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NCT Number: NCT05409573

Feasibility of End-tidal Oxygen Concentration Monitoring During Preoxygenation for Intubation in the Intensive Care Unit.

Intubation is a common procedure in the intensive care unit. Hypoxemia is the most frequent complication of this procedure.

Monitoring the end-tidal of oxygen is recommended in operating room (OR). End-tidal of oxygen (EtO2) >90% is an indication of a correct preoxygenation.

This monitoring is not used in routine in intensive care unit (ICU). There is no recommendation on the monitoring of end-tidal of oxygen in intensive care unit. In practice, clinicians use pulsed oxygen saturation (SpO2) to determine whether the patient is sufficiently preoxygenated. However, this parameter is not a good indicator of a correct preoxygenation.

In the OR, patients are compliant during the preoxygenation period and the measure of EtO2 with the face mask monitor is considered reliable because i) mask leakage is minimal and ii) the patient can breathe slowly and regularly.

Theses conditions are not available in critical ill patients requiring emergency intubation. EtO2 measured on the facemask may not reflect true EtO2.

This concern about the reliability of EtO2 measurement via the facemask justifies that we conduct a study to compare EtO2 measured on a facemask (facemask EtO2) to EtO2 measured in pharynx (via e nasopharyngeal catheter).

The aim of this study is to determine whether the measurement of EtO2 on facemask is reliable in patients in ICU.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR d'ORLEANS

Orléans, France

Location status: Recruiting

Location contact

Aurélie DESPUJOLS

CONTACT

May Anh NAY, PH

PRINCIPAL_INVESTIGATOR

About this study

This is a prospective non-comparative interventional study.

A double monitoring of EtO2 will be performed during the procedure of intubation (from the beginning of the preoxygenation to the success of intubation):

  • In the pharynx (via a nasopharyngeal catheter) for the needs of the study
  • On the facemask (as the practice in the OR) The duration of the study will not exceed one hour, including the installation of the devices.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Requiring an intubation in ICU for acute respiratory failure defined as a respiratory rate ≥ 25/min or clinical signs of respiratory distress or hypoxemia defined as oxygen requirement ≥ 15L/min or FiO2 ≥80% to maintain SpO2 ≥92% or a PaO2/FiO2 ratio <100 mmHg
  • With preoxygenation by noninvasive ventilation

Exclusion criteria

  • Intubation for cardiac arrest
  • EtO2 monitoring not available
  • Pulsed oxygen saturation monitoring specific for the study not available
  • Preoxygenation by high-flow nasal oxygen therapy or bag-mask ventilation
  • Allergy to lidocaine (for local nasal anesthesia)
  • Previously
  • Patient not affiliated or excluded from social protection, or under law protection (namely minors, pregnant or breastfeeding women, persons deprived of their liberty by court or administrative decision)
  • Previously included in the study

Treatment and study plan

double monitoring of EtO2

Other

A double monitoring of EtO2 will be performed during the procedure of intubation (from the beginning of the preoxygenation to the success of intubation):

  • In the pharynx (via a nasopharyngeal catheter) for the needs of the study
  • On the facemask (as the practice in the OR)

Primary outcomes

  1. Percentage of expired O2 at facemask during preoxygenation

    Time frame: Hour 1

    compare facemask EtO2 to pharyngeal EtO2 during preoxygenation in order to know if facemask monitoring is sufficient or if a nasopharyngeal catheter is absolutely necessary to monitor alveolar oxygenation.

  2. Percentage of expired pharyngeal O2 during preoxygenation

    Time frame: Hour 1

    compare facemask EtO2 to pharyngeal EtO2 during preoxygenation in order to know if facemask monitoring is sufficient or if a nasopharyngeal catheter is absolutely necessary to monitor alveolar oxygenation.

Secondary outcomes

  1. Number of patient who had a pulsed oxygen saturation under 90%

    Time frame: Hour 1

    Hypoxemia is defined as the occurrence of a pulsed oxygen saturation (SpO2) ≤ 90%. The end of preoxygenation is defined by the induction of anesthetics drugs. Successful intubation is defined by the presence of 3 identical waveforms on the capnograph.

Study contacts

Contact information is provided by the study sponsor or research team.

Mai-Anh NAY, PH

CONTACT

[email protected]

+33238575253

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Feasibility of End-tidal Oxygen Concentration Monitoring During Preoxygenation for Intubation in the Intensive Care Unit. First Part, Preliminary Study of the IMPROVE Global Project

Acronym: IMPROVE-Pre

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2022
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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