Effect of the Duration of Pre-oxygenation on Apnea Tolerance in Obese Patients During the Induction of General Anesthesia (OBE_PreOx)

April 13, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Effect of the Duration of Pre-oxygenation (3 Minutes vs 6 Minutes) on Apnea Tolerance in Obese Patients (BMI> 30 kg / m2) During the Induction of General Anesthesia

The occurrence of arterial oxygen desaturation (hypoxemia) during the induction of general anesthesia remains one of the main causes of complications and mortality in anesthesia. In a healthy patient breathing in ambient air [Inspired O2 fraction (FiO2) = 21%] before the onset of narcosis, a drop in arterial O2 saturation (SpO2) occurs within 1 to 2 minutes. When pre-oxygenation is performed for 3 minutes in healthy subjects with FiO2 = 100%, SpO2 is less than 97% after 7.9 minutes of apnea and arterial O2 desaturation (SpO2 <93%) occurs after 8 to 9 minutes. For this reason and "in order to prevent arterial desaturation during tracheal intubation or supraglottic device insertion maneuvers", it is recommended "to systematically perform a pre-oxygenation procedure (3 min / 8 deep breaths) , including in the context of an emergency ". Tolerance to apnea is conditioned by the amount of O2 stored during the pre-oxygenation phase. Oxygen is transported to different tissues in 2 forms: combined with hemoglobin (Hb) and in dissolved form. In ambient air, the quantity of O2 transported by the Hb is much greater than the part transported in dissolved form. However, when the patient breathes a gas enriched in O2, all the molecules of Hb are quickly saturated (SpO2 = 100%), while the content of dissolved O2 increases constituting a reserve allowing to increase the tolerance to apnea.

Under usual conditions (3 minutes pre-oxygenation with FiO2 = 1), tolerance to apnea is shorter in obese subjects. Arterial O2 desaturation occurs after 2-3 minutes of apnea in patients with grade III obesity [Body Mass Index (BMI)> 35 kg / m2]. In addition, arterial O2 desaturation is faster the higher the BMI is. In fact, in obese patients, the lung volumes that can be mobilized in the supine position are modified compared to the non-obese subject: decrease in vital capacity, decrease in expiratory reserve volume, increase in airway resistance, decrease in thoracic compliance. These changes are, in part, explained by the weight of tissue on the rib cage and abdomen leading to compression of the lungs and diaphragm. In addition, there is also an increase in oxygen consumption in patients with a BMI> 40.

Different techniques have been proposed to increase apnea tolerance in obese patients. For Dixon et al., The desaturation of the morbidly obese subject (BMI> 40 kg / m2) is less rapid after 3 minutes of pre-oxygenation carried out with the patient in a half-seated position at 25 °: 201 seconds against 155 seconds in the Control group. This additional time seems to correlate with the value of the arterial pressure in O2 (PaO2) measured at the end of the pre-oxygenation (442 vs 360 mmHg). Likewise, the proclive position (30 ° reverse Trendelenburg) during the pre-oxygenation phase seems effective in limiting the occurrence of desaturation after induction.

