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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05409573
Acronym
IMPROVE-Pre
Enrollment
30
Registered
2022-06-08
Start date
2022-12-23
Completion date
2027-12-01
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill

Keywords

Preoxygenation, intubation, end-tidal of oxygen, intensive care unit, critically ill patients

Brief summary

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.

Detailed description

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.

Interventions

OTHERdouble monitoring of EtO2

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)

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

The clinician and caregivers in charge of the patient during the intubation procedure will be blinded: the facemask EtO2 and pharyngeal EtO2 will not be visible on the monitor for them

Intervention model description

Non-comparative prospective interventional study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of expired O2 at facemask during preoxygenationHour 1compare 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.
Percentage of expired pharyngeal O2 during preoxygenationHour 1compare 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

MeasureTime frameDescription
Number of patient who had a pulsed oxygen saturation under 90%Hour 1Hypoxemia 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.

Countries

France

Contacts

CONTACTMai-Anh NAY, PH
mai-anh.nay@chr-orleans.fr+33238575253
PRINCIPAL_INVESTIGATORMai-Anh NAY, PH

CHR d'Orléans

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026