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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
Show all 10Show fewer
  • BMI > 50
  • Polydipsia
  • Unmeasurable SpO2
  • Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Samsung Medical Center

    Seoul, Gangnam, 06351

Other trials in South Korea

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.

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 groups in NCT05962073
Study groupRoleWhat they receive
NIVNo interventionNon-invasive ventilation application for preoxygenation
HFNCActive comparatorHigh 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.

  1. 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)
  1. EIT measurement

    Change of T2-T1

    Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)

  2. EIT measurement

    Change of △EILI

    Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)

  3. EIT measurement

    Change of △EELI

    Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)

  4. EIT measurement

    Change of Overdistension

    Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)

  5. EIT measurement

    Change of Collapse

    Measured: at day1(before, during and after preoxygenation and at 5 minutes and at 30 minutes after intubation)

  6. 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.

  1. First posted27 Jul 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion30 Jul 2024 (estimated)

Why it stopped: Not approved for ethics

Resources

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)
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

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.

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