The O2 reserve is usually assessed by measuring the partial pressure of O2 in the arterial blood. A value greater than 100 mmHg indicates that an amount of O2 is "in reserve", increasing tolerance to apnea. In practice, this examination is not feasible in current practice because it requires the performance of an invasive procedure, cannot be measured continuously and the rendering of the result is delayed by several minutes. In recent years, a technology based on spectrophotometry has been developed to measure the saturation of Hb in O2 in non-pulsatile blood. By algorithmic transformation, an Oxygen Reserve Index (ORI) is calculated. Its value varies from 0 to 1 and covers a data range between 100 and 200 mmHg of blood pressure in O2 (moderate hyperoxia). This data is obtained continuously and non-invasively from a sensor (RD Rainbow SET R Sensors; Masimo) placed on the 3rd or 4th finger of the hand. When a patient receives an O2 enriched gas mixture, the value of ORI increases rapidly and reaches a plateau. When the patient is in apnea, the drop in the ORI value precedes the drop in SpO2 by several tens of seconds. In a pilot study observing the kinetics of ORI in non-obese (BMI <25 kg / m2) or obese (BMI> 30 kg / m2) anesthetized patients, we observed that the time required to reach the plateau of l The ORI was longer (133 ± 30 seconds) in "obese" patients compared to "non-obese" patients (89 ± 28 seconds). Thus, one hypothesis to explain the poorer tolerance to apnea in obese patients would be that the duration of 3 minutes of pre-oxygenation as recommended in the recommendations is insufficient.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Groupe Hospitalier Paris Saint-Joseph
      • Paris, Groupe Hospitalier Paris Saint-Joseph, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged ≥ 18 years
  • Patient to have general anesthesia
  • Patient affiliated to a health insurance plan
  • French-speaking patient
  • Patient who has given free, informed and written consent

Exclusion Criteria:

  • Patient with a BMI between 25 and 30 kg / m2
  • Patient with a BMI> 40 kg / m2
  • Patient whose O2 stock is insufficient, without this being linked to obesity
  • Patient with severe respiratory pathology (COPD stage 3 or 4, severe asthma)
  • Patient with active smoking
  • Patient with a history of lobectomy or pneumonectomy
  • Patient coming for emergency surgery
  • Patient with a known allergy to rocuronium or sufentanil or propofol
  • Pregnant or breastfeeding women
  • Patient under guardianship or curatorship
  • Patient deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Patients with a BMI <25 kg / m² requiring general anesthesia with a pre-oxygenation for 3 minutes
Other: Control
All patients are installed with a 30 ° proclive and have pre-oxygenation (FiO2 = 1) with a face mask. At the end of the 3-minute pre-oxygenation for the "Control" group, the values of ORI, SpO2, mean arterial pressure and heart rate are recorded.
Experimental: PreOx_3min
Patients with a BMI between 30 kg / m² and 40 kg / m² requiring general anesthesia randomized to the pre-oxygenation group for 3 minutes
Other: PreOx_3min

Patients with a BMI between 30 kg / m² and 40 kg / m² are distributed according to a random allocation in the group "PreOx_3min".

All patients are installed with a 30 ° proclive and have pre-oxygenation (FiO2 = 1) with a face mask. At the end of the 3-minute pre-oxygenation for the "PreOx_3min" group, the values of ORI, SpO2, mean arterial pressure and heart rate are recorded.
Experimental: PreOx_6min
Patients with a BMI between 30 kg / m² and 40 kg / m² requiring general anesthesia randomized to the pre-oxygenation group for 6 minutes
Other: PreOx_6min

Patients with a BMI between 30 kg / m² and 40 kg / m² are distributed according to a random allocation in the group "PreOx_6min".

All patients are installed with a 30 ° proclive and have pre-oxygenation (FiO2 = 1) with a face mask. At the end of the 6-minute pre-oxygenation for the "PreOx_3min" group, the values of ORI, SpO2, mean arterial pressure and heart rate are recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea tolerance
Time Frame: End of pre-oxygenation 3 min versus 6 min
This outcome is to compare the duration of apnea tolerance (SpO2 value ≤ 94%) in obese patients (30 kg / m2 <BMI <40 kg / m2) depending on the duration of pre-oxygenation (3 minutes vs 6 minutes) during induction of general anesthesia compared to non-obese subjects (BMI <25 kg / m2).
End of pre-oxygenation 3 min versus 6 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORI profile
Time Frame: End of pre-oxygenation 3 min versus 6 min
This outcome is to evaluate ORI profile in obese patients according to the duration of pre-oxygenation.
End of pre-oxygenation 3 min versus 6 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2021

Primary Completion (Anticipated)

February 27, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • OBE_PreOx

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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