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PreoxygenationIMPROVENCT04148443

Impact of Preoxygenation Time on End-tidal Oxygen Concentration and on Hypoxic Events Occurring After Intubation in the Intensive Care Unit.

A study testing Preoxygenation and Preoxygenation (longer) in people with Preoxygenation and Intubation, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Preoxygenation is recommended before performing tracheal intubation. In intensive care units (ICU) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Preoxygenation, Intubation, Intensive Care Unit
What is being tested?
Preoxygenation and Preoxygenation (longer)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesFrance
Study dates
Dec 2023to Dec 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

  • Patients older than 18 years
  • Requiring intubation in ICU
  • Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not present

Who cannot join

  • Intubation for cardiac arrest
  • End-tidal oxygen concentration monitoring not available
  • Preoxygenation with high-flow nasal oxygenation
  • Previous participation to the study
  • Patient known, at time of inclusion, as being under guardianship, tutorship or curator
  • Pregnancy or breastfeeding
  • Lack of social security number

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • CH de DAX

    Dax, 40100

  • CHR d'Orléans

    Orléans, 45067

  • CHRU de TOURS

    Tours, 37000

Other trials in France

About this study

Preoxygenation is recommended before performing tracheal intubation. In intensive care units (ICU) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. Monitoring the effectiveness of preoxygenation with end-tidal oxygen concentration (EtO2) is strongly recommended in the operating room but it is never used in ICUs. The first aim of this pilot study is to assess the effect of the preoxygenation duration on EtO2, and secondarily, as an exploratory objective, to determine whether targeting a given value of EtO2 during preoxygenation might insure a safer intubation than when targeting pulse oximetry (SpO2).

Read the detailed description

This is a multicenter randomized controlled pilot study. 110 patients who require intubation in the ICU will be randomly assigned, with a 1:1 ratio, to 3 or 5 minutes of preoxygenation duration. EtO2 will be continuously measured but hidden to the clinician. The primary outcome measure will be the obtention of an optimal preoxygenation defined by an EtO2 >90%. Secondary outcomes include the occurrence of hypoxia and complications during the procedure.

A pulse oximetry (SpO2) greater than or equal to 96% (SpO2 ≥ 96%) at the end of preoxygenation will be the target in each group. If at the end of the preoxygenation, SpO2 is still lower than 96%, clinician will be allowed to extend the duration of preoxygenation (up to 5 minutes in the 3 minutes period of preoxygenation group and up to 8 minutes in the 5 minutes period of preoxygenation group).

End-tidal oxygen concentration (EtO2) will be measured during preoxygenation and will be hidden to the clinician in order to not influence the duration of preoxygenation.

Being tested
Preoxygenation, Preoxygenation (longer)
Keywords
preoxygenation, intubation, end-tidal of oxygen concentration, intensive care unit, critically ill patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PreoxygenationOther

    participants will receive 3 minutes of preoxygenation before intubation

  • Preoxygenation (longer)Other

    participants will receive 5 minutes of preoxygenation before intubation

Study groups in NCT04148443
Study groupRoleWhat they receive
3 minutes period of preoxygenationExperimental3 minutes of preoxygenation : participants in this group will receive 3 minutes of preoxygenation before intubation
Receives: Other: Preoxygenation
5 minutes period of preoxygenationExperimental5 minutes of preoxygenation: participants in this group will receive 5 minutes of preoxygenation before intubation
Receives: Other: Preoxygenation (longer)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients who reach an EtO2 of 90%

    To compare the percentage of patients who reach an EtO2 of 90% or higher (optimal preoxygenation) at the end of the preoxygenation period between patients randomized in the 3-min and those randomized in the 5-min preoxygenation duration group.

    Measured: 3 minutes

Secondary outcomes (8)

  1. Expired oxygen fraction (FeO2)

    FeO2 will be recorded at the end of the preoxygenation period

    Measured: end of the preoxygenation period

  2. Incidence of hypoxemia

    Hypoxemia will be defined by SpO2<90% during the intubation procedure

    Measured: 5 minutes after intubation

  3. Incidence of severe hypoxemia

    Severe hypoxemia will be defined by SpO2<80% for more than 5 seconds during the intubation procedure from the end of preoxygenation to 5 minutes after invasive mechanical ventilation

    Measured: End of preoxygenation

  4. Incidence of severe complications

    Severs complications occuring within 30 minutes following the intubation procedure will be evaluate and compare between the two groups

    Measured: 30 minutes after intubation

  5. Lowest Pulsed saturation with Oxygen (SpO2)

    The lowest SPO2 obtained within 30 minutes after the end of preoxygenation will be compared between the 2 groups

    Measured: 30 minutes after the end of preoxygenation

  6. Expired oxygen fraction (FeO2)

    FeO2 during preoxygenation will be recorded every minutes

    Measured: Through preoxygenantion, i.e., an average of 4 minutes (a minimum of 3 and a maximum of 8 minutes)

  7. Partial Pressure of Oxygen (PaO2)

    Measurement of PaO2

    Measured: 0 minute

  8. Partial Pressure of Oxygen

    Measurement of PaO2 at the end of the preoxygenation

    Measured: at the 4th minute on average (3rd or 5th minute depending on the randomisation group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study startDec 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: No inclusion after the 2 years of approval of the human subject review, even after 2 years of prorogation

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot study Randomized controlled multicenter trial Ratio 1:1
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04148443
Sponsor's protocol ID
CHRO-2019-11
Acronym
IMPROVE
Status last verified
Jun 2024
First submitted
5 Sep 2019
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.

    PubMed 22318634

  • Thille AW, Frat JP, Brun-Buisson C. Trends in use and benefits of non-invasive ventilation as first-line therapy in acute respiratory failure. Intensive Care Med. 2014 Aug;40(8):1179-80. doi: 10.1007/s00134-014-3370-0. Epub 2014 Jun 25. No abstract available.

    PubMed 24962719

  • Ozsancak Ugurlu A, Sidhom SS, Khodabandeh A, Ieong M, Mohr C, Lin DY, Buchwald I, Bahhady I, Wengryn J, Maheshwari V, Hill NS. Use and outcomes of noninvasive positive pressure ventilation in acute care hospitals in Massachusetts. Chest. 2014 May;145(5):964-971. doi: 10.1378/chest.13-1707.

    PubMed 24480997

Questions about this trial

What is this clinical trial studying?

A study testing Preoxygenation and Preoxygenation (longer) in people with Preoxygenation and Intubation, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.

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 3 inclusion and 7 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 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

Percentage of patients who reach an EtO2 of 90% (time frame: 3 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04148443, which also lists 3 linked publications.

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 27 Jun 2024.

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