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

Sponsor

Centre Hospitalier Régional d'Orléans (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05409573

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critically Ill	Other: double monitoring of EtO2	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Non-comparative prospective interventional studyNon-comparative prospective interventional study

Masking:

None (Open Label)

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

Primary Purpose:

Other

Official 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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: monitoring of the expired oxygen fraction 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)	Other: double 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)

Arm

Intervention/Treatment

Experimental: monitoring of the expired oxygen fraction

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)

Other: double monitoring of EtO2

Outcome Measures

Primary Outcome Measures

Percentage of expired O2 at facemask during preoxygenation [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.
Percentage of expired pharyngeal O2 during preoxygenation [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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