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Obesity is a risk factor for difficult intubation, with an incidence of up to 15.5%, and difficult mask ventilation. Obesity also reduces the functional residual capacity (FRC) of the lungs, the main reservoir of oxygen during apnoea. Complications associated with induction and intubation in the operating room are more frequent in obese patients. Preoxygenation is a cornerstone in the management of patients at risk of desaturation during induction. The study aims to compare two oxygenation strategies , in obese patients. Oxygenation using a combination of NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) compared with NIV alone in the operating room for induction of general anaesthesia with orotracheal intubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined oxygenation procedure | Active Comparator |
| |
| Single oxygenation procedure | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) | Procedure | Combination of two procedures Preoxygenation prior to intubation with NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen). During intubation, NIV is stopped and apneic oxygenation is maintained with HFNO |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen reserve | The lowest level of end-tidal oxygen concentration (EtO2) | 2 minutes after intubation |
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 | Peripheral oxygen saturation | during preoxygenation; before intubation; during intubation; after intubation; 2 minutes after intubation |
| Rate of EtCO2 | End-tidal carbon dioxide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ségolène MROZEK, MD, PhD | Clinique Pasteur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont Ferrand - Site Estaing | Clermont-Ferrand | 63100 | France | |||
| Clinique Honoré Cave |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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|
| NIV (Non Invasive Ventilation) | Procedure | Single procedure Preoxygenation prior to intubation with NIV (Non Invasive Ventilation). |
|
| 2 minutes after intubation |
| Patient tolerance | Numerical Rating Scale (NRS) [minimum value 0, maximum value 10] higher score mean a better outcome | Day 2, at study end |
| Adverse events | moderate and severe complications | Perioperative/Periprocedural |
| Montauban |
| 82000 |
| France |
| Hôpital Saint Eloi - CHU Montpellier | Montpellier | 34295 | France |
| Clinique Mutualiste La Sagesse | Rennes | 35000 | France |
| Clinique Pasteur | Toulouse | 31000 | France |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |