in the intensive care unit (ICU) may differ from those of healthy subjects. When comparing the oxygen saturation-dissociation curve of healthy subjects and critically ill patients, the latter show a steeper decline in oxygen saturation (SpO2) below 90% when hypoxemia occurs. Clinically, it is difficult to maintain or recover oxygen saturation when it drops. Therefore, preoxygenation is also essential for critically ill patients with a relatively small lung reservoir, as it can help maintain higher and longer oxygen saturation during endotracheal intubation. For this reason, apneic oxygenation was proposed in the 1950s as a method of oxygen delivery during general anesthesia for surgery, and clinical randomized controlled trials (RCTs) applying it to critically ill patients in the ICU have been conducted since 20 years ago. In an observational study by Macamn et al., the adjusted odds ratio (OR) of a bag valve mask was 1, while that of a high-flow nasal cannula (HFNC) was 5.75 and that of non-invasive ventilation (NIV) was 0.10 when different preoxygenation methods were used. n FLORARI 2, a large-scale clinical RCT comparing NIV and HFNC with or without apneic oxygenation, NIV was significantly more effective than HFNC in reducing severe hypoxemia. Based on these previous studies, the investigators can infer that supplying oxygen during laryngoscopy is not very effective in preventing hypoxemia in critically ill patients. However, there is no guideline on which device to choose for preoxygenation in the ICU, and NIV or HFNC are selected according to the operator's preference. This is because few studies have examined the physiological effects of these devices on patients. Therefore, in this study, the investigators aim to compare the clinical outcomes and adverse events of NIV and HFNC as preoxygenation methods for endotracheal intubation in critically ill patients with acute respiratory failure and to evaluate their physiological effects using electrical impedance tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hypoxemic respiratory failure who required endotracheal intubation
| Arm | Type | Receives |
|---|---|---|
| NIV | No intervention | –Non-invasive ventilation application for preoxygenation |
| HFNC | Active comparator | Device: HFNCHigh flow oxygen therapy application for preoxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 or older
- Acute respiratory failure is defined as follows: Tachypnea over 30 breaths/minute / Symptoms or signs of respiratory failure / PaO2/FiO2 less than 300
- When there is an indication for endotracheal intubation for mechanical ventilation
- When sufficient information and a consent form for the study are obtained from the patient or the patient's guardian
Key exclusion criteria (10 listed)
- Coma with Glasgow score < 8
- Endotracheal intubation during CPR
- Contraindications for NIV: poor patient cooperation, recurrent vomiting, GI bleeding, severe craniofacial injury, upper airway obstruction, etc.
- Contraindications for RSI: complete upper airway obstruction, severe trauma obscuring cervical structures, etc.
- Implanted electronic medical devices (defibrillator, pacemaker or spinal cord stimulator)
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 |
|---|---|---|
| HFNCHigh-flow oxygen therapy before intubation for preoxygenation | Device | HFNC |
Primary outcome
Lowest SpO2
Time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Minimum SpO2 value during endotracheal intubation
6 secondary outcomes
EIT measurement
Time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
EIT measurement
Time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC in people with Acute Hypoxemic Respiratory Failure, run by Samsung Medical Center at 1 site in South Korea.
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 10 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: withdrawn, as of the sponsor's last update on 17 Apr 2024. 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 South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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?
Lowest SpO2 (time frame: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes 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 17 Apr 2024.